ClinicalTrials.gg
Status unknownNCT05266287Updated Mar 24, 2023

Changes in Microbiota and Quality of Life in IBS

An interventional study of a supplement containing 2'-fucosyllactose (2'-FL) and Placebo Supplement in IBS - Irritable Bowel Syndrome, sponsored by National University of Natural Medicine. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by National University of Natural Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • IBS - Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.

This study's planned enrollment of 50 is below the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

National University of Natural Medicine is the lead sponsor of 39 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Investigational supplement

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

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

  • Placebo comparator
    Placebo supplement

    Participants in this arm will take a placebo supplement

    Dietary Supplement: Placebo Supplement

Interventions

  • Dietary supplementa 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.

  • Dietary supplementPlacebo 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.

06

What researchers measure

Primary outcomes

  1. F. Prausnitzii abundance

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

    Time frame: 6 weeks

Secondary outcomes

  1. F. Prausnitzii relative abundance

    F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and the proportion to other organisms calculated

    Time frame: 6 weeks

  2. Bifidobacterium spp. relative abundance

    Bifidobacterium spp. relative abundance in stool will be measured via 16s RNA sequencing and the proportion to other organisms calculated

    Time frame: 6 weeks

  3. Alpha diversity of the microbiota

    Alpha diversity is a measure of overall diversity of organisms within in a stool sample

    Time frame: 6 weeks

  4. Beta diversity of the microbiota

    Beta diversity is a measure of overall diversity of organisms between stool samples in the cohort of participants

    Time frame: 6 weeks

  5. IBS-Severity Scoring System

    Validated instrument that quantified patient-reported IBS severity

    Time frame: 6 weeks

  6. IBS-Adequate Relief from Symptoms

    Validated instrument that measures patient-reported relief from IBS symptoms

    Time frame: 6 weeks

  7. Bristol Stool Form Scale

    7-point scale used qualitatively assessing form of stool

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • National University of Natural Medicine
    Portland, Oregon 97201, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2022 (actual). Primary completion is estimated for Dec 2023, 20 months after the start.

Of 297 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 20 months is close to that.

Counting every sponsor, half of 345 studies reached it within 19 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2022
First posted
Mar 4, 2022
StartActual
Apr 1, 2022
Primary completionEst.
Dec 31, 2023
CompletionEst.
Mar 15, 2024
Last update
Mar 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05266287
Lead sponsor
National University of Natural Medicine
Responsible party
Ryan Bradley (Director of Research, National University of Natural Medicine) — Principal investigator
First posted
Mar 4, 2022
Start date
Apr 1, 2022
Primary completion
Dec 31, 2023 (estimated)
Completion
Mar 15, 2024 (estimated)
Last update
Mar 24, 2023

Study contacts

Anders Gundersen, MS
Contact
agundersen@nunm.edu
503-552-1752
Ryan Bradley, ND, MPH
principal investigator · National University of Natural Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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