Diet Reintroduction Study in Irritable Bowel Syndrome

NCT03052439 | Completed

• 1 other identifier: HUM00122970
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is the most common gastrointestinal disease, affecting 12% of the US population and up to 20% of the population worldwide. This is a condition that is diagnosed based on specific symptoms of altered bowel habits and abdominal pain, as well as the exclusion of select other GI diseases. IBS not only causes constipation, diarrhea, abdominal cramping, and bloating, it also significantly affects quality of life, overall functioning, and work productivity. The cause of IBS is likely multifactorial, which makes it a difficult disease to treat. However, patients often associate their IBS symptoms with eating a meal. Up to 90% of IBS patients restrict their diet to prevent or improve their symptoms, and patients are increasingly interested in more holistic approaches to disease management. At present, the most persuasive evidence that dietary changes can treat IBS supports a diet low in fermentable carbohydrates (the low FODMAP (fermentable oligo, di, and monosaccharides and polyols) diet). This diet, which is low in certain carbohydrates, has been shown to improve IBS symptoms (particularly abdominal pain and bloating), but can be difficult to follow and quite restrictive. In addition, this diet is not meant to be used as a maintenance diet; patients undergo an elimination phase followed by a reintroduction phase of specific carbohydrate groups as they monitor their symptoms. From the results of our proposed study, the study team hopes to arrive at a modified, less -restrictive version of the low FODMAP diet that is equally effective, and also create a standard protocol that patients can use during this reintroduction phase. Patients with IBS will be recruited into a 13-week trial that would help determine the optimal way in which high FODMAP foods should be introduced. After consent, patients would start on a low FODMAP diet for 14 days, and if their symptoms improve, they would be invited to continue in the study. For 7 days prior to the reintroduction of individual FODMAPs, patients will ingest 1daily servings of a low FODMAP nutrition drink to validate the low FODMAP content of this dietary supplement. If patients do not experience a flare of symptoms with the supplement, they enter the reintroduction period. During this period, subjects would introduce different groups of FODMAPs in a blinded fashion while remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms. At the end of the study period, subjects would be informed of the FODMAPs to which they were sensitive and would meet with a dietitian. At the completion of the study, the investigators would compile the data and determine which FODMAPs were mostly likely to exacerbate IBS symptoms, thus providing the construct for a modified low FODMAP diet, or "low FODMAP-Light." It is hoped that this modified, less restrictive version of the low FODMAP diet would be equally effective for the majority of IBS patients.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Abdominal Pain

  Daily score (0-10) for abdominal pain will be recorded. This will be averaged and compared to the baseline and run-in periods

  1 week

Secondary Outcomes (6)

• Bloating

  1 week

• Stool Consistency

  1 week

• Stool Frequency

  1 week

• Stool urgency

  1 week

• Fatigue

  1 week

Study Arms (5)

Order 1

ACTIVE COMPARATOR

Subjects would introduce 5 different groups of FODMAPs in a blinded fashion (random order, 1 week on, one week off) while remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms.

Other: FODMAP

Order 2

ACTIVE COMPARATOR

Subjects would introduce 5 different groups of FODMAPs in a blinded fashion (random order, 1 week on, one week off) while remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms.

Other: FODMAP

Order 3

ACTIVE COMPARATOR

Subjects would introduce 5 different groups of FODMAPs in a blinded fashion (random order, 1 week on, one week off) while remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms.

Other: FODMAP

Order 4

ACTIVE COMPARATOR

Subjects would introduce 5 different groups of FODMAPs in a blinded fashion (random order, 1 week on, one week off) while remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms.

Other: FODMAP

Order 5

ACTIVE COMPARATOR

Subjects would introduce 5 different groups of FODMAPs in a blinded fashion (random order, 1 week on, one week off) while remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms.

Other: FODMAP

Interventions

FODMAP OTHER

After 2 weeks on a low FODMAP diet, subject will undergo a reintroduction period. 5 different FODMAPs will be reintroduced (1 week at a time, followed by 1 week washout) in a blinded, randomized fashion.

Order 1; Order 2; Order 3; Order 4; Order 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, at least 18 years of age, able to provide informed consent
• Meet Rome IV criteria for IBS-C (constipation-predominant), IBS-D (diarrhea-predominant), IBS-M (mixed bowel habits) as assessed by a gastroenterologist
• Willingness to maintain a stable dosage of IBS medications during the pretreatment baseline period, including tricyclic antidepressants; "rescue" medications permitted (ie loperamide)
• For IBS-D patients only, documentation of normal colonoscopy or flexible sigmoidoscopy with colon biopsies within five years
• Documentation of normal TSH, CBC, CRP, electrolyte panel
• Negative evaluation for celiac disease either with normal TTG IgA, EMA, and/or duodenal biopsy.

You may not qualify if:

• Pregnancy
• IBS-U subtype (undetermined)
• Comorbid medical problems that may affect gastrointestinal transit or motility (inflammatory bowel disease, extra-intestinal disease known to affect the gastrointestinal system (scleroderma, unstable thyroid disease, uncontrolled diabetes mellitus, etc.), severe renal or hepatic disease
• Previous treatment with a low FODMAP diet or active participation in another form of dietary therapy
• Previous surgery to the GI tract except appendectomy or cholecystectomy if performed more than six months prior to enrollment.
• Medications not permitted include probiotics, antibiotics, laxatives, and narcotics

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109-0362, United States

Location

Related Publications (1)

• Eswaran S, Jencks KJ, Singh P, Rifkin S, Han-Markey T, Chey WD. All FODMAPs Aren't Created Equal: Results of a Randomized Reintroduction Trial in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2025 Feb;23(2):351-358.e5. doi: 10.1016/j.cgh.2024.03.047. Epub 2024 May 9.

  PMID: 38729390 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shanti Eswaran, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants blinded to randomization of order of reintroduction; Investigators blinded to order of reintroduction
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Food items will be blindly reintroduced, and symptoms will be measured.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 14, 2017
• Study Start: July 5, 2017
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)