Changes in Microbiota and Quality of Life in IBS

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.

Study Overview

• Status: Recruiting
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: a supplement containing 2'-fucosyllactose (2'-FL); Dietary supplement: Placebo Supplement

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • Recruiting
      • National University of Natural Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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 Comparator: Placebo supplement; Participants in this arm will take a placebo supplement	Dietary supplement: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
F. Prausnitzii abundance	F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and quantified	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
F. Prausnitzii relative abundance	F. Prausnitzii abundance will be measured in stool via 16s RNA sequencing and the proportion to other organisms calculated	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	6 weeks
Alpha diversity of the microbiota	Alpha diversity is a measure of overall diversity of organisms within in a stool sample	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	6 weeks
IBS-Severity Scoring System	Validated instrument that quantified patient-reported IBS severity	6 weeks
IBS-Adequate Relief from Symptoms	Validated instrument that measures patient-reported relief from IBS symptoms	6 weeks
Bristol Stool Form Scale	7-point scale used qualitatively assessing form of stool	6 weeks

Collaborators and Investigators

• Sponsor: National University of Natural Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 15, 2024

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: RB120721

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No