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

NCT ID: NCT04065048

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-10-10

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.

Conditions

Crohn Disease

Keywords

diet; inflammatory bowel disease; gut microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Soy based diet

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Non-soy based diet

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Non-soy based diet

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Abigail Basson

PostDoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabio Cominelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, School of Medicine, Gastroenterology

Locations

University Hospitals Digestive Health Institute

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21885731 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24336217 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20629100 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1P30DK097948

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09411

Identifier Type: -

Identifier Source: org_study_id