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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065048
• Other study ID #: 09411
• Secondary ID: 1P30DK097948
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 10, 2023

Study information

• Verified date: January 2024
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 10, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.
• Non-soy based diet
Diet of identical composition to the soy diet with the exception of soy.

Locations

Country	Name	City	State
United States	University Hospitals Digestive Health Institute	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University Hospitals Cleveland Medical Center, University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	measured after the 7-day diet intervention
Secondary	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.	measured after the 7-day diet intervention
Secondary	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).	6 months