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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
The study foresees the intake of 3 capsules per day during 8 weeks
The study foresees the intake of 3 capsules per day during 8 weeks
The study foresees the intake of 3 capsules per day during 8 weeks
Center of Investigation in Clinical Nutrition (CICN)
Louvain-la-Neuve, Brabant Wallon, Belgium
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)
Time frame: 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)
Time frame: Throughout the entire study, approximately during 10 months
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
Time frame: 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
Time frame: 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
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The study foresees the intake of 3 capsules per day during 8 weeks
Time frame: 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)
Time frame: Throughout the entire study, approximately during 10 months