NCT06283784

Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients

Double Blind, Randomized, Placebo Controlled Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics in the Prophylaxis Of Diarrhea In Adult Patients Who Already Initiated An Oral Antibiotic Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Biofarma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days. The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days)

Detailed description

AAD is defined as clinically unexplained diarrhea that occurs in connection with antibiotic administration. Any antibiotic could potentially cause AAD, but broad-spectrum antibiotics that predominantly target anaerobes and are poorly absorbed, such as clindamycin, cephalosporins (cefixime and ceftriaxone), and amoxicillin-clavulanate, have a higher AAD incidence (Turck D, 2003). It has been reported that the highest rates of AAD in 650 pediatric cases were associated with amoxicillin/clavulanate (23%), penicillin A or M (11%) and erythromycin (16%). In the present trial, adult population already under antibiotic therapy with ampicillin/amoxicillin, cephalosporins and clindamycin, will be selected, in order to capture the highest possible diarrhea events, with a limited number of subjects. YOVIS, the Investigational Food Supplement (IFS), is an oral formulation (capsules) containing definite mix of live probiotics already marketed by Alfa-Sigma as food supplement since September 2017. Placebo is an oral formulation of inert capsules. Placebo and YOVIS are identical in shape, size, colour and taste. One-hundred (100) subjects will be randomized to receive either YOVIS or placebo (1:1) over a period of 10 days. In case all inclusion/exclusion criteria are met, the subject will be randomized at the baseline visit to one of two masked trial treatments. Further phone contacts are scheduled on day 10±2 and day 21±2, a final visit at site is scheduled on day 28±2. The primary objective of this study is to assess, versus placebo, the efficacy of a 10 days treatment with YOVIS in preventing the incidence of AAD in subjects under antibiotic therapy.

Conditions

• Diarrhea

Interventions

Type	Name	Description
OTHER	Yovis Capsules	Subjects will assume the active treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
OTHER	Placebo	Subjects will assume the placebo treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.

Timeline

• Start date: 2021-09-05
• Primary completion: 2021-11-02
• Completion: 2022-05-18
• First posted: 2024-02-28
• Last updated: 2024-03-18

Locations

1 site across 1 country: Italy