Recruiting

Microbiota & Quality of LifeChanges in Microbiota and Quality of Life in IBS

Sponsor:

National University of Natural Medicine

Code:

NCT05266287

Conditions

IBS - Irritable Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

a supplement containing 2'-fucosyllactose (2'-FL)

Placebo Supplement

Study Details

Brief summary:

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.

Conditions

IBS - Irritable Bowel Syndrome

Study ID

NCT05266287

Start date

Apr 1, 2022

Status verified date

Mar, 2023

Completion date

Mar 15, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adults age 18-70 years (inclusive)
Existing diagnosis of IBS
Willing to take the 2'-FL-containing dietary supplement (or a control supplement) three times per day for 6 weeks
Willing to attend 4 in-person study visits
Willing to collect 3 stool samples at home
Willing to periodically monitor stool form/consistency (and log the information on a diary)
Willing to complete IBS symptom focused questionnaires
Willing to refrain from making changes in dietary supplements and medications for the duration of the study
Willing to maintain current dietary pattern for the duration of the study
Willing to maintain current exercise pattern for the duration of the study
Able to speak, read, and understand the English language
Able to provide written informed consent

Exclusion Criteria:

Do not have an active primary care provider or specialist managing their IBS
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)
Intake of prebiotic or fiber supplement(s) (current intake or intake within 2 weeks prior to screening and/or enrollment)
Intake of probiotic supplement(s) (current intake or intake within 2 weeks prior to screening and/or enrollment)
Use of antibiotic, antiparasitic, or antifungal medications orally or intravenously (current use or use within 2 weeks prior to screening and/or enrollment)
Initiation of or changes to an exercise regimen within 2 weeks prior to screening and/or enrollment
Initiation of or changes to a food plan within 2 weeks prior to screening and/or enrollment
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)
Current or previous history of chronic gastrointestinal illness other than IBS (e.g. inflammatory bowel disease, celiac disease, diverticulitis, cirrhosis, hepatitis, etc.)
History of gastrointestinal surgery other than appendectomy (e.g. weight loss surgery, cholecystectomy, splenectomy, etc.)
Major medical or surgical event requiring hospitalization (for any reason other than a minor scheduled medical procedure) within 3 months prior to screening
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)
Currently participating in another interventional research study or participated in another interventional study within 2 weeks prior to screening
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)
Women who are lactating, pregnant or planning pregnancy within the next 3 months

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Investigational supplement

Participants in this arm will take a supplement containing 2'-fucosyllactose (2'-FL)

placebo comparator: Placebo supplement

Participants in this arm will take a placebo supplement

Interventions

a supplement containing 2'-fucosyllactose (2'-FL)

Participants will be asked to take a commercially available dietary supplement containing 833 mg of 2'-FL, 220 mg of a blend of organic beet root and okra fruit, 100 mg of Collinsonia root, 37.5 mg organic rice hull concentrate, and 14 mg calcium stearate.

Placebo Supplement

Participants will be asked to take a placebo supplement containing 510.9 mg organic sucanat, 385.4 mg calcium phosphate, 304.7 mg cellulose, 143.4 mg date powder, 39.4 mg rice bran powder, 9.0 mg gum arabic, and 7.2 mg calcium stearate.

Primary outcome measure

F. Prausnitzii abundance [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Anders Gundersen, MS

503-552-1752 agundersen@nunm.edu

Locations

National University of Natural Medicine

Recruiting

Portland, Oregon, United States, 97201

Contacts

Anders Gundersen, MS

agundersen@nunm.edu

More Information

Sponsor

National University of Natural Medicine

Last update posted

Mar 24, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National University of Natural Medicine on 2023-03-24.