NCT05266287

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

February 23, 2022

Last Update Submit

March 22, 2023

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • F. Prausnitzii abundance

    F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and quantified

    6 weeks

Secondary Outcomes (7)

  • F. Prausnitzii relative abundance

    6 weeks

  • Bifidobacterium spp. relative abundance

    6 weeks

  • Alpha diversity of the microbiota

    6 weeks

  • Beta diversity of the microbiota

    6 weeks

  • IBS-Severity Scoring System

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Investigational supplement

EXPERIMENTAL

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

Dietary Supplement: a supplement containing 2'-fucosyllactose (2'-FL)

Placebo supplement

PLACEBO COMPARATOR

Participants in this arm will take a placebo supplement

Dietary Supplement: Placebo Supplement

Interventions

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

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.

Investigational supplement
Placebo SupplementDIETARY_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.

Placebo supplement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Natural Medicine

Portland, Oregon, 97201, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ryan Bradley, ND, MPH

    National University of Natural Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Gundersen, MS

CONTACT

503-552-1752agundersen@nunm.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 4, 2022

Study Start

April 1, 2022

Primary Completion

December 31, 2023

Study Completion

March 15, 2024

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

US(1)