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A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients

NCT04065048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-12-17

Study results available
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Summary

This protocol is designed to compare the effectiveness of a soy-based diet or identical diet without soy given to patients with Crohn's disease (CD) in remission, patients with active CD, or healthy controls. The assigned diet will be compared to participant 'baseline' (pre-diet) in terms of its ability to change the gut bacteria and fecal butyrate, an important short-chain fatty acid (SCFA) that limits bowel inflammation, a characteristic of this debilitating disease.

Conditions

  • Crohn Disease

Interventions

OTHER

Soy based diet

The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.

OTHER

Non-soy based diet

Diet of identical composition to the soy diet with the exception of soy.

Sponsors & Collaborators

  • University of California, Davis

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Fabio Cominelli, MD, PhD · Case Western Reserve University, School of Medicine, Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2023-09-11
Completion
2023-10-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04065048 on ClinicalTrials.gov