A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients
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|ClinicalTrials.gov Identifier: NCT04065048|
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : October 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Other: Soy based diet Other: Non-soy based diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an open label single center study to compare the effect of a soy-based diet or an identical diet without soy on the composition and metabolite production of gut bacteria in Crohn's disease (CD) patients in remission or active disease, and in healthy controls. Crohn's subjects will be pre-screened by the treating gastroenterologist for eligibility criteria during their normally scheduled appointment. The treating gastroenterologist will ask suitable patients whether they are interested in participating in the described dietary intervention study during the patient appointment. Initial verbal consent will be obtained by the treating gastroenterologist. Healthy controls will be recruited in the same manner, as well as via a hospital flyer advertisement. Subjects will then be contacted by the study investigator to schedule a screening visit (visit 1) and if study eligibility is confirmed, and informed consent provided, enrolled into the study.|
|Masking:||None (Open Label)|
|Official Title:||A Single-center Open-label Study to Determine the Effect of Diet on Microbiome Signatures in Crohn's Disease Patients|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Soy-based diet
Participants will be randomized to follow a soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.
Other: Soy based diet
The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
Active Comparator: Regular diet
Participants will be randomized to follow a diet without soy for 7 days. The diet will be preceded by a 12-hr overnight fast.
Other: Non-soy based diet
Diet of identical composition to the soy diet with the exception of soy.
- Maintenance of Symptomatic Remission, without worsening of any existing disease activity during study period [ Time Frame: measured after the 7-day diet intervention ]The primary aim will focus on maintaining quiescent disease status, without worsening of any existing disease activity of the patient with Crohn's disease (CD) before/after diet intervention. This will be measured at the enrollment and end of study visits using the Crohn's Disease Activity Index (CDAI). Fecal myleoperoxidase will also be assessed.
- Changes to Functional Composition of Gut Microbiota [ Time Frame: measured after the 7-day diet intervention ]Secondary outcome will focus on changes to the functional composition of fecal gut microbiota, including bacterial butryate production after the diet intervention.
- Proportion of subjects who continue diet following completion of study [ Time Frame: 6 months ]To assess the proportion 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065048
|Contact: Abigail Basson, PhD, RD, LD||1-888-844-8447||Abigail.Basson@uhhospitals.org|
|Contact: Jeffry Katz, MD||1-888-844-8447||Jeffry.Katz@uhhospitals.org|
|United States, Ohio|
|University Hospitals Digestive Health Institute||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Alicia DePlatchett, MBA 216-368-1674 firstname.lastname@example.org|
|Contact: Steve Myers, MBA 219-844-7324 Steven.Myers2@uhhospitals.org|
|Sub-Investigator: Jeffry Katz, MD|
|Sub-Investigator: Preetika Sinh, MD|
|Principal Investigator: Fabio Cominelli, MD, PhD|
|Principal Investigator:||Fabio Cominelli, MD, PhD||Case Western Reserve University, School of Medicine, Gastroenterology|