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

NCT07420231 | Recruiting

• 1 other identifier: SYNFOOD
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Intestinal Discomfort; Abdominal Pain/ Discomfort

Keywords

Intestinal discomfort; B.Longum; Berberine

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the intensity and frequency of intestinal symptoms

  Comparison between groups in the change from baseline of the intensity and frequency of intestinal symptoms measured by Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS)

  Throughout the entire study, approximately during 10 months

• Change from baseline in the intensity and frequency of intestinal symptoms

  Comparison between groups in the change from baseline of the intensity and frequency of intestinal symptoms measured by Gut symptoms and transit evaluation (GSTE)

  Throughout the entire study, approximately during 10 months

Secondary Outcomes (5)

• Change from baseline in the intestinal-related quality of life

  Throughout the entire study, approximately during 10 months

• Change from baseline in the intestinal permeability

  Throughout the entire study, approximately during 10 months

• Change from baseline in the microbiota composition

  Throughout the entire study, approximately during 10 months

• Product satisfaction

  Throughout the entire study, approximately during 10 months

• Self-perceived gut symptoms enhancement

  Throughout the entire study, approximately during 10 months

Study Arms (4)

Berberine

EXPERIMENTAL

Dietary supplement - Berberine

Dietary Supplement: Berberine

Bifidobacterium longum

EXPERIMENTAL

Dietary supplement - Bifidobacterium longum

Dietary Supplement: Bifidobacterium longum

Bifidobacterium longum and Berberine

EXPERIMENTAL

Dietary supplement - Bifidobacterium longum and Berberine

Dietary Supplement: Bifidobacterium longum and Berberine

Placebo

PLACEBO COMPARATOR

Dietary supplement - Placebo

Dietary Supplement: Placebo

Interventions

Berberine DIETARY_SUPPLEMENT

The study foresees the intake of 3 capsules per day during 8 weeks

Also known as: BBR

Berberine

Bifidobacterium longum DIETARY_SUPPLEMENT

The study foresees the intake of 3 capsules per day during 8 weeks

Also known as: B.Longum

Bifidobacterium longum

Bifidobacterium longum and Berberine DIETARY_SUPPLEMENT

The study foresees the intake of 3 capsules per day during 8 weeks

Also known as: B.longum and BBR

Bifidobacterium longum and Berberine

Placebo DIETARY_SUPPLEMENT

The study foresees the intake of 3 capsules per day during 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Experience recurrent abdominal pain present for at least three months and occurring on a regular basis;
• The abdominal discomfort must have a low to moderate impact on quality of life;
• 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;

You may not qualify if:

• 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, ...).

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Center of Investigation in Clinical Nutrition (CICN)

Louvain-la-Neuve, Brabant Wallon, 1348, Belgium

RECRUITING

MeSH Terms

Interventions

Berberine

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Louise Deldicque, Pr

  Université Catholique de Louvain

  STUDY DIRECTOR

• Sylvie Copine, Dr

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

• Laurent Simar, Dr

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Dormal, PhD

CONTACT

+32(0)10 47 93 05; valerie.dormal@uclouvain.be

Louise Deldicque, Pr

CONTACT

louise.deldicque@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): October 24, 2026
• Study Completion (Estimated): December 24, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)