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

January 26, 2024 updated by: Abigail Basson, Case Western Reserve University

A Single-center Open-label Study to Determine the Effect of Diet on Microbiome Signatures in Crohn's Disease Patients

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.

Study Overview

Status

Completed

Conditions

Detailed Description

The inflammatory bowel disease (IBD) subtype, Crohn's disease (CD) is a chronic and relapsing inflammatory disorder of the gastrointestinal tract. Although the precise etiology of IBD is not known, evidence suggests that environmental factors, including diet, contribute to its pathogenesis. A soy-based diet has been demonstrated to have numerous health benefits. This single-center open-label study will compare the effectiveness of a soy-based diet or an identical diet without soy to change the gut microbiota composition and fecal butyrate concentration to that of baseline (pre-diet) in patients with CD (remission or active disease) and healthy control subjects without CD. Participants will follow either a soy-based diet or an identical diet without soy to which they will be randomized for 7 days. No data collection or other study procedures will take place until the potential participant provides written informed consent to participate in the research study. The informed consent, screening, enrollment, and baseline data collection which make up visit 1 can occur on the same day or be completed across several days.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Digestive Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • CD subjects: Documented diagnosis of Crohn's disease. Control subjects: no documented diagnosis of CD.
  • CD subjects: Harvey Bradshaw Index (HBI) score <4 ('CD remission'), or with HBI score >8 ('CD moderate disease')
  • Capable of providing consent to participate
  • Access to technology that permits the daily completion of study related activities
  • Able to receive and have an adult sign for food shipments delivered to a work or home environment.
  • Negative pregnancy test at screening visit in females of childbearing potential
  • Able to take oral nutrition and medication intake for 3 months prior to and at time of study enrolment.
  • 'CD remission' subjects: No change in 'IBD related' medications within 8 weeks prior to normally scheduled appointment with treating gastroenterologist (pre-screening): biologics, immunosuppressants, corticosteroids.

Exclusion Criteria:

  • Short bowel syndrome.
  • Hospitalized patients
  • Body mass Index <19 kg/m or ≥35.
  • Known clinically significant liver/gallbladder/pancreatic disease/dysfunction
  • Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
  • Uncontrolled Diabetes Type I type II
  • Known drug abuse.
  • Known parasitic disease of the digestive system. symptomatic intestinal stricture.
  • Presence of an ostomy.
  • Known concurrent malignancy.
  • Other conditions that would be a contraindication to and of the study diets (e.g. Soy, peanut, wheat, gluten allergy.) or preclude the participant from completing the study
  • Start of new 'IBD related' medications within 8 weeks prior to enrollment: biologics, immunosuppressants, corticosteroids.
  • Documented C difficile colitis within four weeks of screening
  • Well-founded doubt about the patient's cooperation.
  • Existing pregnancy or lactation.
  • Current participation in another diet intervention, simultaneous participation in another clinical trial, or participation in any other dietary intervention trial within the last 30 days.
  • History of <3 natural bowel movements per week.
  • Unable to access to technology that permits the daily completion of study related activities.
  • Currently consuming a soy-based diet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soy-based diet
Participants will be randomized to follow a soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
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.
Active Comparator: Regular diet
Participants will be randomized to follow a diet without soy for 7 days. The diet will be preceded by a 12-hr overnight fast.
Diet of identical composition to the soy diet with the exception of soy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of Symptomatic Remission, without worsening of any existing disease activity during study period
Time Frame: measured after the 7-day diet intervention
The primary aim will focus on maintaining quiescent disease status, without worsening of any existing disease activity of the patient with Crohn's disease (CD) before/after diet intervention. This will be measured at the enrollment and end of study visits using the Crohn's Disease Activity Index (CDAI). Fecal myleoperoxidase will also be assessed.
measured after the 7-day diet intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes to Functional Composition of Gut Microbiota
Time Frame: measured after the 7-day diet intervention
Secondary outcome will focus on changes to the functional composition of fecal gut microbiota, including bacterial butryate production after the diet intervention.
measured after the 7-day diet intervention
Proportion of subjects who continue diet following completion of study
Time Frame: 6 months
To assess the proportion of patients who intend to continue the study diets when prepared food is no longer provided without cost, and the reasons for discontinuation of either diet (compared to resuming usual food habits).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fabio Cominelli, MD, PhD, Case Western Reserve University, School of Medicine, Gastroenterology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

September 11, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 09411
  • 1P30DK097948 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study results or individual subject results such as investigational tests will not be shared with the research participants or others unless deemed medically necessary. Result of this research and management of intellectual property will adherence to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources issued March 5, 2003.

Publication of data during the project and/or at the end of the project shall be consistent with normal scientific practices. Research data which documents, supports, and validates research findings will be made available after the main findings from the final research data set have been accepted for publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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