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Diet Reintroduction Study in Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT03052439
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Shanti Eswaran, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: FODMAP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Food items will be blindly reintroduced, and symptoms will be measured.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants blinded to randomization of order of reintroduction; Investigators blinded to order of reintroduction
Primary Purpose: Treatment
Official Title: Charting a Course to a Less Restrictive Diet for IBS
Actual Study Start Date : July 5, 2017
Actual Primary Completion Date : April 22, 2020
Actual Study Completion Date : April 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
Active Comparator: Order 1
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
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.

Active Comparator: Order 2
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
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.

Active Comparator: Order 3
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
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.

Active Comparator: Order 4
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
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.

Active Comparator: Order 5
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
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.




Primary Outcome Measures :
  1. Abdominal Pain [ Time Frame: 1 week ]
    Daily score (0-10) for abdominal pain will be recorded. This will be averaged and compared to the baseline and run-in periods


Secondary Outcome Measures :
  1. Bloating [ Time Frame: 1 week ]
    Daily score (0-10) for bloating will be recorded. This will be averaged and compared to the baseline and run-in periods

  2. Stool Consistency [ Time Frame: 1 week ]
    Daily stool consistency score will be recorded. This will be averaged and compared to the baseline and run-in periods

  3. Stool Frequency [ Time Frame: 1 week ]
    Daily number of stools will be recorded. This will be averaged and compared to the baseline and run-in periods

  4. Stool urgency [ Time Frame: 1 week ]
    Daily score (0-10) for stool urgency will be recorded. This will be averaged and compared to the baseline and run-in periods

  5. Fatigue [ Time Frame: 1 week ]
    Daily score (0-10) for fatigue will be recorded. This will be averaged and compared to the baseline and run-in periods

  6. Sleep quality [ Time Frame: 1 week ]
    Daily score (0-10) for sleep quality will be recorded. This will be averaged and compared to the baseline and run-in periods



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient population:

Eligible non-constipated IBS (NC-IBS) patients will be invited to participate in a study that will provide double blinded, individual FODMAP challenges to patients who have responded to full dietary FODMAP restriction.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052439


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0362
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Shanti Eswaran, MD University of Michigan
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Responsible Party: Shanti Eswaran, Clinical Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03052439    
Other Study ID Numbers: HUM00122970
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases