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

NCT04065048 | Completed Results DMC

• 2 other identifiers: 094111P30DK097948
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

diet; inflammatory bowel disease; gut microbiome

Outcome Measures

Primary Outcomes (2)

• Maintenance of Symptomatic Remission, Without Worsening of Any Existing Disease Activity During Study Period

  The primary aim will measure the Crohn's Disease Activity Index (CDAI) at the enrollment and end of study visit. CDAI scores can range from 0 to \~600 (A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease). Herein, a cut-off value of \<150 was selected so that most patients below this threshold would be rated by physicians as 'very well'. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point \[i.e., value at 7 days (post) minus value at baseline/enrollment (pre)\].

  7 days

• Change in Fecal Myleoperoxidase (MPO) Activity

  Change in fecal myleoperoxidase (MPO) activity at day 7 vs day 0.

  7 days

Secondary Outcomes (2)

• Changes to Functional Composition of Gut Microbiota

  measured after the 7-day diet intervention

• Percentage of Subjects Who Continue Diet Following Completion of Study

  6 months

Study Arms (2)

Soy-based diet

EXPERIMENTAL

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

Other: Soy based diet

Regular diet

ACTIVE COMPARATOR

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

Other: Non-soy based diet

Interventions

Soy based diet 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.

Soy-based diet

Non-soy based diet OTHER

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

Regular diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Western Reserve University: lead
• University of California, Davis: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals Digestive Health Institute

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

• 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.

  PMID: 21885731 BACKGROUND

• 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.

  PMID: 24336217 BACKGROUND

• 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.

  PMID: 20629100 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

The COVID pandemic posed a significant challenge that impeded the accrual of patients. The first participant was enrolled in 2019. However due to COVID, further participant enrollment only recommenced in 2021

Results Point of Contact

• Title: Abigail Raffner Basson, Principal Investigator & Study Coordinator
• Organization: Case Western Reserve University

axb860@case.edu

2163276003

Study Officials

• Fabio Cominelli, MD, PhD

  Case Western Reserve University, School of Medicine, Gastroenterology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PostDoctoral Fellow

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 22, 2019
• Study Start: November 1, 2019
• Primary Completion: September 11, 2023
• Study Completion: October 10, 2023
• Last Updated: December 17, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)