Clinical trial NCT06619067: Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being
Official title: Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being: Single-centre, Controlled, Randomized, Parallel Group, Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut
Microbiota Balance
Keywords: Probiotics
Gut health
Microbiota
Lead sponsor: Synbiotec Srl
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: maintenance and/or improvement of intestinal health and health-related quality of life (through the GIQLI questionnaire)
timeFrame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
Secondary outcomes:
measure: Intestinal microbiota composition
timeFrame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
measure: SCFA determination
timeFrame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
measure: Changes in quality of life.
timeFrame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
measure: Changes in intestinal functionality
timeFrame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
measure: Changes on gastrointestinal symptoms
timeFrame: Baseline, After 3 months of intervention, at follow-up (one month after the end of administration
Other outcomes:
Locations:
city: Camerino
country: Italy
facility: Scuola di Bioscienze e Medicina Veterinaria, Università di Camerino
state: Macerata
Study officials:
affiliation: Synbiotec Srl
name: Maria Cristina Verdenelli, PhD
role: STUDY_DIRECTOR
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