RECRUITING

Changes in Microbiota and Quality of Life in IBS

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Conditions

IBS - Irritable Bowel Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary research question to be addressed is: Does a 2'-FL-containing dietary supplement impact stool microbiota composition in adults with IBS? The primary measure for determining potential impacts of the 2'-FL-containing dietary supplement on stool microbiota composition is stool abundance of Faecalibacterium prausnitzii, a commensal intestinal bacteria. Additional measures related to determining potential impacts of the 2'-FL-containing dietary supplement on gut microbiota composition are stool levels of additional commensal intestinal bacteria and measures of intestinal microbial diversity.

Official Title

Evaluating Changes in Microbiota Composition and Quality of Life in Irritable Bowel Syndrome: A Randomized, Controlled Trial

Quick Facts

Study Start:2022-04-01
Study Completion:2024-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05266287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults age 18-70 years (inclusive)
  2. * Existing diagnosis of IBS
  3. * Willing to take the 2'-FL-containing dietary supplement (or a control supplement) three times per day for 6 weeks
  4. * Willing to attend 4 in-person study visits
  5. * Willing to collect 3 stool samples at home
  6. * Willing to periodically monitor stool form/consistency (and log the information on a diary)
  7. * Willing to complete IBS symptom focused questionnaires
  8. * Willing to refrain from making changes in dietary supplements and medications for the duration of the study
  9. * Willing to maintain current dietary pattern for the duration of the study
  10. * Willing to maintain current exercise pattern for the duration of the study
  11. * Able to speak, read, and understand the English language
  12. * Able to provide written informed consent
  1. * Do not have an active primary care provider or specialist managing their IBS
  2. * Initiation of or changes to supplements or medications within 2 weeks prior to screening and/or enrollment (changes include stopping or changing the dose of supplements or medications)
  3. * Intake of prebiotic or fiber supplement(s) (current intake or intake within 2 weeks prior to screening and/or enrollment)
  4. * Intake of probiotic supplement(s) (current intake or intake within 2 weeks prior to screening and/or enrollment)
  5. * Use of antibiotic, antiparasitic, or antifungal medications orally or intravenously (current use or use within 2 weeks prior to screening and/or enrollment)
  6. * Initiation of or changes to an exercise regimen within 2 weeks prior to screening and/or enrollment
  7. * Initiation of or changes to a food plan within 2 weeks prior to screening and/or enrollment
  8. * Current involvement or within 2 weeks prior to screening and/or enrollment of a significant diet or weight loss program (such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet programs) or very low-calorie liquid diet programs (such as Optifast, Medifast, and/or HMR)
  9. * Current or previous history of chronic gastrointestinal illness other than IBS (e.g. inflammatory bowel disease, celiac disease, diverticulitis, cirrhosis, hepatitis, etc.)
  10. * History of gastrointestinal surgery other than appendectomy (e.g. weight loss surgery, cholecystectomy, splenectomy, etc.)
  11. * Major medical or surgical event requiring hospitalization (for any reason other than a minor scheduled medical procedure) within 3 months prior to screening
  12. * Cancer diagnosis or treatment within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)
  13. * Currently participating in another interventional research study or participated in another interventional study within 2 weeks prior to screening
  14. * Known intolerance or allergy to ingredients that may be in the study supplement or control supplement (Collinsonia root, beet root, okra, date powder, sucanat, rice hull concentrate, rice bran extract, cellulose, calcium stearate, calcium phosphate, gum arabic, or a trace amount of lactose)
  15. * Women who are lactating, pregnant or planning pregnancy within the next 3 months

Contacts and Locations

Study Contact

Anders Gundersen, MS
CONTACT
503-552-1752
agundersen@nunm.edu

Principal Investigator

Ryan Bradley, ND, MPH
PRINCIPAL_INVESTIGATOR
National University of Natural Medicine

Study Locations (Sites)

National University of Natural Medicine
Portland, Oregon, 97201
United States

Collaborators and Investigators

Sponsor: National University of Natural Medicine

  • Ryan Bradley, ND, MPH, PRINCIPAL_INVESTIGATOR, National University of Natural Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2024-03-15

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2024-03-15

Terms related to this study

Additional Relevant MeSH Terms

  • IBS - Irritable Bowel Syndrome