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

Primary Purpose

Crohn Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Soy based diet

Non-soy based diet

About this trial

This is an interventional other trial for Crohn Disease focused on measuring diet, inflammatory bowel disease, gut microbiome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospitals Digestive Health InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Soy-based diet

Regular diet

Arm Description

Participants will be randomized to follow a soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.

Participants will be randomized to follow a diet without soy for 7 days. The diet will be preceded by a 12-hr overnight fast.

Outcomes

Primary Outcome Measures

Maintenance of Symptomatic Remission, without worsening of any existing disease activity during study period

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.

Secondary Outcome Measures

Changes to Functional Composition of Gut Microbiota

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

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).

Full Information

NCT ID

NCT04065048

First Posted

August 19, 2019

Last Updated

November 14, 2022

Sponsor

Case Western Reserve University

Collaborators

University of California, Davis, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University Hospitals Cleveland Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04065048

Brief Title

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

Official Title

A Single-center Open-label Study to Determine the Effect of Diet on Microbiome Signatures in Crohn's Disease Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Case Western Reserve University

Collaborators

University of California, Davis, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

The inflammatory bowel disease (IBD) subtype, Crohn's disease (CD) is a chronic and relapsing inflammatory disorder of the gastrointestinal tract. Although the precise etiology of IBD is not known, evidence suggests that environmental factors, including diet, contribute to its pathogenesis. A soy-based diet has been demonstrated to have numerous health benefits. This single-center open-label study will compare the effectiveness of a soy-based diet or an identical diet without soy to change the gut microbiota composition and fecal butyrate concentration to that of baseline (pre-diet) in patients with CD (remission or active disease) and healthy control subjects without CD. Participants will follow either a soy-based diet or an identical diet without soy to which they will be randomized for 7 days. No data collection or other study procedures will take place until the potential participant provides written informed consent to participate in the research study. The informed consent, screening, enrollment, and baseline data collection which make up visit 1 can occur on the same day or be completed across several days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

diet, inflammatory bowel disease, gut microbiome

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Soy-based diet

Arm Type

Experimental

Arm Description

Participants will be randomized to follow a soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast.

Arm Title

Regular diet

Arm Type

Active Comparator

Arm Description

Participants will be randomized to follow a diet without soy for 7 days. The diet will be preceded by a 12-hr overnight fast.

Intervention Type

Other

Intervention Name(s)

Soy based diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Non-soy based diet

Intervention Description

Diet of identical composition to the soy diet with the exception of soy.

Primary Outcome Measure Information:

Title

Maintenance of Symptomatic Remission, without worsening of any existing disease activity during study period

Description

Time Frame

measured after the 7-day diet intervention

Secondary Outcome Measure Information:

Title

Changes to Functional Composition of Gut Microbiota

Description

Secondary outcome will focus on changes to the functional composition of fecal gut microbiota, including bacterial butryate production after the diet intervention.

Time Frame

measured after the 7-day diet intervention

Title

Proportion of subjects who continue diet following completion of study

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abigail Basson, PhD, RD, LD

Phone

1-888-844-8447

Abigail.Basson@uhhospitals.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffry Katz, MD

Phone

1-888-844-8447

Jeffry.Katz@uhhospitals.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabio Cominelli, MD, PhD

Organizational Affiliation

Case Western Reserve University, School of Medicine, Gastroenterology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospitals Digestive Health Institute

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tracy Krebs, BS

Phone

216-368-6058

tls23@case.edu

First Name & Middle Initial & Last Name & Degree

Steve Myers, MBA

Phone

219-844-7324

Steven.Myers2@uhhospitals.org

First Name & Middle Initial & Last Name & Degree

Jeffry Katz, MD

First Name & Middle Initial & Last Name & Degree

Preetika Sinh, MD

First Name & Middle Initial & Last Name & Degree

Fabio Cominelli, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Citations:

PubMed Identifier

21885731

Citation

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.

Results Reference

background

PubMed Identifier

24336217

Citation

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.

Results Reference

background

PubMed Identifier

20629100

Citation

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.

Results Reference

background

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

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