An interventional study of PROBAFLOR and Placebo in Gut and Microbiota Balance, sponsored by Synbiotec Srl. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Synbiotec Srl · Not applicable, Interventional, and Prevention
It is now known that intestinal health has a strong influence on the entire body. Recent research advances have demonstrated the involvement of the intestinal microbiota in the well-being of the intestine. Preventive medicine is increasingly perceived as important in medical and economic terms, particularly in the field of gastroenterology. An innovative approach to support gut health is based on the use of modulators of the intestinal microbiome or gastrointestinal barrier, such as probiotics or prebiotics. The rationale for this study is therefore based on the hypothesis that the combination of 11 probiotic strains, conveyed through the PROBAFLOR food supplement, can play a positive role in maintaining normal intestinal function, bringing benefits to the subject who takes this supplement.
This is a randomized, double-blind, placebo-controlled intervention study with a duration of 3 months of intervention + 1 month of follow-up, on biological samples. Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 3 months. Three check-in visits will occur, one at the screening, the second one afetr the 3-months intervention and the final one after 1 month of followup. Participants will be expected to complete a daily study diary documenting their investigational product use/adverse events and a daily bowel habits diary documenting each bowel movement. Stool samples, and questionnaires will be completed for study outcome analysis.
Synbiotec Srl is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary supplement: PROBAFLOR 20 Billion CFU/dose, serving size = 1 capsule/day
Dietary Supplement: PROBAFLOR
Placebo Placebo product, serving size = 1 capsule/day
Other: Placebo
PROBAFLOR is a food supplement made up of 11 bacterial strains and inulin. The bacterial strains present are: Bifidobacterium lactis BLC1, Lactococcus lactis LL82, Lactobacillus plantarum 14D, Lactobacillus acidophilus LA1, Streptococcus thermophilus Z57, Bifidobacterium longum SP54, Lactobacillus rhamnosus SP1, Lactobacillus bulgaricus LB2, Bifidobacterium bifidum SP9,Lactobacillus salivarius SP2, Lactobacillus casei BGP93.
Placebo
maintenance and/or improvement of intestinal health and health-related quality of life (through the GIQLI questionnaire)
Time frame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
Intestinal microbiota composition
Metagenomic analysis on faecal samples
Time frame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
SCFA determination
Gas chromatographic analysis of fecal water
Time frame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
Changes in quality of life.
Assessed by PGWBI (The Psychological General Well-Being Index)
Time frame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
Changes in intestinal functionality
Assessed in accordance with the Bristol Stool Form Scale
Time frame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
Changes on gastrointestinal symptoms
Assessed by the GSRS (Gastrointestinal Symptom Rating Scale)
Time frame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
Plan to share: Undecided
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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