Could a daily capsule soothe your tummy troubles?
NCT ID NCT07420231
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether taking a combination of a prebiotic (berberine) and a postbiotic (inactivated Bifidobacterium longum) for 8 weeks can reduce belly pain and discomfort in adults. 140 people with ongoing gut issues will be randomly assigned to get the combo, one of the ingredients alone, or a placebo. The goal is to see if this synbiotic blend improves symptoms and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Berberine (prebiotic) and inactivated Bifidobacterium longum (postbiotic) taken as capsules
- What this could lead to
- If it works, this could offer a simple, natural way to reduce belly pain and bloating for people with ongoing gut discomfort.
- What could go wrong
- This is an early-stage trial with no phase, so results are uncertain. The effect may be small or no better than placebo, and supplements are not regulated like drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Woman or man, aged of 18 to 75 years (inclusive); * Subject with a measurable level of intestinal discomfort, assessed using a questionnaire inspired by the ROME IV criteria. Eligible participants must meet all of the following conditions: 1. Experience recurrent abdominal pain present for at least three months and occurring on a regular basis; 2. The abdominal discomfort must have a low to moderate impact on quality of life; 3. In addition, participants must report at least two of the following gastrointestinal symptoms: * Diarrhea * Constipation * Bloating * Excessive flatulence * Nausea * Burping * Sensation of incomplete evacuation * Urgent need to defecate; * Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive); * Provision of signed and dated informed consent form; * Stated willingness to comply with all study procedures and availability for the duration of the study; * Stated willingness to maintain their usual life habits (diet, physical activity, alcohol consumption…); * Speaking French. Exclusion Criteria: * Subject with severe or chronic medical conditions which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study outcomes or compromise participant safety; * Subject with a diagnosed gastrointestinal disorder (e.g., Crohn's disease, inflammatory bowel disease, or other chronic digestive conditions); * Subject with type 1 or type 2 diabetes; * Subject who has taken, within the 28 days prior to the screening visit, or are currently taking, drugs or food supplements intended to improve intestinal comfort, or any other substances that, in the opinion of the Principal Investigator, could interfere with intestinal comfort assessment or transit frequency (prebiotics, laxative, anti-diarrheal, probiotics, postbiotics, synbiotics). These products will also be avoided for the duration of the study; * Subject who has taken antibiotics within the 3 months prior to the screening visit. These products will also be avoided for the duration of the study; * Subjects undergoing medical treatment which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study criteria or with participant safety: antidepressants, immunosuppressants, antipsychotics, antispasmodics, anxiolytics, neuroleptics. These products will also be avoided for the duration of the study; * Subject who had undergone bariatric surgery; * Subject consuming more than 5 cups of coffee per day; * Subject currently using drugs and/or with a history of drug addiction within the past 2 years; * Subject with regular alcohol consumption exceeding 3 standard drinks per day (10 g of pure alcohol each), equivalent to 3 glasses of wine (12 cl), 3 glasses of beer (5°, 25cl), or 3 glasses of spirits (18°, 7 cl); * Subject with known hypersensitivity to any component of the study product; * Subject currently participating in another interventional trial; * Woman of childbearing age who is pregnant or breastfeeding or who wishes to become pregnant within the next 12 weeks or who is not using an adequate method of contraception (e.g. oral contraception, IUD, abstinence, ...).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Center of Investigation in Clinical Nutrition (CICN)
RECRUITINGLouvain-la-Neuve, Brabant Wallon, 1348, Belgium
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