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Treating Chronic Pouchitis With a Low FODMAP Diet

Primary Purpose

Pouchitis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low FODMAP Diet
Regular Diet
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pouchitis focused on measuring Low FODMAP Diet, Pouchitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern Medicine Digestive Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Regular Diet

Low FODMAP

Arm Description

Outcomes

Primary Outcome Measures

Mean Difference in Fecal Calprotectin

Secondary Outcome Measures

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)
Mean Difference in Cleveland Global Quality of Life Score
Rate of Normalization of Fecal Calprotectin

Full Information

First Posted
November 17, 2020
Last Updated
February 9, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04640155
Brief Title
Treating Chronic Pouchitis With a Low FODMAP Diet
Official Title
Treating Chronic Pouchitis With a Low FODMAP Diet
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
This study has been stopped due to difficulty with enrollment.
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
October 27, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pouchitis
Keywords
Low FODMAP Diet, Pouchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular Diet
Arm Type
Other
Arm Title
Low FODMAP
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Low FODMAP Diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Regular Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Difference in Fecal Calprotectin
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Mean Difference in Composite Symptom Scores
Description
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
Title
Mean Difference in Cleveland Global Quality of Life Score
Time Frame
6 weeks
Title
Rate of Normalization of Fecal Calprotectin
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B Hanauer, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine Digestive Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Treating Chronic Pouchitis With a Low FODMAP Diet

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