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Time Restricted Feeding for Crohn's Disease (TRF-CD Trial)

N/A
Waitlist Available
Led By Dana J Lukin, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0); 4 weeks after incorporating time restricted feeding into diet
Awards & highlights

TRF-CD Trial Summary

This trial will test whether time-restricted fasting improves outcomes for Crohn's disease patients by reducing inflammation and favorably influencing the gut microbiome.

Eligible Conditions
  • Crohn's Disease

TRF-CD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TRF-CD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0); 4 weeks after incorporating time restricted feeding into diet
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0); 4 weeks after incorporating time restricted feeding into diet for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Inflammatory Markers as measured by blood C-reactive protein (CRP).
Change in inflammatory markers as measured by fecal calprotectin lab results
Change in patient reported outcomes as measured by Patient Recorded Outcome 2 (PRO2) scores.
Secondary outcome measures
Change in taxonomic composition of the gut microbiome as measured by Polymerase Chain Reaction (PCR) analysis.
Markers of systemic peripheral blood immunity as measured by Mass Cytometry by Time-Of-Flight (CyTOF) analysis.

TRF-CD Trial Design

1Treatment groups
Experimental Treatment
Group I: Time Restricted FeedingExperimental Treatment1 Intervention
Subjects will be required to fast for 16 consecutive hours daily for 4 weeks. The registered dietitian will provide subjects counseling on the intermittent fasting regimen.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,329,857 Total Patients Enrolled
The Kenneth Rainin FoundationUNKNOWN
Dana J Lukin, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

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Recent research and studies
~4 spots leftby Mar 2025