Treating Chronic Pouchitis With a Low FODMAP Diet

Study Overview
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Brief Summary
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We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.

Detailed Description
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Following recruitment for entry into the study, subjects be asked to complete symptom surveys and provide a fecal sample for calprotectin measurement. Shortly after their screening visit, patients will be randomized 1:1 to either the low FODMAP diet (experimental) or regular diet (control) group. Patients in the experimental group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counseled regarding FODMAP containing foods. They will be asked to adhere to this diet over the next 6 weeks. At the end of the 6 week period, subjects will complete a 3-day food diary. Those in the regular diet group will be contacted by the dietician and given an educational handout at the beginning of the study period regarding best dietary practices. At the end of the 6 week study period, both groups will again be asked to complete another set of symptom surveys and provide a fecal sample for calprotectin measurement.

Official Title
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Treating Chronic Pouchitis With a Low FODMAP Diet

Conditions
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Pouchitis

Intervention / Treatment
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* Behavioral: Low FODMAP Diet
* Behavioral: Regular Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients aged 18-65 with a diagnosis of ulcerative colitis that have undergone ileal pouch-anal anastomosis following proctocolectomy for medication-refractory disease Either ≥4 episodes of pouchitis per year (antibiotic-dependent) OR persistent symptoms despite 4 weeks of antibiotic therapy (antibiotic-resistant) Exclusion Criteria Diagnosis of indeterminate colitis or Crohn's disease Celiac disease Current use of low FODMAP diet Known dietary allergies Current use of antibiotics for reasons other than treatment of pouchitis Clostridium difficile infection Complication following ileal pouch-anal anastomosis requiring reoperation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Regular Diet<br> | Behavioral: Regular Diet<br>* Patients in the regular diet group will receive an educational handout discussing low fiber diet, which is standard of care for those with pouchitis symptoms.<br>|
| Experimental: Low FODMAP<br> | Behavioral: Low FODMAP Diet<br>* Patients in the low FODMAP group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counselled regarding FODMAP containing foods and how to effectively remove them while maintaining a nutrition-rich diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Difference in Fecal Calprotectin |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Difference in Composite Symptom Scores | Composite symptom score will include both clinical portion of Pouchitis Disease Activity Index as well as Oresland score, with possible scores ranging from 0-21 (higher number indicates higher symptom burden) | 6 weeks | 
| Mean Difference in Cleveland Global Quality of Life Score |  | 6 weeks | 
| Rate of Normalization of Fecal Calprotectin |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low FODMAP Diet, Pouchitis