N/A
Completed N=67
A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients
Crohn Disease
Source: ClinicalTrials.gov NCT04065048 ↗
Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Maintenance of Symptomatic Remission, Without Worsening of Any Existing Disease Activity During Study Period — -31.63; -27.57 score on a scale — p=0.469
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maintenance of Symptomatic Remission, Without Worsening of Any Existing Disease Activity During Study Period |
-31.63; -27.57 | 0.469 |
| PRIMARY Change in Fecal Myleoperoxidase (MPO) Activity |
-0.891; 0.7336; -0.0995; 0.5209 | 0.0093 sig |
| SECONDARY Changes to Functional Composition of Gut Microbiota |
0.02046; 0.009773; 0.01436; 0.01865 | — |
| SECONDARY Percentage of Subjects Who Continue Diet Following Completion of Study |
8; 5; 4; 1 | 0.2487 |
Eligibility Criteria
Inclusion Criteria
- CD subjects: Documented diagnosis of Crohn's disease. Control subjects: no documented diagnosis of CD.
- CD subjects: Harvey Bradshaw Index (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
Data sourced from ClinicalTrials.gov (NCT04065048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.