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Intermittent Reduced Calorie Diet (IRCD) for Crohn's Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Crohn's Disease+2 MoreIntermittent Reduced Calorie Diet (IRCD) - Other
Eligibility
18 - 70
All Sexes
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Study Summary

This trial is investigating whether an Intermittent Calorie Reduced Diet that mimics fasting could help treat Crohn's disease by reducing inflammation.

Eligible Conditions
  • Crohn's Disease
  • Diet Modification
  • Inflammatory Bowel Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

0 Primary · 7 Secondary · Reporting Duration: At baseline versus within 6 days after 3rd cycle of IRCD and 3 months after 3rd cycle. 1 cycle of IRCD lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

Month 3
Effect of IRCD on patient quality of life: Short Inflammatory Bowel Disease questionnaire (SIBDQ)
Month 3
Number of Participants with Clinical remission as per CDAI
Number of Participants with Clinical response as per CDAI (100 points)
Number of Participants with Clinical response as per CDAI (70 points)
Day 6
Effect of IRCD on endoscopic outcomes
Number of Participants with Clinical remission as per Patient Reported Outcome (PRO) score
Patient global assessment
Day 6
Changes in clinical markers of disease activity
Month 3
Changes in gut metabolites (including short-chain fatty acid and bile acid profiles) and microbiome profiles (using 16S rRNA/shotgun metagenomics)
Day 6
Changes in cytokines/chemokines and immune cell profiles
Day 6
Change in C-reactive protein (CRP) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.
Change in Erythrocyte Sedimentation Rate (ESR) at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.
Change in fecal calprotectin at baseline versus after 3rd cycle of IRCD (or control at corresponding time point) in both IRCD and control group.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Interleukin-2 (aldesleukin).
3
Ozanimod
3
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Trial Design

2 Treatment Groups

Control Arm
1 of 2
Intervention Arm
1 of 2

Active Control

Experimental Treatment

75 Total Participants · 2 Treatment Groups

Primary Treatment: Intermittent Reduced Calorie Diet (IRCD) · No Placebo Group · N/A

Intervention Arm
Other
Experimental Group · 1 Intervention: Intermittent Reduced Calorie Diet (IRCD) · Intervention Types: Other
Control ArmNoIntervention Group · 1 Intervention: Control Arm · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline versus within 6 days after 3rd cycle of ircd and 3 months after 3rd cycle. 1 cycle of ircd lasts 5 days and is administered once a month, followed by regular diet for the rest of the month.

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,170 Previous Clinical Trials
35,768,208 Total Patients Enrolled
Sidhartha R Sinha, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
75 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a CDAI score between 151 and 450.
References

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