- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065048
A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients
A Single-center Open-label Study to Determine the Effect of Diet on Microbiome Signatures in Crohn's Disease Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abigail Basson, PhD, RD, LD
- Phone Number: 1-888-844-8447
- Email: Abigail.Basson@uhhospitals.org
Study Contact Backup
- Name: Jeffry Katz, MD
- Phone Number: 1-888-844-8447
- Email: Jeffry.Katz@uhhospitals.org
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Digestive Health Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- CD subjects: Documented diagnosis of Crohn's disease. Control subjects: no documented diagnosis of CD.
- CD subjects: Harvey Bradshaw Index (HBI) score <4 ('CD remission'), or with HBI score >8 ('CD moderate disease')
- Capable of providing consent to participate
- Access to technology that permits the daily completion of study related activities
- Able to receive and have an adult sign for food shipments delivered to a work or home environment.
- Negative pregnancy test at screening visit in females of childbearing potential
- Able to take oral nutrition and medication intake for 3 months prior to and at time of study enrolment.
- 'CD remission' subjects: No change in 'IBD related' medications within 8 weeks prior to normally scheduled appointment with treating gastroenterologist (pre-screening): biologics, immunosuppressants, corticosteroids.
Exclusion Criteria:
- Short bowel syndrome.
- Hospitalized patients
- Body mass Index <19 kg/m or ≥35.
- Known clinically significant liver/gallbladder/pancreatic disease/dysfunction
- Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
- Uncontrolled Diabetes Type I type II
- Known drug abuse.
- Known parasitic disease of the digestive system. symptomatic intestinal stricture.
- Presence of an ostomy.
- Known concurrent malignancy.
- Other conditions that would be a contraindication to and of the study diets (e.g. Soy, peanut, wheat, gluten allergy.) or preclude the participant from completing the study
- Start of new 'IBD related' medications within 8 weeks prior to enrollment: biologics, immunosuppressants, corticosteroids.
- Documented C difficile colitis within four weeks of screening
- Well-founded doubt about the patient's cooperation.
- Existing pregnancy or lactation.
- Current participation in another diet intervention, simultaneous participation in another clinical trial, or participation in any other dietary intervention trial within the last 30 days.
- History of <3 natural bowel movements per week.
- Unable to access to technology that permits the daily completion of study related activities.
- Currently consuming a soy-based diet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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Diet of identical composition to the soy diet with the exception of soy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintenance of Symptomatic Remission, without worsening of any existing disease activity during study period
Time Frame: measured after the 7-day diet intervention
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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.
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measured after the 7-day diet intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes to Functional Composition of Gut Microbiota
Time Frame: measured after the 7-day diet intervention
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Secondary outcome will focus on changes to the functional composition of fecal gut microbiota, including bacterial butryate production after the diet intervention.
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measured after the 7-day diet intervention
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Proportion of subjects who continue diet following completion of study
Time Frame: 6 months
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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).
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Fabio Cominelli, MD, PhD, Case Western Reserve University, School of Medicine, Gastroenterology
Publications and helpful links
General Publications
- David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
- Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
- Thia K, Faubion WA Jr, Loftus EV Jr, Persson T, Persson A, Sandborn WJ. Short CDAI: development and validation of a shortened and simplified Crohn's disease activity index. Inflamm Bowel Dis. 2011 Jan;17(1):105-11. doi: 10.1002/ibd.21400.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09411
- 1P30DK097948 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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