IBS - Irritable Bowel SyndromeNCT05266287
Changes in Microbiota and Quality of Life in IBS
A study testing a supplement containing 2'-fucosyllactose (2'-FL) in people with IBS - Irritable Bowel Syndrome, run by National University of Natural Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- a supplement containing 2'-fucosyllactose (2'-FL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National University of Natural Medicine
Portland, Oregon, 97201
Anders Gundersen, MS, agundersen@nunm.edu
About this study
Official title: Evaluating Changes in Microbiota Composition and Quality of Life in Irritable Bowel Syndrome: A Randomized, Controlled Trial
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
- Being tested
- a supplement containing 2'-fucosyllactose (2'-FL), Placebo Supplement
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational supplement | Experimental | Participants in this arm will take a supplement containing 2'-fucosyllactose (2'-FL) Receives: Dietary Supplement: a supplement containing 2'-fucosyllactose (2'-FL) |
| Placebo supplement | Placebo comparator | Participants in this arm will take a placebo supplement Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
F. Prausnitzii abundance
- Prausnitzii abundance will be measured in stool via 16s RNA sequencing and quantified
Measured: 6 weeks
Secondary outcomes (7)
F. Prausnitzii relative abundance
- Prausnitzii abundance will be measured in stool via 16s RNA sequencing and the proportion to other organisms calculated
Measured: 6 weeks
Bifidobacterium spp. relative abundance
Bifidobacterium spp. relative abundance in stool will be measured via 16s RNA sequencing and the proportion to other organisms calculated
Measured: 6 weeks
Alpha diversity of the microbiota
Alpha diversity is a measure of overall diversity of organisms within in a stool sample
Measured: 6 weeks
Beta diversity of the microbiota
Beta diversity is a measure of overall diversity of organisms between stool samples in the cohort of participants
Measured: 6 weeks
IBS-Severity Scoring System
Validated instrument that quantified patient-reported IBS severity
Measured: 6 weeks
IBS-Adequate Relief from Symptoms
Validated instrument that measures patient-reported relief from IBS symptoms
Measured: 6 weeks
Bristol Stool Form Scale
7-point scale used qualitatively assessing form of stool
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Bradley, National University of Natural Medicine
- Investigators
- Ryan Bradley, ND, MPH, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266287
- Sponsor's protocol ID
- RB120721
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Changes in Microbiota Composition and Quality of Life in Irritable Bowel Syndrome: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05266287
- Acronym / sponsor ID
- RB120721
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational supplement | Experimental | Dietary Supplement: a supplement containing 2'-fucosyllactose (2'-FL)Participants in this arm will take a supplement containing 2'-fucosyllactose (2'-FL) |
| Placebo supplement | Placebo comparator | Dietary Supplement: Placebo SupplementParticipants in this arm will take a placebo supplement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Investigational supplement |
| Placebo SupplementParticipants 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. | Dietary supplement | Placebo supplement |
Primary outcome
F. Prausnitzii abundance
Time frame: 6 weeks
F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and quantified
7 secondary outcomes
F. Prausnitzii relative abundance
Time frame: 6 weeks
Bifidobacterium spp. relative abundance
Time frame: 6 weeks
Alpha diversity of the microbiota
Time frame: 6 weeks
Beta diversity of the microbiota
Time frame: 6 weeks
IBS-Severity Scoring System
Time frame: 6 weeks
IBS-Adequate Relief from Symptoms
Time frame: 6 weeks
Bristol Stool Form Scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Bradley, ND, MPH principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a supplement containing 2'-fucosyllactose (2'-FL) in people with IBS - Irritable Bowel Syndrome, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Gundersen, MS (503-552-1752, agundersen@nunm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F. Prausnitzii abundance (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.