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

Synbiotec Srl

Status: Completed

Conditions: Microbiota Balance; Gut

Treatments: Dietary Supplement: PROBAFLOR; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06619067

2024/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Treated group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: PROBAFLOR

Placebo group

Placebo Comparator group

Description:

Placebo Placebo product, serving size = 1 capsule/day

Treatment:

Other: Placebo

Sponsor of this trial

Lead Sponsor

Synbiotec Srl