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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 belowSelect...
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
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 moreTrial 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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 70 years old.I am willing to take a dietary supplement three times daily for 6 weeks.I am willing to fill out questionnaires about my IBS symptoms.I agree not to change my medications or supplements during the study.I have had surgery on my digestive system, not including appendix removal.I haven't started or changed any medications or supplements in the last 2 weeks.I have taken probiotic supplements recently or am currently taking them.I have a history of chronic gastrointestinal illness other than IBS.I have been diagnosed with IBS.I haven't taken any antibiotics, antiparasitics, or antifungals recently.I am not pregnant, breastfeeding, or planning to become pregnant soon.I am willing to collect 3 stool samples at home.I was diagnosed or treated for cancer, excluding some skin cancers and early cervical cancer, in the last 5 years.I haven't been hospitalized for a major event in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo supplement
- Group 2: Investigational supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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