Status:
COMPLETED
FODMAP Reintroduction in Irritable Bowel Syndrome
Lead Sponsor:
University of California, Los Angeles
Conditions:
Irritable Bowel Syndrome With Diarrhea
Irritable Bowel Syndrome With Mixed Bowel Habits
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the amount and timing of when certain Fermentable Oligo-Di-Monosaccharides and Polyols (FODMAPs), specifically fructose, can be safely reintroduced into the d...
Detailed Description
Research supports clinical experience that ingestion of food often triggers the emergence or exacerbation of symptoms in the majority of patients with irritable bowel syndrome (IBS). While IBS remains...
Eligibility Criteria
Inclusion
- Adults (18+ years or older) with a diagnosis of IBS-D or IBS-M based on Rome IV criteria
- Diarrhea must occur 2 or more days per week
- Patients on current pharmacological therapy for their gastrointestinal complaints can enroll in the study as long as they have been on a stable dose for at least 30 days.
Exclusion
- Significant comorbidities that are associated with GI symptoms (e.g. diabetes, scleroderma, SLE), history of GI surgery excluding appendectomy, or prior organic GI illness
- Antibiotics taken in the past 2 months
- Current disordered eating patterns (diagnosed eating disorder; as per verbal ESP questionnaire)
- Current history of greater than moderate alcohol intake (more than 1 drink per day for women, more than 2 drinks per day for men, binge drinking behavior of 5+ drinks in a single session once per week)
- Cannot have had a cholecystectomy in the past 6 months prior to enrollment
Key Trial Info
Start Date :
March 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03245645
Start Date
March 24 2017
End Date
June 30 2023
Last Update
July 11 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA
Los Angeles, California, United States, 90095