NCT04065048

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

Completed NA Results posted Last updated 17 December 2024

What this trial tests

NA trial testing Soy based diet in Crohn Disease in 67 participants. Completed in 10 October 2023.

Timeline

1 November 2019

Primary endpoint
11 September 2023

10 October 2023

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	67
Start date	1 November 2019
Primary completion	11 September 2023
Estimated completion	10 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Soy based diet
• Non-soy based diet

Conditions studied

• Crohn Disease — all drugs for Crohn Disease →

Sponsor

Case Western Reserve University

Who can join

Adults 18 to 65, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maintenance of Symptomatic Remission, Without Worsening of Any Existing Disease Activity During Study Period Primary · 7 days

The primary aim will measure the Crohn's Disease Activity Index (CDAI) at the enrollment and end of study visit. CDAI scores can range from 0 to \~600 (A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease). Herein, a cut-off value of \<150 was selected so that most patients below this threshold would be rated by physicians as 'very well'. Change was calculated from two time points as the value at the later time point minus the value at the earlier time poin

Group	Value	95% CI
Crohn's Patients on Soy Diet	-31.63	± 57.91
Crohn's Patients on Non-soy Diet	-27.57	± 56.62

Change in Fecal Myleoperoxidase (MPO) Activity Primary · 7 days

Change in fecal myleoperoxidase (MPO) activity at day 7 vs day 0.

Group	Value	95% CI
Crohn's on Soy Diet	-0.691	± 1.471
Crohn's on Non-Soy Diet	0.7336	± 1.483
Healthy Controls on Soy Diet	-0.0995	± 0.767
Healthy Controls on Non-Soy Diet	0.5209	± 1.036

Percentage of Subjects Who Continue Diet Following Completion of Study Secondary · 6 months

To assess the percentage of patients who intend to continue the study diets when prepared food is no longer provided without cost, and the reasons for discontinuation of either diet (compared to resuming usual food habits).

Group	Value	95% CI
Crohn's Participants on Soy Diet	8
Crohn's Patients on Non-Soy Diet	5
Healthy Control Participants on Soy Diet	4
Healthy Participants on Non-soy Diet	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected over the 7 day diet intervention period. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Crohn's on Soy Diet

Serious: 0/16 (0%)

Deaths: 0/16

Crohn's on Non-Soy Diet

Serious: 0/15 (0%)

Deaths: 0/15

Healthy Controls on Soy Diet

Serious: 0/14 (0%)

Deaths: 0/14

Healthy Controls on Non-Soy Diet

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	Crohn's on Soy Diet	Crohn's on Non-Soy Diet	Healthy Controls on Soy Diet	Healthy Controls on Non-So…
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04065048 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel technologies to characterize and engineer the microbiome in inflammatory bowel disease.
   Boix-Amorós A, Monaco H, Sambataro E, Clemente JC. · · 2022 · cited 10× · PMID 36104776 · DOI 10.1080/19490976.2022.2107866
2. A Randomized Controlled Trial Comparing Soy-Pea Protein to Animal Protein in Adults with Crohn’s Disease
   Basson AR, Katz J, Nguyen V, Singh D, et al · · 2026 · DOI 10.64898/2026.05.20.26353678
3. Dietary Trends in Crohn's Disease: A Comparison with Healthy Controls.
   Devorkin B, Cominelli F, Basson AR. · · 2025 · PMID 40852193 · DOI 10.29011/2577-2201.100267