A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients
N/A
Completed
NCT04065048
| Condition | Crohn Disease |
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| Phase | N/A |
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| Sponsor | Case Western Reserve University |
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| Status | Completed |
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| Enrollment | 67 participants |
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| Interventions | Soy based diet, Non-soy based diet |
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| Start date | Nov 1, 2019 |
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| Completion date | Sep 11, 2023 |
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| Results posted | Sep 19, 2024 |
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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.
Maintenance of Symptomatic Remission, Without Worsening of Any Existing Disease Activity During Study Period
7 days · score on a scale
| Crohn's Patients on Soy Diet | -31.63 ± 57.91 score on a scale |
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| Crohn's Patients on Non-soy Diet | -27.57 ± 56.62 score on a scale |
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Change in Fecal Myleoperoxidase (MPO) Activity
7 days · ug/mg
| Crohn's on Soy Diet | -0.891 ± 1.471 ug/mg |
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| Crohn's on Non-Soy Diet | 0.7336 ± 1.483 ug/mg |
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| Healthy Controls on Soy Diet | -0.0995 ± 0.767 ug/mg |
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| Healthy Controls on Non-Soy Diet | 0.5209 ± 1.036 ug/mg |
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Open in BENITIONS
View on ClinicalTrials.gov
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