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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04065048
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : November 15, 2022
University of California, Davis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Abigail Basson, Case Western Reserve University

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Soy based diet Other: Non-soy based diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an open label single center study to compare the effect of a soy-based diet or an identical diet without soy on the composition and metabolite production of gut bacteria in Crohn's disease (CD) patients in remission or active disease, and in healthy controls. Crohn's subjects will be pre-screened by the treating gastroenterologist for eligibility criteria during their normally scheduled appointment. The treating gastroenterologist will ask suitable patients whether they are interested in participating in the described dietary intervention study during the patient appointment. Initial verbal consent will be obtained by the treating gastroenterologist. Healthy controls will be recruited in the same manner, as well as via a hospital flyer advertisement. Subjects will then be contacted by the study investigator to schedule a screening visit (visit 1) and if study eligibility is confirmed, and informed consent provided, enrolled into the study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-center Open-label Study to Determine the Effect of Diet on Microbiome Signatures in Crohn's Disease Patients
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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.
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.

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.
Other: Non-soy based diet
Diet of identical composition to the soy diet with the exception of soy.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065048

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Contact: Abigail Basson, PhD, RD, LD 1-888-844-8447 Abigail.Basson@uhhospitals.org
Contact: Jeffry Katz, MD 1-888-844-8447 Jeffry.Katz@uhhospitals.org

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United States, Ohio
University Hospitals Digestive Health Institute Recruiting
Cleveland, Ohio, United States, 44106
Contact: Tracy Krebs, BS    216-368-6058    tls23@case.edu   
Contact: Steve Myers, MBA    219-844-7324    Steven.Myers2@uhhospitals.org   
Sub-Investigator: Jeffry Katz, MD         
Sub-Investigator: Preetika Sinh, MD         
Principal Investigator: Fabio Cominelli, MD, PhD         
Sponsors and Collaborators
Case Western Reserve University
University of California, Davis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University Hospitals Cleveland Medical Center
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Principal Investigator: Fabio Cominelli, MD, PhD Case Western Reserve University, School of Medicine, Gastroenterology
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Responsible Party: Abigail Basson, PostDoctoral Fellow, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT04065048    
Other Study ID Numbers: 09411
1P30DK097948 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abigail Basson, Case Western Reserve University:
inflammatory bowel disease
gut microbiome
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases