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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine | Experimental | Dietary supplement - Berberine |
|
| Bifidobacterium longum | Experimental | Dietary supplement - Bifidobacterium longum |
|
| Bifidobacterium longum and Berberine | Experimental | Dietary supplement - Bifidobacterium longum and Berberine |
|
| Placebo | Placebo Comparator | Dietary supplement - Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine | Dietary Supplement | The study foresees the intake of 3 capsules per day during 8 weeks |
|
| 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 |
| 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 |
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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:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerie Dormal, PhD | Contact | +32(0)10 47 93 05 | valerie.dormal@uclouvain.be | |
| Louise Deldicque, Pr | Contact | louise.deldicque@uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Louise Deldicque, Pr | Université Catholique de Louvain | Study Director |
| Sylvie Copine, Dr | Université Catholique de Louvain | Principal Investigator |
| Laurent Simar, Dr |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Investigation in Clinical Nutrition (CICN) | Recruiting | Louvain-la-Neuve | Brabant Wallon | 1348 | Belgium |
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Parallel Assignment Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
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| Bifidobacterium longum | Dietary Supplement | The study foresees the intake of 3 capsules per day during 8 weeks |
|
|
| Bifidobacterium longum and Berberine | Dietary Supplement | The study foresees the intake of 3 capsules per day during 8 weeks |
|
|
| Placebo | Dietary Supplement | The study foresees the intake of 3 capsules per day during 8 weeks |
|
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 |
| Université Catholique de Louvain |
| Principal Investigator |
| ID | Term |
|---|---|
| D001599 | Berberine |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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