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

Case Western Reserve University

Status

Completed

Conditions

Crohn Disease

Treatments

Other: Soy based diet

Other: Non-soy based diet

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04065048

09411

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

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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