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 : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Other: Soy based diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open label single center study to compare the effect of a soy-based diet on the composition and metabolite (butyrate) production of gut bacteria in Crohn's disease in remission. Participants will be pre-screened by the treating gastroenterologist for eligibility criteria (HBI <4, stable medication therapy ≥ 2 months) 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. Participants 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 :||October 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
Crohn's disease patients in remission
Crohn's disease patients will follow an identical diet intervention protocol therefore no randomization will be performed after enrollment. Participants will follow a soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast and will be immediately followed by a wash out period for a minimum of 7 days and no longer than 14 days.
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.
- Maintenance of Symptomatic Remission [ Time Frame: measured after the 7-day diet intervention ]Primary aim will focus on maintaining quiescent disease status 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 Crohn's Disease Activity Index (CDAI). The CDAI includes: liquid stools (# in past 7 days; x 2), abdominal pain (0=none, 1=mild, 2=moderate, 3=severe; x 5), general health (0=well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible; x 7), extraintestinal complaints (presence=1 per complaint: arthritis/arthralgia, mucocutaneous lesions, ocular symptoms, external fistula, or temperature >37.8C; x 20), antidiarrheal drug use in past 7 days (0=no, 1=yes; x 30), abdominal mass (0=questionable, 2=questionable, 5=definite; multiplier x 10), hematocrit (expected-measured; x 6), and body weight (Ideal-measured/ideal x100; x 1). The sum of each of the variables (x multiplier listed) is the "CDAI score" with a higher score indicating more severe CD.
- 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.
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|