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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065048
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
University of California, Davis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Abigail Basson, Case Western Reserve University

Brief Summary:
This protocol is designed to compare the effectiveness of a dietary intervention for 7 days, given to patients with Crohn's disease (CD) in remission: a soy-based diet, which has been demonstrated to have numerous health benefits. The diet will be compared to participant 'baseline' (pre-diet) in terms of its ability to change the composition of gut bacteria and their production of butyrate, an important short chain fatty acid (SCFA) that limits bowel inflammation, a characteristic of this debilitating disease.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Soy based diet Not Applicable

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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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of Crohn's disease

    • Harvey Bradshaw Index (HBI) score <4 (indicating quiescent disease, remission)
    • Short Crohn's Disease Activity Index score (sCDAI) <150 (indicating quiescent disease, remission)
    • Signed written informed consent.
    • Able to receive food shipments delivered to a work or home environment.
    • Negative pregnancy test at screening visit in females of childbearing potential
    • Use of appropriate contraceptive methods for females of childbearing potential and males with procreative capacity during treatment
    • Stable medication use for ≥2 months at time of study enrolment, including but not limited to: steroids/corticosteroids, biologic therapy (infliximab, adalimumab, certolizumab pagol, golimumab, natalizumab, vedolizumab).
    • Able to take oral nutrition and medication intake for 6 months prior to and at time of study enrolment.

Exclusion Criteria:

  • Medical Exclusion:

    • Short bowel syndrome.
    • Hospitalized patients
    • Body mass Index <19 kg/m or ≥35.
    • Current smoker.
    • Harvey Bradshaw Index (HBI) >4 or a short Crohn's disease Activity Index (sCDAI) >150
    • Known clinically significant cardiovascular disease/conditions
    • Known clinically significant liver/gallbladder/pancreatic disease/dysfunction
    • Known allergy to soy, wheat, peanuts
    • Celiac disease
    • Serious secondary illnesses of an acute or chronic nature, which in the opinion of the Investigator renders the patient unsuitable for inclusion into the study.
    • Dementia.
    • Uncontrolled Diabetes Type I type II (fasting plasma glucose 7.0mM diabetics or pre-diabetics)
    • Known drug abuse.
    • Known parasitic disease of the digestive system.
    • HIV-infection.
    • Seizure disorder.
    • Presence of an ileal or colonic stoma.
    • Known previous or concurrent malignancy.
    • Anticipated need for surgery within 6 weeks
    • Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
    • Current use of hormonal or estrogen replacement therapies.
    • Documented C difficile colitis within four weeks of screening

Dietary Exclusion:

• Use of exclusively Soy-based diet within 4 weeks of screening

Medication Exclusion:

  • Other conditions that would be a contraindication to and of the study diets (e.g. allergy to soy, wheat, peanuts) or preclude the participant fron completing the study
  • Use of antibiotics within last 60 days.
  • Use of pre- or probiotics within last 60 days.
  • Start or change dose of IBD related medications within 8 weeks prior to enrollment: thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab, anti-TNF agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab Other
  • Well-founded doubt about the patient's cooperation.
  • Existing pregnancy, lactation, or intended pregnancy or impregnation within the next 3 months.

Information from the National Library of Medicine

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


Contacts
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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

Locations
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United States, Ohio
University Hospitals Digestive Health Institute Recruiting
Cleveland, Ohio, United States, 44106
Contact: Alicia DePlatchett, MBA    216-368-1674    aed76@case.edu   
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         
Sponsors and Collaborators
Case Western Reserve University
University of California, Davis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Fabio Cominelli, MD, PhD Case Western Reserve University, School of Medicine, Gastroenterology

Publications:
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Responsible Party: Abigail Basson, PostDoctoral Fellow, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT04065048    
Other Study ID Numbers: 09411
1P30DK097948 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Study results or individual subject results such as investigational tests will not be shared with the research participants or others unless deemed medically necessary. Result of this research and management of intellectual property will adherence to the NIH Grant Policy on Sharing of Unique Research Resources including the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources issued March 5, 2003.

Publication of data during the project and/or at the end of the project shall be consistent with normal scientific practices. Research data which documents, supports, and validates research findings will be made available after the main findings from the final research data set have been accepted for publication.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abigail Basson, Case Western Reserve University:
diet
inflammatory bowel disease
gut microbiome
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases