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

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.

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.