Actively Recruiting
Evaluation of the Synergistic Effect of Combining a Prebiotic and a Postbiotic on Intestinal Discomfort
Led by Université Catholique de Louvain · Updated on 2026-05-06
140
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to investigate the beneficial effects of the daily consumption of a synbiotic formulation-combining a prebiotic (Berberine, BBR) and a postbiotic (inactivated Bifidobacterium Longum, B.longum)-in adults experiencing intestinal discomfort.
CONDITIONS
Official Title
Evaluation of the Synergistic Effect of Combining a Prebiotic and a Postbiotic on Intestinal Discomfort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman or man, aged 18 to 75 years (inclusive)
- Measurable intestinal discomfort with recurrent abdominal pain for at least three months
- Abdominal discomfort with low to moderate impact on quality of life
- At least two gastrointestinal symptoms: diarrhea, constipation, bloating, excessive flatulence, nausea, burping, sensation of incomplete evacuation, or urgent need to defecate
- Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive)
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Willingness to maintain usual life habits (diet, physical activity, alcohol consumption)
- Ability to speak French
You will not qualify if you...
- Severe or chronic medical conditions interfering with study outcomes or safety
- Diagnosed gastrointestinal disorders (e.g., Crohn's disease, inflammatory bowel disease)
- Type 1 or type 2 diabetes
- Use of drugs or supplements affecting intestinal comfort within 28 days prior to screening or during study
- Antibiotic use within 3 months prior to screening or during study
- Medical treatments interfering with study or safety (antidepressants, immunosuppressants, antipsychotics, antispasmodics, anxiolytics, neuroleptics)
- History of bariatric surgery
- Consumption of more than 5 cups of coffee per day
- Current or recent drug addiction within past 2 years
- Regular alcohol consumption exceeding 3 standard drinks per day
- Known hypersensitivity to any study product component
- Participation in another interventional trial
- Pregnant or breastfeeding women or those not using adequate contraception within 12 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center of Investigation in Clinical Nutrition (CICN)
Louvain-la-Neuve, Brabant Wallon, Belgium, 1348
Actively Recruiting
Research Team
V
Valerie Dormal, PhD
CONTACT
L
Louise Deldicque, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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