Status:
COMPLETED
The Impact of Time Restricted Feeding in Crohn's Disease
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
The Kenneth Rainin Foundation
Conditions:
Crohn's Disease (CD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has bee...
Eligibility Criteria
Inclusion
- Subjects has active Crohn's disease of the ileum and/or colon. The diagnosis should be confirmed by endoscopic or radiological evidence.
- Active inflammation on colonoscopy performed as evidenced by an SES-CD ≥ 6 (or ≥ 4 for isolated ileal disease) OR C-Reactive protein ≥ 1.0 mg/L OR fecal calprotectin ≥ 250 μg/g. Any or all of these results must be from within 180 days of study entrance.
- Subject should have BMI of \>18.5 and \<40
Exclusion
- Subjects who decline to provide informed consent
- Subject with a history of an eating disorder, major gastrointestinal surgery within the past 3 months.
- Subject with a history of antibiotic use within 4 weeks.
- Subject with a history of bowel obstruction within the past 12 months
- Subject with a history of diabetes requiring medication
- Subject who is currently pregnant or breastfeeding will be excluded
- Subjects with current antibiotic use. In order to participate, subjects will be required to have a 2-week wash-out period.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04271748
Start Date
January 14 2021
End Date
November 1 2022
Last Update
January 31 2023
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10065