The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)

NCT04757181 | Completed

• 1 other identifier: H00008033
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to prospectively test the hypothesis that specific dietary modification can improve patient symptoms by promoting beneficial changes in the composition of the microbiome that, in turn, alter the immune response in such a way as to and ameliorate inflammatory conditions such as Inflammatory Bowel Disease (IBD). The potential long term benefit of this research is a validated set of efficacious dietary guidelines for persons with IBD. The potential immediate benefit to patients is symptomatic relief and healing.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Microbiome change after the IBD-AID

  Analysis of the microbial composition of the gut and changes that correlate with diet compliance

  8 weeks

Secondary Outcomes (2)

• Improvement of symptoms

  8 weeks

• Improvement of inflammatory markers

  8 weeks

Study Arms (1)

IBD patients

EXPERIMENTAL

IBD patients will be used as their own control. Participants will start the study in a baseline phase (4 weeks) and intervention phase (8 weeks)

Other: The IBD-AID

Interventions

The IBD-AID OTHER

Subjects will meet with study personnel for to fill out baseline questionnaires (approximately a 1-hour visit). Subjects will be instructed to make dietary changes based one the IBD-AID guidelines. Dietary instruction will be delivered via individual and group sessions led by trained study personnel. Participants will be expected to learn the skills of dietary change to the IBD-AID and will begin their 8 weeks compliance period followed by endpoint measures. Participants are encouraged to attend 3 cooking classes (1.5 hours duration) in our teaching kitchen.

IBD patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 15 years of age or older
• Willingness and capacity to significantly change diet
• Willing and able to comply with scheduled visits, blood, and stool collection, and other study procedures and to complete the study
• Clinical provider (GI clinician) permission for IBD patients to participate in the intervention is required for participation in the study.
• Evidence of personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• For children age 15 and above, the assent of the child and consent of a parent or legal guardian will be required.
• One of the following:
• diagnosis of IBD, specifically Crohn's Disease and Ulcerative Colitis
• healthy control

You may not qualify if:

• the presence of infection (such as C.diff) precipitating the colitis
• antibiotics taken within 3 months of study entry
• medically unstable to give consent
• on heparin or Coumadin
• Prisoners
• Subjects who do not speak or understand English, to ensure that there is consistency in teaching and educational materials.
• Subjects who self-report current pregnancy
• Patients who do not receive clinical care at UMass Memorial Health Care

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study design is a single-arm, prospective, pre-post intervention trial.

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 17, 2021
• Study Start: February 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)