Treating Chronic Pouchitis With a Low FODMAP Diet

Northwestern University

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Pouchitis

Interventions

Low FODMAP DietBEHAVIORAL

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.

Regular DietBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Northwestern Medicine Digestive Health Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Mean Difference in Fecal Calprotectin

Time frame: 6 weeks

Secondary Outcomes

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)

Time frame: 6 weeks

Mean Difference in Cleveland Global Quality of Life Score

Time frame: 6 weeks

Rate of Normalization of Fecal Calprotectin

Time frame: 6 weeks

Data from ClinicalTrials.gov

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