Intestinal Discomfort, Abdominal Pain/ Discomfort
Conditions
Keywords
Intestinal discomfort, B.Longum, Berberine
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.
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).
Interventions
DIETARY_SUPPLEMENTBerberine
The study foresees the intake of 3 capsules per day during 8 weeks
DIETARY_SUPPLEMENTBifidobacterium longum
The study foresees the intake of 3 capsules per day during 8 weeks
DIETARY_SUPPLEMENTBifidobacterium longum and Berberine
The study foresees the intake of 3 capsules per day during 8 weeks
DIETARY_SUPPLEMENTPlacebo
The study foresees the intake of 3 capsules per day during 8 weeks
Sponsors
Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment Comparative, randomized, placebo-controlled, double-blind, monocentric interventional study in parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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, ...).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the intensity and frequency of intestinal symptoms | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the intestinal-related quality of life | 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 |
| Change from baseline in the intestinal permeability | 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 |
| Change from baseline in the microbiota composition | 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 |
| Product satisfaction | 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) |
| Self-perceived gut symptoms enhancement | 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) |
Countries
Belgium
Contacts
CONTACTValerie Dormal, PhD
CONTACTLouise Deldicque, Pr
STUDY_DIRECTORLouise Deldicque, Pr
Université Catholique de Louvain
PRINCIPAL_INVESTIGATORSylvie Copine, Dr
Université Catholique de Louvain
PRINCIPAL_INVESTIGATORLaurent Simar, Dr
Université Catholique de Louvain
Outcome results
None listed