The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged… (NCT07453823) | Clinical Trial Compass
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The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight
Ireland90 participantsStarted 2026-03-18
Plain-language summary
The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic.
The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.
Who can participate
Age range50 Years – 70 Years
SexALL
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Inclusion criteria
✓. Be able to give informed consent.
✓. Be between 50 to 70 years of age (inclusive).
✓. BMI ranging from 25.0 and 35.0 kg/m²
✓. Willing to maintain current level of physical activity and diet during the participation in the study.
✓. Experience ≤3 bowel movements per week within the month prior to screening
✓. Participants reported subclinical mild to moderate gastrointestinal complaints as defined by GSRS-IBS score 20-45 at screening.
✓. Willing to consume the study product daily for the duration of the study.
✓. Willing to eat the same meal the evening before visiting site (visit 2 to visit 5).
Exclusion criteria
✕. Has a history of drug and/or alcohol abuse.
✕. Has food allergies, or other issues with foods, that would preclude intake of the study products.
What they're measuring
1
Bifidobacterium abundance
Timeframe: From baseline to end of intervention at 8 weeks
✕. Smoking, chewable tobacco and/or vaping and/or use of other nicotine products.
✕. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
✕. diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome (IBS)
✕. GI surgery that might have an effect on gastrointestinal tract function except cholecystectomy and appendectomy in the past 5 years or any major bowel resection at any time.