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Prebiotic

2'-Fucosyllactose Supplement for Irritable Bowel Syndrome

N/A

Recruiting

Led By Ryan Bradley, ND, MPH

Research Sponsored by National University of Natural Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults age 18-70 years (inclusive)

Willing to refrain from making changes in dietary supplements and medications for the duration of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial will test whether a dietary supplement containing 2'-FL impacts the composition of gut bacteria in adults with IBS. The primary measure is the abundance of Faecalibacterium prausnitzii, a commensal intestinal bacteria.

Who is the study for?

Adults aged 18-70 with IBS, able to consent and attend 4 visits, who speak English. They must not change their diet, exercise, or medications during the study and be willing to take a supplement thrice daily for 6 weeks. Excluded are those with recent cancer (except certain skin cancers), no active IBS management by a healthcare provider, recent medication changes or use of antibiotics/antifungals, major dietary program participants, significant GI surgery history other than appendectomy.Check my eligibility

What is being tested?

The trial tests if a dietary supplement containing 2'-fucosyllactose affects gut bacteria in adults with IBS. Participants will either receive this supplement or a placebo while researchers monitor changes in specific beneficial gut bacteria and overall microbial diversity through stool sample analysis.See study design

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions to supplements such as digestive discomfort or allergic reactions to any ingredient listed like Collinsonia root or beet root.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I agree not to change my medications or supplements during the study.

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I have been diagnosed with IBS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

F. Prausnitzii abundance

Secondary outcome measures

Alpha diversity of the microbiota

Beta diversity of the microbiota

Bifidobacterium spp. relative abundance

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Investigational supplementExperimental Treatment1 Intervention

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

Group II: Placebo supplementPlacebo Group1 Intervention

Participants in this arm will take a placebo supplement

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National University of Natural MedicineLead Sponsor

29 Previous Clinical Trials

1,277 Total Patients Enrolled

1 Trials studying Irritable Bowel Syndrome

18 Patients Enrolled for Irritable Bowel Syndrome

Ryan Bradley, ND, MPHPrincipal InvestigatorNational University of Natural Medicine

7 Previous Clinical Trials

189 Total Patients Enrolled

Media Library

a supplement containing 2'-fucosyllactose (2'-FL) (Prebiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05266287 — N/A

Irritable Bowel Syndrome Research Study Groups: Placebo supplement, Investigational supplement

Irritable Bowel Syndrome Clinical Trial 2023: a supplement containing 2'-fucosyllactose (2'-FL) Highlights & Side Effects. Trial Name: NCT05266287 — N/A

a supplement containing 2'-fucosyllactose (2'-FL) (Prebiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05266287 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enrolled in the research project?

"Affirmative. Clinicaltrials.gov reports that this medical experiment, which was initially listed on April 1st 2022, is presently seeking volunteers. This trial demands 50 participants to be enrolled at a single study site."

Answered by AI

What sorts of individuals are best suited to participating in this trial?

"This clinical trial is open to 50 individuals, aged 18-70, who have been diagnosed with IBS. Furthermore, interested patients must be willing to: take a dietary supplement 3 times daily for 6 weeks; attend 4 in-person study visits; collect and log stool samples from home; regularly record changes related to their bowel movements on a diary; answer symptom focused questionnaires; abstain from altering medications or supplements during the course of the experiment; maintain consistent exercise habits throughout the duration of this research project as well as refrain from making any dramatic adjustments to their diet regimen."

Answered by AI

Does this experiment include elderly individuals older than 75 years?

"This medical trial is accepting patients who are within the age range of 18 and 70 years old."

Answered by AI

Is this study currently open to enrollment?

"Verified. According to clinicaltrials.gov, this medical study is currently enrolling patients who were first posted on April 1st 2022 and has been recently updated on May 27th. The trial requires 50 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Changes in Microbiota and Quality of Life in IBS

Ryan Bradley 2022. "Changes in Microbiota and Quality of Life in IBS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05266287.