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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Pain/ Discomfort; Intestinal Discomfort
• Intervention / Treatment: Dietary supplement: Berberine; Dietary supplement: Bifidobacterium longum; Dietary supplement: Bifidobacterium longum and Berberine; Dietary supplement: Placebo

Detailed Description

This study is designed as a randomized double-blind placebo-controlled interventional study. One hundred and forty individuals aged between 18 and 75 years and experiencing a measurable level of intestinal discomfort will be randomly allocated to one of the four groups (35 subjects per group): control, prebiotic only, postbiotic only, or combination of both. Subjects will receive their assigned supplementation for 8 weeks. Intestinal discomfort will be measured through tests and questionnaires at baseline, mid-intervention (week 4), at the end of intervention (week 8), and after a follow-up period of 4 weeks (week 12).

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie Dormal, PhD; Phone Number: +32(0)10 47 93 05; Email: valerie.dormal@uclouvain.be
• Study Contact Backup: Name: Louise Deldicque, Pr; Email: louise.deldicque@uclouvain.be

Study Locations

• Belgium
  • Brabant Wallon
    • Louvain-la-Neuve, Brabant Wallon, Belgium, 1348
      • Recruiting
      • Center of Investigation in Clinical Nutrition (CICN)
      • Contact: Valérie Dormal, PhD; Phone Number: +32(0)10 47 93 05; Email: valerie.dormal@uclouvain.be
      • Principal Investigator: Sylvie Copine, Dr
      • Contact: Louise Deldicque, Pr; Email: louise.deldicque@uclouvain.be
      • Principal Investigator: Simar Laurent, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, ...).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dietary supplement - Placebo	Dietary supplement: Placebo; The study foresees the intake of 3 capsules per day during 8 weeks
Experimental: Berberine; Dietary supplement - Berberine	Dietary supplement: Berberine; The study foresees the intake of 3 capsules per day during 8 weeks; Other Names: BBR
Experimental: Bifidobacterium longum; Dietary supplement - Bifidobacterium longum	Dietary supplement: Bifidobacterium longum; The study foresees the intake of 3 capsules per day during 8 weeks; Other Names: B.Longum
Experimental: Bifidobacterium longum and Berberine; Dietary supplement - Bifidobacterium longum and Berberine	Dietary supplement: Bifidobacterium longum and Berberine; The study foresees the intake of 3 capsules per day during 8 weeks; Other Names: B.longum and BBR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the intestinal-related quality of life	Comparison between groups in the change from baseline of intestinal-related quality of life, measured by the Irritable Bowel Syndrome - Quality of life (IBS-QoL) questionnaire	Throughout the entire study, approximately during 10 months
Change from baseline in the intestinal permeability	Comparison between groups in the change from baseline of the intestinal permeability, measured by plasma level of LBP	Throughout the entire study, approximately during 10 months
Change from baseline in the microbiota composition	Comparison between groups of the change from baseline in the microbiota composition, assessed using DNA extraction followed by high-throughput sequencing of the 16S rRNA gene	Throughout the entire study, approximately during 10 months
Product satisfaction	Comparison between groups in product satisfaction (5-point Likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied)	Throughout the entire study, approximately during 10 months
Self-perceived gut symptoms enhancement	Comparison between groups in self-perceived gut symptoms enhancement (7-point Likert scale ranging from 1 = Significant deterioration to 7 = Significant improvement with five items: intestinal comfort, abdominal pain, bloating, bowel movement frequency, and stool type)	Throughout the entire study, approximately during 10 months

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Sylvie Copine, Dr, Université Catholique de Louvain; Study Director: Louise Deldicque, Pr, Université Catholique de Louvain; Principal Investigator: Laurent Simar, Dr, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): October 24, 2026
• Study Completion (Estimated): December 24, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Berberine; Intestinal discomfort; B.Longum
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Benzylisoquinolines; Berberine Alkaloids; Berberine
• Other Study ID Numbers: SYNFOOD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No