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

NCT ID: NCT06619067

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-03-31

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.

Conditions

Gut; Microbiota Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Treated group

Dietary supplement: PROBAFLOR 20 Billion CFU/dose, serving size = 1 capsule/day

Group Type: ACTIVE_COMPARATOR

PROBAFLOR

Intervention Type: DIETARY_SUPPLEMENT

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 group

Placebo Placebo product, serving size = 1 capsule/day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

PROBAFLOR

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Synbiotec Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Cristina Verdenelli, PhD

Role: STUDY_DIRECTOR

Synbiotec Srl

Locations

Scuola di Bioscienze e Medicina Veterinaria, Università di Camerino

Camerino, Macerata, Italy

Countries

Italy

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Other Identifiers

2024/19

Identifier Type: -

Identifier Source: org_study_id