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

  • End date
    May 30, 2023
  • participants needed
  • sponsor
    Case Western Reserve University
Updated on 20 October 2022
crohn's disease
certolizumab pegol


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.


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.

Condition Crohn Disease
Treatment Soy based diet, Non-soy based diet
Clinical Study IdentifierNCT04065048
SponsorCase Western Reserve University
Last Modified on20 October 2022


Yes No Not Sure

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

Body mass Index <19 kg/m or ≥35
Short bowel syndrome
Hospitalized patients
Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients
Uncontrolled Diabetes Type I type II
Known parasitic disease of the digestive system. symptomatic intestinal stricture
Known clinically significant liver/gallbladder/pancreatic disease/dysfunction
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
Existing pregnancy or lactation
Known drug abuse
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
Documented C difficile colitis within four weeks of screening
Well-founded doubt about the patient's cooperation
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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