Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being

Not Applicable

Completed

• Conditions: Gut; Microbiota Balance
• Interventions: Dietary Supplement: PROBAFLOR; Other: Placebo

• Registration Number: NCT06619067
• Lead Sponsor: Synbiotec Srl

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.

Study Timeline

• Study Start: 2024-07-01
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-27
• Study First Posted: 2024-10-01
• Status Verified: 2025-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-31
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated group	PROBAFLOR	Dietary supplement: PROBAFLOR 20 Billion CFU/dose, serving size = 1 capsule/day
Placebo group	Placebo	Placebo Placebo product, serving size = 1 capsule/day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Scuola di Bioscienze e Medicina Veterinaria, Università di Camerino; 🇮🇹 Camerino, Macerata, Italy