Actively Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight
Led by Chr Hansen - part of Novonesis · Updated on 2026-04-15
90
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent
- Aged between 50 and 70 years inclusive
- Body mass index (BMI) between 25.0 and 35.0 kg/m²
- Willing to maintain current diet and physical activity during the study
- Experience 3 or fewer bowel movements per week in the month before screening
- Report mild to moderate gastrointestinal complaints with GSRS-IBS score between 20 and 45 at screening
- Willing to consume the study product daily for the study duration
- Willing to eat the same meal the evening before visits 2 to 5
- Have an average GSRS-IBS symptom score between 20 and 45 during the two-week run-in period
- Record 6 or fewer bowel movements in the daily diary during the two-week run-in period
You will not qualify if you...
- History of drug or alcohol abuse
- Food allergies or issues preventing intake of study products
- Use of smoking, chewing tobacco, vaping, or other nicotine products
- Significant acute or chronic health conditions preventing study participation or confounding results, including:
- Diagnosed gastrointestinal diseases (gastric/duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome
- Gastrointestinal surgery affecting gut function except cholecystectomy and appendectomy within past 5 years or any major bowel resection at any time
- History of cardiovascular disease
- Uncontrolled hypertension
- Use of medications interfering with study objectives or safety, including:
- Systemic antimicrobials within 4 weeks before visit 1
- OTC digestive symptom medications (PPIs, anti-spasmodics, laxatives, anti-diarrheal) within 2 weeks before visit 1
- Immunosuppressants or systemic steroids within 4 weeks before visit 1
- Regular oral NSAIDs within 1 week before visit 1 (topical NSAIDs allowed; low-dose aspirin allowed if stable 3 months prior)
- Use of prohibited supplements or foods within specified timeframes before visit 1, including herbal digestive supplements, high-dose vitamins/minerals, probiotics, iron supplements, and probiotic yogurts
- Planned major lifestyle changes during the study period
- Poor attendance or inability to comply with study requirements
- Participation in other clinical studies without sufficient washout period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Atlantia Clinical Trials Ltd
Cork, Blackpool, Ireland, T23 R50R
Actively Recruiting
Research Team
S
Sara Engel, PhD
CONTACT
E
Emma Harrington
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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