Gut, Microbiota Balance
Conditions
Keywords
Probiotics, Gut health, Microbiota
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPROBAFLOR
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.
OTHERPlacebo
Placebo
Sponsors
Synbiotec Srl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* men and women aged between 18 and 65; * healthy based on medical history; * commitment to comply with all firm procedures; * commitment to refrain from using any home remedies to control gastrointestinal problems, particularly if live bacteria are involved; * signature of informed consent.
Exclusion criteria
* use of probiotics continuously, in the two months prior to enrollment; * use of antibiotics in the month before enrollment; * chemotherapy treatments; * diagnosis of respiratory, hepatic and/or renal failure; * Clinically significant diseases of the gastrointestinal tract (examples include, but are not limited to, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease); * Women who are pregnant, breastfeeding or planning to become pregnant during the study; * Allergy or sensitivity to the active or inactive ingredients of the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maintenance and/or improvement of intestinal health and health-related quality of life (through the GIQLI questionnaire) | Baseline, After 3 months of intervention, at follow-up (one month after the end of administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal microbiota composition | Baseline, After 3 months of intervention, at follow-up (one month after the end of administration | Metagenomic analysis on faecal samples |
| SCFA determination | Baseline, After 3 months of intervention, at follow-up (one month after the end of administration | Gas chromatographic analysis of fecal water |
| Changes in quality of life. | Baseline, After 3 months of intervention, at follow-up (one month after the end of administration | Assessed by PGWBI (The Psychological General Well-Being Index) |
| Changes in intestinal functionality | Baseline, After 3 months of intervention, at follow-up (one month after the end of administration | Assessed in accordance with the Bristol Stool Form Scale |
| Changes on gastrointestinal symptoms | Baseline, After 3 months of intervention, at follow-up (one month after the end of administration | Assessed by the GSRS (Gastrointestinal Symptom Rating Scale) |
Countries
Italy
Outcome results
None listed