BENITIONSClinical Trial Intelligence

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

단계 해당 없음 완료 NCT04065048

대상 질환Crohn Disease
임상 단계단계 해당 없음
스폰서Case Western Reserve University
상태완료
참여자 수67 명
중재(약물)Soy based diet, Non-soy based diet
시작일2019년 11월 1일
완료일2023년 9월 11일
결과 공개일2024년 9월 19일

요약

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
Crohn's Patients on Non-soy Diet-27.57 ± 56.62 score on a scale
p-value0.469

Change in Fecal Myleoperoxidase (MPO) Activity

7 days · ug/mg

Crohn's on Soy Diet-0.891 ± 1.471 ug/mg
Crohn's on Non-Soy Diet0.7336 ± 1.483 ug/mg
Healthy Controls on Soy Diet-0.0995 ± 0.767 ug/mg
Healthy Controls on Non-Soy Diet0.5209 ± 1.036 ug/mg
p-value0.0093

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