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

April 30, 2026 updated by: Université Catholique de Louvain
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Brabant Wallon
      • Louvain-la-Neuve, Brabant Wallon, Belgium, 1348
        • Recruiting
        • Center of Investigation in Clinical Nutrition (CICN)
        • Contact:
        • Principal Investigator:
          • Sylvie Copine, Dr
        • Contact:
        • Principal Investigator:
          • Simar Laurent, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the intensity and frequency of intestinal symptoms
Time Frame: Throughout the entire study, approximately during 10 months
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
Time Frame: Throughout the entire study, approximately during 10 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the intestinal-related quality of life
Time Frame: Throughout the entire study, approximately during 10 months
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
Time Frame: Throughout the entire study, approximately during 10 months
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
Time Frame: Throughout the entire study, approximately during 10 months
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
Time Frame: Throughout the entire study, approximately during 10 months
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
Time Frame: Throughout the entire study, approximately during 10 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 24, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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