Intestinal DiscomfortSynfoodNCT07420231

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

A study testing Berberine, Bifidobacterium longum and Bifidobacterium longum and Berberine in people with Intestinal Discomfort and Abdominal Pain/ Discomfort, run by Université Catholique de Louvain at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Intestinal Discomfort, Abdominal Pain/ Discomfort
What is being tested?: Berberine, Bifidobacterium longum and Bifidobacterium longum and Berberine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 1 siteBelgium
Study dates: 16 Mar 2026to 24 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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;

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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, ...).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Valerie Dormal, PhD contact

+32(0)10 47 93 05

valerie.dormal@uclouvain.be

Louise Deldicque, Pr contact

louise.deldicque@uclouvain.be

Belgium1 site, 1 recruiting

Center of Investigation in Clinical Nutrition (CICN)
Louvain-la-Neuve, Brabant Wallon, 1348
Valérie Dormal, PhD, +32(0)10 47 93 05, valerie.dormal@uclouvain.be
Louise Deldicque, Pr, louise.deldicque@uclouvain.be
Recruiting

Other trials in Belgium

About this study

Read the 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).

Conditions: Intestinal Discomfort, Abdominal Pain/ Discomfort
Being tested: Berberine, Bifidobacterium longum, Bifidobacterium longum and Berberine, Placebo
Keywords: Intestinal discomfort, B.Longum, Berberine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BerberineDietary supplement
Also called BBR
The study foresees the intake of 3 capsules per day during 8 weeks
Bifidobacterium longumDietary supplement
Also called B.Longum
The study foresees the intake of 3 capsules per day during 8 weeks
Bifidobacterium longum and BerberineDietary supplement
Also called B.longum and BBR
The study foresees the intake of 3 capsules per day during 8 weeks
PlaceboDietary supplement
The study foresees the intake of 3 capsules per day during 8 weeks

Study groups in NCT07420231
Study group	Role	What they receive
Berberine	Experimental	Dietary supplement - Berberine Receives: Dietary Supplement: Berberine
Bifidobacterium longum	Experimental	Dietary supplement - Bifidobacterium longum Receives: Dietary Supplement: Bifidobacterium longum
Bifidobacterium longum and Berberine	Experimental	Dietary supplement - Bifidobacterium longum and Berberine Receives: Dietary Supplement: Bifidobacterium longum and Berberine
Placebo	Placebo comparator	Dietary supplement - Placebo Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: Throughout the entire study, approximately during 10 months

Secondary outcomes (5)

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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Throughout the entire study, approximately during 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 202624 Dec 2026

First posted19 Feb 2026
Study start16 Mar 2026
Primary completion24 Oct 2026 (estimated)
Study completion24 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intestinal DiscomfortStudies of the same condition, open and under way.
More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07420231
Sponsor's protocol ID: SYNFOOD
Acronym: Synfood
Status last verified: Apr 2026
First submitted: 12 Feb 2026
Last updated: 6 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Valerie Dormal, PhD

+32(0)10 47 93 05

valerie.dormal@uclouvain.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Intestinal Discomfort trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Synergistic Effect of Combining a Prebiotic and a Postbiotic on Intestinal Discomfort
ClinicalTrials.gov ID: NCT07420231
Acronym / sponsor ID: Synfood / SYNFOOD
Conditions: Intestinal Discomfort, Abdominal Pain/ Discomfort
Keywords: Intestinal discomfort, B.Longum, Berberine
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 140 participants (estimated)
Lead sponsor: Université Catholique de LouvainUniversity, hospital or other
Study start: 16 Mar 2026 (actual)
Primary completion: 24 Oct 2026 (estimated)
Study completion: 24 Dec 2026 (estimated)
First posted: 19 Feb 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Parallel Assignment Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups

Arm	Type	Receives
Berberine	Experimental	Dietary Supplement: BerberineDietary supplement - Berberine
Bifidobacterium longum	Experimental	Dietary Supplement: Bifidobacterium longumDietary supplement - Bifidobacterium longum
Bifidobacterium longum and Berberine	Experimental	Dietary Supplement: Bifidobacterium longum and BerberineDietary supplement - Bifidobacterium longum and Berberine
Placebo	Placebo comparator	Dietary Supplement: PlaceboDietary supplement - Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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:
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;

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BerberineAlso: BBRThe study foresees the intake of 3 capsules per day during 8 weeks	Dietary supplement	Berberine
Bifidobacterium longumAlso: B.LongumThe study foresees the intake of 3 capsules per day during 8 weeks	Dietary supplement	Bifidobacterium longum
Bifidobacterium longum and BerberineAlso: B.longum and BBRThe study foresees the intake of 3 capsules per day during 8 weeks	Dietary supplement	Bifidobacterium longum and Berberine
PlaceboThe study foresees the intake of 3 capsules per day during 8 weeks	Dietary supplement	Placebo

Primary outcome

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)
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)

5 secondary outcomes

Change from baseline in the intestinal-related quality of life
Time frame: 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
Change from baseline in the microbiota composition
Time frame: Throughout the entire study, approximately during 10 months
Product satisfaction
Time frame: Throughout the entire study, approximately during 10 months
Self-perceived gut symptoms enhancement
Time frame: Throughout the entire study, approximately during 10 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Valerie Dormal, PhD contact

+32(0)10 47 93 05

valerie.dormal@uclouvain.be

Louise Deldicque, Pr contact

louise.deldicque@uclouvain.be

Louise Deldicque, Pr study director

Université Catholique de Louvain

Sylvie Copine, Dr principal investigator

Université Catholique de Louvain

Laurent Simar, Dr principal investigator

Université Catholique de Louvain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Valerie Dormal, PhD (+32(0)10 47 93 05, valerie.dormal@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the intensity and frequency of intestinal symptoms (time frame: Throughout the entire study, approximately during 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07420231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.