The Impact of Time Restricted Feeding in Crohn's Disease

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04271748

19-11021081

Ages > 18
All Genders

Study 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 been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects has active Crohn's disease of the ileum and/or colon. The diagnosis should beconfirmed by endoscopic or radiological evidence.
Active inflammation on colonoscopy performed as evidenced by an SES-CD ≥ 6 (or ≥ 4 forisolated 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

Exclusion Criteria:

Subjects who decline to provide informed consent
Subject with a history of an eating disorder, major gastrointestinal surgery withinthe 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 berequired to have a 2-week wash-out period.

Study Design

January 14, 2021

November 01, 2022

Connect with a study center

Weill Cornell Medicine
New York, New York 10065
United States
Site Not Available

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