Combining berberine and inactivated Bifidobacterium longum to ease intestinal discomfort

Evaluation of the Synergistic Effect of Combining a Prebiotic and a Postbiotic on Intestinal Discomfort

This trial will test if daily berberine (a prebiotic) and an inactivated Bifidobacterium longum (a postbiotic), given alone or together, can reduce intestinal discomfort in adults with recurrent abdominal pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Université Catholique de Louvain (Academic / other)
• Locations: 1 site (Louvain-la-Neuve, Brabant Wallon)
• Trial ID: NCT07420231 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled trial enrolling 140 adults aged 18–75 with measurable intestinal discomfort. Participants are randomly assigned to one of four groups (placebo, berberine only, inactivated B. longum only, or the combination) and take the assigned supplement for 8 weeks. Outcomes are measured by questionnaires and tests at baseline, week 4, week 8, and at a 4-week follow-up (week 12). The intervention combines a prebiotic (berberine) and a postbiotic (inactivated B. longum) to test for synergistic effects on gastrointestinal symptoms.

Who should consider this trial

Good fit: Adults 18–75 with recurrent abdominal pain for at least three months, a low-to-moderate impact on quality of life, at least two related gastrointestinal symptoms, a BMI of 18–30 kg/m², and willingness to follow study procedures are ideal candidates.

Not a fit: People without measurable intestinal discomfort, with severe gastrointestinal disease or high-impact symptoms, outside the 18–75 age range or BMI 18–30, or unable to attend study visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could reduce abdominal pain and other gut symptoms and improve daily comfort and quality of life for people with intestinal discomfort.

How similar studies have performed: Prior research on berberine, Bifidobacterium strains, and other synbiotics has shown mixed but sometimes promising improvements in IBS-type symptoms, making this specific combination somewhat novel but grounded in existing evidence.

Eligibility criteria

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, ...).

Where this trial is running

Louvain-la-Neuve, Brabant Wallon

• Center of Investigation in Clinical Nutrition (CICN) — Louvain-la-Neuve, Brabant Wallon, Belgium (Recruiting)

Study contacts

• Principal investigator: Sylvie Copine, Dr — Université Catholique de Louvain
• Study coordinator: Valerie Dormal, PhD

Conditions Intestinal Discomfort; Abdominal Pain/ Discomfort; Intestinal discomfort; B.Longum; Berberine