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

Completed · Not applicable

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT04065048

Run by

Case Western Reserve University

People needed

67

Starts

2019-11-01

Expected to finish

2023-10-10

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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