Effect of a low-FODMAP diet intervention versus standard ... · Definition: A Functional ......

Effect of a low-FODMAP diet intervention versus standard care on gastrointestinal symptoms, quality of life, and nutrient intake in subjects with symptoms of Irritable Bowel Syndrome

Sarah Steinmetz

BS University of Illinois at Urbana ChampaignCommittee

Heather Rasmussen PhD, RDN, LDN

Hannah Roosevelt MS, RD, LDN, CNSC

Kathryn Keim PhD, RD, LDN

Agenda• Introduction• Purpose• Review of Literature• Objectives• Methods• Timeline• Questions

Introduction

• Irritable Bowel Syndrome� Definition: A Functional Gastrointestinal Disorder

(FGID) associated with abdominal discomfort caused by altered and/or abnormal bowel habits. Bloating, distension, and disordered defecation are commonly associated features

� Global prevalence in industrialized countries: 10%-15%� Estimated annual financial expenditure in US

secondary to IBS: $1353 million

Quigley EM, Abdel-Hamid H, Barbara G, et al. J Clin Gastroenterol. 2012;46(5):356-366. Canavan C, West J, Card T. Aliment Pharmacol Ther. 2014;40(9):1023-1034. Sandler RS, Everhart JE, Donowitz M, et al. Gastroenterology. 2002;122(5):1500-1511. Frank L, Kleinman L, Rentz A, Ciesla G, Kim JJ, Zacker C.. Clin Ther. 2002;24(4):675-89; discussion 674. Gralnek IM, Hays RD, Kilbourne A, Naliboff B, Mayer EAGastroenterology. 2000;119(3):654-660. Hungin APS, Whorwell PJ, Tack J, Mearin F. Aliment Pharmacol Ther. 2003;17(5):643-650.

Introduction

• Irritable Bowl Syndrome (IBS)� International reports of significant reduction in quality of life� Even more so than:

� Asthma� Type 2 diabetes� GERD

Hungin APS, Chang L, Locke GR, Dennis EH, Barghout V. Aliment Pharmacol Ther. 2005;21(11):1365-1375.

Introduction• Symptom management of IBSoNo “cure”oPhamaceuticals and psychological therapies§Limited§Expensive§Ineffective in the long-term

oA subset of patients with IBS report dietary triggers as IBS symptom inducement§Highly researched topic in the past decade

ØYet little is known about IBS dietary habits§Lead to the development of the low-FODMAP diet

Chang L, Lembo A, Sultan S. Gastroenterology. 2014;147(5):1149-72.e2. Monsbakken KW, Vandvik PO, Farup PG. Eur J Clin Nutr. 2006;60(5):667-672.Gibson PR, Shepherd SJJ Gastroenterol Hepatol. 2010;25(2):252-258.

IntroductionThe low-FODMAP dietoElimination of poorly absorbed, short-chain carbohydrates§ Oligosaccharides-fructans, fructo-oligosaccharides, galacto-

oligosacchardies§ Di-saccharides: lactose§ Mono-saccharides: fructose in excess of glucose§ Polyols: sorbitol, mannitol, xylitol, maltitol

oStudies have shown it is effective at alleviating symptoms of IBS§ Highly controlled studies with strict food provision§ Very little research regarding low-FODMAP diet in clinical practice§ Designed for a dietitian

§ Limited research on effectiveness of RD vs standard care

Gibson PR, Shepherd SJ. J Gastroenterol Hepatol. 2010;25(2):252-258.Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. Gastroenterology. 2014;146(1):67-75.e5.Ong DK, Mitchell SB, Barrett JS, et al. J GastroenterolHepatol. 2010;25(8):1366-1373.

Purpose of the StudyTo determine if an RD-administered low-FODMAP diet is more effective than standard care at changing gastrointestinal symptoms, nutrient intake, and quality of life in outpatients with symptoms of IBS

Review of LiteratureDiagnosing IBS

ROME III Diagnostic Critera*: Recurrent abdominal pain or discomfort** at least 3 days/month in the last 3 months associated with two or more of the following:

1. Improvement with defecation

2. Onset associated with a change in frequency of stool

3. Onset associated with a change in form (appearance) of stool

• *Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

• ** “Discomfort” means an uncomfortable sensation not described as pain.

• In pathophysiology research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation is recommended for subject eligibility.

http://www.romecriteria.org/assets/pdf/19_RomeIII_apA_885-898.pdf

Comorbidities:�Psychiatric disorders: oDepression§Anxiety§somatoform disorders

�Non-gastrointestinal Non-psychiatric disorders:oFibromyalgiaochronic fatigue syndromeotemporomandibular joint disorderochronic pelvic pain

Whitehead WE, Palsson O, Jones KR. Systematic review of the comorbidity of irritable bowel syndrome with other disorders: what are the causes and implications?

Functional Gastrointestinal Disorders (FGID):

• Celiac Sprue/Gluten Enteropathy

• Lactose intolerance• Inflammatory

Bowel Disease (IBD) (Crohn’sdisease & Ulcerative Colitis)

• Colorectal Carcinoma

• Fructose malabsorption

• Lymphocytic and collagenous colitis

• Acute diarrhea due to protozoa or bacteria

• Small intestinal bacterial overgrowth (SIBO) • Diverticulitis • Chronic

Constipation

Non Functional Gastrointestinal Disorders (FGID):• Endometriosis• Pelvic

inflammatory diseases

• Ovarian cancer

Gastroenterology. 2002;122(4):1140-1156. Ladabaum U, Boyd E, Zhao WK, et al. ClinGastroenterol Hepatol. 2012;10(1):37-45. Quigley EM, Abdel-Hamid H, Barbara G, et al. J Clin Gastroenterol. 2012;46(5):356-366.

Introduction-Diagnosing IBS

O'Donnell LJ, Virjee J, Heaton KW. BMJ. 1990;300(6722):439-440. Lewis SJ, Heaton KW. Scand J Gastroenterol. 1997;32(9):920-924. Drossman DA. Gastroenterology. 2006;130(5):1377-1390.

•Methods for IBS-symptom management:oPharmacologic therapyoPsychological therapy

• Pharmacologic Therapy: Guidelines from the American Gastroenterological Association InstituteSubtype Medication (Brand Name) Evidence Grade

IBS-C Linaclotide (Linzess) High

IBS-C Lubiprostone (Amitizia) Moderate

IBS-C Polyethylene Glycol (PEG) Laxatives (Miralax)

Low

IBS-D Rifaximin (Xifaxan) Moderate

IBS-D Alosetron (Lotronex) Moderate

IBS-D Loperamide (Imodium) Low

IBS-D Tricyclic Antidepressants (TCAs) Low

IBS-D Selective Serotonin Reuptake Inhibitors (Ex: Sarafem, Paxil, Celexa, Zoloft)

Low

Pain and Cramping Antispasmodics Low

Chang L, Lembo A, Sultan S. Gastroenterology. 2014;147(5):1149-72.e2.

• Dietary manipulation�Estimated that 20%-67% of patients with IBS believe their symptoms are dietary induced and exclude foods and beverages from their diets

�Common sources of food-related information patients use: �Primary care providers �Gastroenterologists�Naturopathic doctors�Personal experiences with symptom induction after eating certain foods�Internet

Monsbakken KW, Vandvik PO, Farup PG. Eur J Clin Nutr. 2006;60(5):667-672.Heizer WD, Southern S, McGovern S. J Am Diet Assoc. 2009;109(7):1204-1214.Endevelt R, Gesser-Edelsburg A. Patient Prefer Adherence. 2014;8:147-154.

Monsbakken et al. 2006• Oslo, Norway• Invited patients with IBS and perceived food

intolerances from OPPHED database to consultation with dietitian (n=84)oReporting of perceived food intolerance from

OPPHED questionnaire oData on foods avoided collected by dietitian in

consultation• No reporting of the latter data collection

instrument

Monsbakken KW, Vandvik PO, Farup PG. Eur J Clin Nutr. 2006;60(5):667-672.

Monsbakken et al. 2006



Table 1 continued; 1st column: perceived food intolerance, 2nd column: avoidance of that food

Monsbakken KW, Vandvik PO, FarupPG. Eur J Clin Nutr. 2006;60(5):667-672.

Dietitian’s assessment of subjects:• 10 subjects (12%) had an inadequate diet• 3 subjects ate hypocalorically• 2 avoided fat to the extreme • 2 had unvaried diet• 7 at risk of vitamin and mineral deficiency



Hayes et al. 2014• Cork, Ireland• Questionnaire

administered to subjects with IBS (n=135) and subjects without IBS (n=111) regarding perceived food intolerances, symptom induction and dietary changes

• No validation of questionnaire Hayes P, Corish C, O'Mahony E, Quigley EM. J Hum Nutr Diet. 2014;27 Suppl 2:36-47.

Hayes et al. 2014

Hayes P, Corish C, O'MahonyE, Quigley EM. J Hum NutrDiet. 2014;27 Suppl 2:36-47.

Long-Term Symptom Management in IBS

Pharmacologic Therapy

Psychological Therapy

Dietary Manipulation

Late 1980s-1990s: Individual carbohydrates and sugar alcohols induce IBS-related symptoms if malabsorbed

2000: Malabsorption of carbohydrates (fructose, lactose, and sorbitol) coexist and can induce IBS-related symptoms when ingested in a combination

2005: Compilation of short-chain carbohydrates and sugar alcohols can induce IBS-related symptoms when malabsorbed. Includes: fructose (when in excess of glucose), fructans (fructo-oligosaccharides and inulins), lactose, galacto-oligosaccharides, sorbitol, xylitol, mannitol, and maltitol.

Carbohydrate Composition and Digestion/Absorption Properties

Carbohydrate Molecular Component

Degree of Polymerization Hydrolase enzyme

Fructans (Inulin, Fructo-oligosacchardies) (FOS)

Linear or branched fructose oligosaccharide

Inulin: 2-60Fructo-Oligosaccharides: <10

Enzymes that digest β-(2-1) fructosyl-fructose glycosidic bonds *not in humans, universallymalasborbed

Galactans (Galacto-Oligosaccharides) (GOS)

Galactosemonomers with a terminal glucose unit

<10 α-galactosidase *not in humans,universally malabsorbed

Lactose Glucose + Galactose 2 Lactase *malabsorption if not enough lactase, levels differ per individual

“Free” Fructose- Fructose in excess of glucose

Fructose monomer 1 Transport protein GLUT5, GLUT 2 (apical membrane of intestinal epithelium) *malabsorption in all humans if fructose>glucose*possible to malabsorb free fructose

Polyols (Sugar alcohols) Sorbitol, mannitol, xylitol, maltitol

1-2 N/A, malabsorption is due to molecule size of polyol and size of absorptive epithelium, differs per individual

Gibson et al. Aliment Pharmacol Ther 2005; 21: 1399–1409.

FODMAPsF=FermentableO=Oligo-saccharides (Fructans, Galactans)D=Di-saccharides (Lactose)M=Mono-saccharides (Fructose in excess of glucose)andP=Polyols (Sorbitol, mannitol, xylitol, maltitol)

The FODMAP hypothesis:1) FODMAPs poorly absorbed2) Osmotic effect3) Water and undigested FODMAPs travel

to large intestine4) Fermentation5) Gas production6) The increase of fluid and gas production

in the large intestine cause diarrhea, bloating, gas, abdominal pain, and distention

Barrett et al. Aliment Pharmacol Ther 31, 874–882

Avoid

Safe to ConsumeGibson PR, Shepherd SJ. Am J Gastroenterol. 2012;107(5):657-66; quiz 667.

Gibson PR, Shepherd SJ. Am J Gastroenterol. 2012;107(5):657-66; quiz 667.

Low-FODMAP diet education (as designed by Gibson and Shepherd):

1) Qualitatively define the typical eating practices and style of the patient

2) Explain physiological framework

3) Give specific dietary instructions:� Avoid foods that contain significant free fructose in excess of glucose (unless complete fructose

absorption was demonstrated on breath hydrogen testing)� Encourage choice of foods where fructose and glucose are ‘in balance’, or where glucose is in excess of

fructose� Co-ingestion of free glucose to ‘balance’ excess free fructose problematic foods. � Limitation of dietary fructose load (in the form of free fructose or sucrose) per meal� Avoidance of fructans and galactans. � Restrict lactose-containing foods, if lactose malabsorption was demonstrated on breath hydrogen or

lactose tolerance testing.� Avoid polyols

4) Provide written material on lists of food to avoid with suitable alternatives, and meal plans (need minimum of 7-day food record for Hannah)

5) Discuss ways to identify and avoid FODMAPs when patient is unable to prepare his or her own food

Gibson PR, Shepherd SJ. Am J Gastroenterol. 2012;107(5):657-66; quiz 667.

Summary of Studies Assessing the Capability of FODMAPs to Induce Symptoms of Irritable Bowel Syndrome

Study Purpose Study Design/Number of Participants

Intervention Results Limitations

Shepherd et al. (2008)

To determine if dietary elimination is optimal method for gastrointestinal symptom relief in patients with IBS and FM, and if relief is due to restriction of fructose or all FODMAPs.

Randomized, double-blinded, quadruple-arm, crossover, placebo-controlled re-challenge trial

n=25 (IBS-D: n=12; IBS-C: n=5; IBS-A: n=8)

Run in period of >10 days on low-FODMAP diet followed by two-week administration of 1 of 4 test drinks (fructans, fructose, fructose+fructans, glucose) in patients with IBS and FM while on low-FODMAP diet. Dosage of test drinks increased as 2-week period progressed. Followed by washout period of 10 days minimum. All food was provided.

Dose-response relationship of overall gastrointestinal symptoms and increase in test drink dose except glucose (P<0.01). All test drinks except glucose worsened overall symptoms, pain, bloating, and wind (P<0.002), attributing all dietary FODMAPs to gastrointestinal symptom induction.

Few patients tolerated the highest dose of test drinks, reducing power. Physiologic responses to FODMAPs may differ when consumed as liquid versus solid form. No breath testing for glucose (placebo) malabsorption, potentially increasing placebo response rate.

IBS=Irritable Bowel SyndromeFC=Functional gastrointestinal symptom complaints; No specific diagnosis of a functional gastrointestinal disorderFM=Fructose MalabsorptionFODMAPs=Fermentable oligo-, di-, mono-saccharides and polyolsIBS-D=IBS with diarrhea; IBS-C: IBS with constipation; IBS-A: IBS with alternating symptoms

Shepherd SJ, Parker FC, Muir JG, Gibson PR. Dietary Triggers of Abdominal Symptoms in Patients With Irritable Bowel Syndrome: Randomized Placebo-Controlled Evidence. Clinical Gastroenterology and Hepatology. 2008;6(7):765-771.

Summary of Studies Assessing the Capability of FODMAPs to Induce Symptoms of Irritable Bowel Syndrome

Study Purpose Study Design/Numberof Participants

Intervention Results Limitations

Barrett et al. (2010)

To study the effects of ingested dietary FODMAPs on water and fermentable substrate content of ileal effluent.

Randomized, single blind, crossover intervention

n=10 subjects

Administration of 4-day test diets (one high in FODMAPs, one low in FODMAPs) to asymptomatic ileostamates. Followed by minimum 2-week washout period. All food was provided during dietary treatments.

Recovered 32% of ingested fructanson high-FODMAP diet in effluent. Water content of effluent on low-FODMAP diet decreased by 20% (P=0.013). Relationship between output water volume and total FODMAP content of output (r=0.685, P=0.035). 2 out of 4 subjects experienced gastrointestinal symptoms on both the high and low-FODMAP diet.

The only symptoms evaluated were abdominal pain, bloating, and nausea.

IBS=Irritable Bowel SyndromeFC=Functional gastrointestinal symptom complaints; No specific diagnosis of a functional gastrointestinal disorderFM=Fructose MalabsorptionFODMAPs=Fermentable oligo-, di-, mono-saccharides and polyolsIBS-D=IBS with diarrhea; IBS-C: IBS with constipation; IBS-A: IBS with alternating symptoms

BARRETT JS, GEARRY RB, MUIR JG, et al. Aliment Pharmacol Ther. 2010;31(8):874-882.

In Summary: Evidence that FODMAPs are capable of inducing IBS-related symptomsSo,Does this mean a low-FODMAP diet will actually improve IBS symptoms in patients with IBS?

The following studies aim to test the efficacy of the low-FODMAP diet in alleviating IBS symptoms and potential symptom markers in subjects exclusively with IBS

Ong et al.

�Objective: To examine the effects of diets varying in FODMAP content on the production of hydrogen and methane and gastrointestinal symptoms

�Methods:oPopulation: Subjects with IBS based on Rome III diagnostic criteria (n=15) vs healthy subjects without IBS (n=15)oStudy design:�Randomized, single-blind, crossover intervention�7-day baseline period§Completed: 7-day food diary, daily questionnaire about gastrointestinal symptoms and physical activity (not validated)

Ong DK, Mitchell SB, Barrett JS, et al. J GastroenterolHepatol. 2010;25(8):1366-1373

�Randomized to a 2-day high-FODMAP diet (HFD) of 50g/day FODMAPs or low-FODMAP diet (LFD) of 9g/day FODMAPs (all food provided)oSubjects blinded to diet administeredoDiets matched for total energy, starch, protein, and fatoQuantity of food provided determined by energy requirements of subjects calculated by Schofield equations

�Daily subjects recorded food and fluid consumed daily during study�Daily subjects completed baseline questionnaire on symptom severity and physical activity�7-day washout period �Breath samples collected hourly for 14 hrs on the second day of each dietary period, starting before breakfast


Red=healthy-HFDBlue=healthy-LFDGreen=IBS-HFDPurple=IBS-LFD


Ong et al. 2010

• ConclusionsoIncreased ingestion of FODMAPs produces more hydrogenoGreater hydrogen production seen in those with IBS

• LimitationsoShort study periodoOnly used a 4 point Likert scaleoQuestionnaires not validatedoDid not stratify any statistics based on IBS subtypeoNo stool patterns assessed


Staudacher et al. 2012

�Objective: To investigate the effects of fermentable carbohydrate restriction on the luminal microbiota, SCFA, and GI symptoms in patients with IBS.

�Methods:oPopulation: Subjects with IBS-D and bloating based on Rome III diagnostic criteria (n=41) oStudy design:�Randomized, control trial�7-day baseline period§Completed: GSRS, stool frequency and consistency using Bristol Stool Chart, food and fluid intake recorded in diary daily

�On 7th day submitted stool sample

Staudacher HM, Lomer MC, Anderson JL, et al. J Nutr. 2012;142(8):1510-1518.


• Randomized to either a 4 week low-FODMAP diet (n=19) or control (n=22)oControl group advised to continue normal dietoBoth groups advised to avoid pro/prebioticsoAll advice given my the same dietitian§Administered weekly phone calls and discussed FODMAP restriction (intervention only), pro/prebiotic avoidance, compliance, data recording, medications, and adverse events

oOn the fourth week all subjects completed:§7-day symptom, stool, and food diary§All baseline measurements


Proportion of subjects reporting symptom improvement at follow up



• ConclusionsoFour weeks of dietary restriction of fermentable short-chain carbohydrates resulted in lower incidence and severity of bloating and overall symptoms in subjects with IBS compared with controls

• LimitationsoControl group received no dietary adviceoCan not be extrapolated to those with IBS-C, IBS-M, or IBS-U


Halmos et al. 2014

�Objective: To compare gastrointestinal symptoms over 3 weeks on a low-FODMAP diet vs a typical Australian diet with moderate FODMAPs in patients with IBS compared to a healthy control

�Methods:oPopulation: Total participants: n=38

� IBS: n=30 (IBS-D: n=10, IBS-C: n=13, IBS-M: n=2, IBS-U: n=2); Healthy control: n=8

oStudy design:�Randomized, single-blind, crossover intervention�7-day baseline period

§ Completed daily: 7-day food diary, daily questionnaire about gastrointestinal symptoms (not validated) using VAS (0-100mm)

Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A Diet Low in FODMAPs Reduces Symptoms of Irritable Bowel Syndrome. Gastroenterology. 2014;146(1):67-75.e5.

Halmos et al. 2014

�Randomized to a 21-day low-FODMAP diet (LFD) of 3.05 g/day FODMAPs or moderate-FODMAP diet (typical Australian diet) of 24 g/day FODMAPs (almost all food provided)oSubjects blinded to diet administeredoDiets matched except for FODMAPsoQuantity of food provided determined by average energy requirement of 8 MJ/day


Halmos et al. 2014

�Daily subjects recorded: food and fluid consumed�Daily subjects completed: baseline VAS on symptom severity�21-day washout period


Symptom severity (VAS 0-100mm) by day


• ConclusionsoSymptoms halved in IBS subjects on LFD compared to HFDoSymptom improvement encompassed all IBS subtypesoSymptomatic benefits on LFD are nonspecific as controls

were unaffected by either diet

• LimitationsoPossible overestimation of oligosaccharides and polyol

contents in typical Australian diet-Can potentially exert laxative effect

oNot representative of clinical practiceoDid not use validated questionnairesoNo substantial objective results in fecal markers

Halmos et al. 2014

Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. Gastroenterology. 2014;146(1):67-75.e5.

Limitations of these studies (Ong et al. 2010, Staudacher et al. 2012, Halmos et al. 2014):�Not conducted in a US sample�Australian Studies (Ong/Halmos)oNo usage of validated questionnairesoInconsistent amounts of FODMAPs tested between the two studiesoNot a realistic representation of clinical practiceoNO RD

�British Study (Staudacher)oLow-FODMAP intervention not well describedoControl group did not receive dietary counselingoNo information on training of RDoStill not representative of clinical practice

Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. Gastroenterology. 2014;146(1):67-75.e5. Staudacher HM, Lomer MC, Anderson JL, et al. J Nutr. 2012;142(8):1510-1518. Ong DK, Mitchell SB, Barrett JS, et al. J GastroenterolHepatol. 2010;25(8):1366-1373

So…How are these studies replicated in clinical practice?

Bohn et al. 2015• Objective: �To perform a randomized, single-blind controlled trial to compare the effect of a low-FODMAP diet versus traditional dietary advice on IBS symptoms in Swedish outpatients with IBS in a setting resembling standard clinical practice

• Study Design:� Subjects randomized to a 4 week low-FODMAP diet (diet A)

(n=38) or traditional IBS diet (diet B) (n=37)�Patients were never informed of the “other” diet; word “FODMAPs” never mentioned

• Outcomes:� IBS symptom severity�Clinically significant improvement: > 50 on IBS-SSS

�Changes in bowel patterns�Assessment of Nutrient IntakeBohn L, Storsrud S, Liljebo T, et al. Gastroenterology. 2015.

•Results:�The IBS symptom severity was reduced in both groups at the end of the intervention period compared with baseline (p<0.0001 in both groups)

�The change in the IBS-SSS scores relative to baseline did not differ between the low FODMAP and traditional IBS group at day 14 (62±98 vs. 23±65; p=0.062) or day 29 (77±110 vs. 65±84; p=0.62)

� In the low-FODMAP group the number of bowel movements per day was reduced at the end of the treatment period relative to baseline (p<0.0001), whereas no significant effect was seen in the traditional IBS diet group

�The mean stool consistency did not change in both groups

Bohn L, Storsrud S, Liljebo T, et al. Gastroenterology. 2015.

• Results Contd� Both groups reduced calorie intake during the intervention

period, but the reduction was significantly larger in the low-FODMAP group

� The number of meals per day was increased in only the traditional IBS diet group during the intervention period, with a significant difference in the number of meals between the groups during the intervention period

� A higher proportion of IBS patients with diarrhea responded favorably to the low-FODMAP diet (70%) compared with IBS with constipation (44%) and IBS mixed/unsubtyped (42%) but was not statistically significant (p=0.34)

� No significant difference between IBS subgroups in reduction IBS symptom severity (IBS-SSS) were seen with the low-FODMAP diet (IBS with constipation: 60±152; IBS with diarrhea:70±103; IBS mixed/unsubtyped: 94±87; p=0.76)


Bohn et al. 2015•Conclusion:�Dietitian-administered dietary advice to patients with IBS in the clinical setting reduces GI symptoms, without differences between a low-FODMAP diet and traditional IBS dietary advice �Calorie and nutrient intake needs to be monitored thoroughly as both diets had a significant decrease in calories


Objectives• Describe changes IN GASTROINTESTINAL SYMPTOMS before and after complete FODMAPelimination by evaluating changes in THE self-reported patient questionnaire GSRS-IBS.• Describe changes IN NUTRIENT INTAKE before and after complete FODMAP elimination from VIOSCREEN FOOD FREQUENCY QUESTIONNAIRE. • Describe changes IN QUALITY OF LIFE before and after complete FODMAP elimination by evaluating changes in THE self-reported patient questionnaire IBS-QOL.

Methods• Randomized, delayed-controlled trialoIntervention: Complete FODMAP elimination administered by RD

vsoControl: Physician provided standard care�All participants in control group will go through intervention one month from baseline

• Assess changes in: oGastrointestinal symptoms onutrient intakeoquality of life

Methods• SampleoConvenience sampleoPatients of Rush University Medical Center Gastroenterologists with

IBSoSeptember 2015-March 2016

• Inclusion Criteriao>18 years oldoRecommendation to follow low-FODMAP diet by gastroenterologist

• Exclusion CriteriaoFlare ups of Crohn’s Disease/Ulcerative ColitisoAbnormal small intestinal villi identified by biopsyoRefusal to follow the low-FODMAP diet

Per Gastroenterologist

Methods: Recruitment and Consent

Patient referred to RD by gastroenterologist Appointment with RD

Patient schedules appointment with RD

Call patient prior to appointment and consent/HIPAA if interested Consent/HIPAA at beginning

of appointment if interested

Methods: Data Collection Tools•Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS-IBS)�Validated by Wiklund et al. 2003�13 questions total, 5 subscales (pain, bloating, diarrhea, constipation, satiety)�7 point Likert scale per question�Scored by: oquestion score (1-7) + question score (1-7) + etc/# questions in subcomponent or 13 (total questionnaire)oTotal questionnaire: minimum mean score=1, maximum mean score=7

�Reported in mean/SD�No reported scores indicating a clinically significant change

Methods: Data Collection ToolsIrritable Bowel Syndrome-Quality of Life (IBS-QOL)�Validated by Patrick et al. 1998 � 34 questions total, 8 subscales (dysphoria, activity interference, body image, health worry, food avoidance, social reaction, sexual, relationship)

� 5 point Liker scale per question�Scored by:oquestion score (1-5) + question score (1-5) + etc/# questions in subcomponent or 34 (total questionnaire)oTotal questionnaire: minimum mean score=1, maximum mean score=5

�Reported in mean/SD�No reported scores indicating a clinically significant change

Methods: Data Collection ToolsVioscreen Food Frequency Questionnaire�Online�Validated by Kirstal et al. 2014�Assess dietary intake over 30 day period�20 questions, 30 minutes�Nutrient and food report�FODMAPs in database: fructose, glucose, lactose, polyols

Methods: Data Collection Tools• Vioscreen FFQ

Methods: Randomization•Conducted in August 2015 by dietitian outside studyoRandom numbers generator via Excelo100 subject numbersoEnvelope labeled: 001, 002, 003, etc•Corresponds to subject #

oGroup assignment inside envelope•A=standard care•B=RD intervention

Methods: Data Collection

Visit 1 with RD• Complete FODMAP

elimination education• Complete

questionnaires (pre-measure)

Visit 2 with RD• Re-introduction of

FODMAPs • Complete

questionnaires (post measure)Follow-Up

Phone call with RD

Visit 1 with RD• Complete FODMAP

elimination education• Complete

questionnaires (post-measure)

Follow-Up Phone call with RD

Visit 2 with RD• Re-introduction of

FODMAPs

• No visit with RD• Complete

questionnaires (pre-measure)

End of StudyBaseline

Baseline

2 week follow up

Baseline

2 week follow up

1 month follow up1 month follow up

Intervention

Standard Care

Methods: Educational Materials

The Low-FODMAP diet was designed to be taught by an experienced Registered Dietitian Nutritionist (RDN). For maximal symptom improvement and prevention of nutritional deficiencies, please schedule an appointment with the Rush University Medical Center Gastroenterology RDN by e-mailing the Gastroenterology Clinic:

[email protected]

Methods: Educational Materials• Monash University low-FODMAP application for Smartphones: see attached

screen shots

• Monash University low-FODMAP booklet� Identical to smartphone application in booklet form

as• Education session:o Not mandatory to

download• Offered booklet

o $7.99 Apple/$9.00 Android

• Education session:oPhysiologic Mechanism• IBS• Carbohydrate

digestion• FODMAP

hypothesis

• Education Session:o Specific dietary

instructions• Food item

database

• Education session:oSpecific dietary

instructionsoStoplight system:• Red: Avoid

completely• Yellow: Eat up to the

specific serving size listed• Green: Do not avoid

o Customize settings

• Education session:o Specific dietary

instruction• Breakdown of

FODMAPs•Notes• Shopping list

• Education Session:o Recipeso 3-7-day food

record encouragement

o Personalized meal plan

Methods: Overall Role as Research Assistant• Communicate with RD• Excel sheet and calendar• Ensure all data entered into REDCap• Send out questionnaires• Questionnaire and appointment reminders• Observe when available• Communicate with patients via E-mail

Methods: Sample Size• Power analysis based on data from Ljottson et al. 2011• G-power used to calculate effect size• Significance level: 95%; power: 80%; Effect size: 0.79= 27 subjects

per intervention and control groupoN=54 total

• Data not based off dietary interventiono27 per group rounded to 30o20% added to account for dropout rates= 36 subjects needed for group

N=74 total

Methods: Statistics• Measures of central tendency (means + SD) � continuous demographic variables oBMIoAgeo length of IBS diagnosis.

• Frequency distributions� categorical demographic informationogender oIBS subtypeotest group (control or intervention)oprevious consult with dietitian (yes/nooprior attempts of following the low-FODAP diet (yes/no)

• Data will be examined for normality• nonparametric statistics if data are not normally distributed

• Significance will be set at p<0.05

Methods: StatisticsObjective 1: To compare changes in gastrointestinal symptoms between treatment groups over a one-month intervention through a self-reported patient survey (GSRS-IBS).

• Paired t-test o difference in gastrointestinal symptom scores pre and post treatment in both the control

and intervention group

• Independent t-testo compare intervention and standard care group at baseline and final intervention.

• ANOVAo difference in gastrointestinal symptom scores stratified by IBS subtypes of constipation,

diarrhea and mixed at both time points � Kruskal-Wallis If data are not normally distributed

• All scores reported as means + SD • The IBS-GSRS sub-scales will be compared between groups and

before and after treatment in the same manner

Methods: StatisticsObjective 2: Describe dietary intake both before and after the low-FODMAP complete elimination diet through the analysis of VioScreen food frequency questionnaire.

• Dietary intake of macronutrient and micronutrientsoreported on food frequency questionnaire output

� Independent t-test: compare between treatment groups at baseline and after intervention

� Paired t-test: compare before and after intervention within treatment group

• The HEI 2010 diet qualityoreported as part of the VioScreen food frequency questionnaire results

� Paired t-test: compare the mean diet quality score pre and post treatment in both the intervention and standard care group for all patients individually

� Independent t-test: compare the mean differences in diet quality pre and post treatment in the standard care group to RD intervention group

Methods: StatisticsObjective 3: To compare changes in gastrointestinal-related Quality of Life between treatment groups over a one-month intervention through a self-reported patient survey (IBS-QoL).

• Paired t-testo Determine the difference in quality of life scores pre and post treatment in both the control and

intervention group

• Independent t-test o Compare intervention and standard care group at baseline and final intervention

• ANOVAo Determine the difference in quality of life stratified by IBS subtypes of constipation, diarrhea

and mixed at both time pointso Kruskal-Wallis if data are not normally distributed

• All scores will be reported as means + SD

• IBS-QOL sub-scales will be compared between groups and before and after treatment in the same manner

Timeline•PROPOSAL: OCTOBER 2015•DATA COLLECTION: SEPT 2015-MARCH 2016•DATA ANALYSIS AND THESIS WRITING: MARCH- APRIL 2016•DEFEND MAY 2016

Effect of a low-FODMAP diet intervention versus standard ... · Definition: A Functional ......

Documents

Transcript of Effect of a low-FODMAP diet intervention versus standard ... · Definition: A Functional ......