Study Stopped
This study has been stopped due to difficulty with enrollment.
Treating Chronic Pouchitis With a Low FODMAP Diet
1 other identifier
interventional
N/A
1 country
1
Brief Summary
We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2020
CompletedFirst Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
November 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2022
CompletedFebruary 13, 2023
February 1, 2023
2 years
November 17, 2020
February 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Difference in Fecal Calprotectin
6 weeks
Secondary Outcomes (3)
Mean Difference in Composite Symptom Scores
6 weeks
Mean Difference in Cleveland Global Quality of Life Score
6 weeks
Rate of Normalization of Fecal Calprotectin
6 weeks
Study Arms (2)
Regular Diet
OTHERLow FODMAP
EXPERIMENTALInterventions
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.
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 Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Medicine Digestive Health Center
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen B Hanauer, MD
Northwestern University Feinberg School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 17, 2020
First Posted
November 23, 2020
Study Start
October 27, 2020
Primary Completion
October 27, 2022
Study Completion
October 27, 2022
Last Updated
February 13, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share