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Soy-Based Diet for Crohn's Disease

N/A

Waitlist Available

Led By Fabio Cominelli, MD, PhD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will compare the effectiveness of a soy-based diet to an identical diet without soy for people with Crohn's disease or healthy controls.

Who is the study for?

This trial is for adults with Crohn's disease, either in remission or with moderate disease activity, and healthy individuals as controls. Participants must not have had recent medication changes, be able to take oral nutrition and medications, and commit to daily study tasks using technology. Pregnant women, those on a current soy-based diet, or with certain health conditions like uncontrolled diabetes are excluded.Check my eligibility

What is being tested?

The study tests the effects of a soy-based diet versus a non-soy based diet on gut bacteria and fecal butyrate levels in people with Crohn's disease compared to their own pre-diet baseline. The goal is to see if these diets can reduce bowel inflammation associated with Crohn's.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort or allergic reactions related to dietary components such as soy. Changes in gut microbiome could also affect bowel habits temporarily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maintenance of Symptomatic Remission, without worsening of any existing disease activity during study period

Secondary outcome measures

Changes to Functional Composition of Gut Microbiota

Proportion of subjects who continue diet following completion of study

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Soy-based dietExperimental Treatment1 Intervention

Participants will be randomized to follow a soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.

Group II: Regular dietActive Control1 Intervention

Participants will be randomized to follow a diet without soy for 7 days. The diet will be preceded by a 12-hr overnight fast.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

2,357 Previous Clinical Trials

4,315,119 Total Patients Enrolled

University Hospitals Cleveland Medical CenterOTHER

317 Previous Clinical Trials

340,190 Total Patients Enrolled

University of California, DavisOTHER

910 Previous Clinical Trials

4,706,924 Total Patients Enrolled

Media Library

Soy based diet Clinical Trial Eligibility Overview. Trial Name: NCT04065048 — N/A

Crohn's Disease Research Study Groups: Soy-based diet, Regular diet

Crohn's Disease Clinical Trial 2023: Soy based diet Highlights & Side Effects. Trial Name: NCT04065048 — N/A

Soy based diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04065048 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this experiment greater than 80 years old?

"According to the study criteria, the minimum age for participation is 18 and elderly patients up to 65 years old are welcome."

Answered by AI

Is enrolment for this research project currently open?

"Affirmative. The clinicaltrials.gov database confirms that, beginning November 1st 2019, this trial is still actively enrolling participants. 60 patients are required to be screened at a single location."

Answered by AI

What is the aggregate of participants enrolled in this medical experiment?

"Yes, the details published on clinicaltrials.gov demonstrate that this trial is currently seeking participants. The study was first listed on November 1st 2019 and has been recently updated in November 2022. 60 patients must be enrolled across a single medical centre to complete enrollment requirements."

Answered by AI

Is the opportunity to partake in this investigation open to me?

"This scientific project is looking to recruit 60 individuals aged between 18 and 65 with ileocolitis. Additional qualifications for these patients include being able to receive food deliveries, passing a pregnancy test (if applicable), having 3 months of unimpeded oral nutrition/medication intake prior to enrolment, current Crohn's disease diagnosis or remission status depending on the subject group, demonstrated capability in providing consent as well as access to technology that supports daily study-related activities."

Answered by AI

Recent research and studies

Inflammatory Bowel DiseasesJournal

Short CDAI: Development and Validation of a Shortened and Simplified Crohnʼs Disease Activity Index

Thia, Kelvin, William A. Faubion Jr, Edward V. Loftus Jr, Tore Persson, Anders Persson, and William J. Sandborn. 2011. “Short CDAI: Development and Validation of a Shortened and Simplified Crohnʼs Disease Activity Index”. Inflammatory Bowel Diseases. Oxford University Press (OUP). doi:10.1002/ibd.21400.

ScienceJournal

Linking Long-term Dietary Patterns with Gut Microbial Enterotypes

Wu, Gary D., Jun Chen, Christian Hoffmann, Kyle Bittinger, Ying-Yu Chen, Sue A. Keilbaugh, Meenakshi Bewtra, et al.. 2011. “Linking Long-term Dietary Patterns with Gut Microbial Enterotypes”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.1208344.

NatureJournal

Diet Rapidly and Reproducibly Alters the Human Gut Microbiome

David, Lawrence A., Corinne F. Maurice, Rachel N. Carmody, David B. Gootenberg, Julie E. Button, Benjamin E. Wolfe, Alisha V. Ling, et al.. 2013. “Diet Rapidly and Reproducibly Alters the Human Gut Microbiome”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature12820.

clinicaltrials.govStudy