Status:
COMPLETED
A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
University of California, Davis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Crohn Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
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 c...
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, ev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04065048
Start Date
November 1 2019
End Date
October 10 2023
Last Update
December 17 2024
Active Locations (1)
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1
University Hospitals Digestive Health Institute
Cleveland, Ohio, United States, 44106