Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms
Status:
Recruiting
Trial end date:
2023-01-20
Target enrollment:
Participant gender:
Summary
A Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the
Efficacy and Safety of Probiatop in the Treatment of Digestive Symptoms. Phase IV. The
casuistic presented in this protocol is 150 participants randomized at a 1:1 ratio (75
receiving Probiatop and 75 receiving placebo), balanced by age, sex, prebiotic intake* and
summation of the Gastrointestinal Symptom Rating Scale (GSRS) questions related to the
domains of diarrhea (questions 11, 12, and 14), indigestion (questions 6, 7, 8, and 9), and
constipation (questions 10, 13, and 15) separated by intensity and frequency. Participants
with recurrent digestive symptoms for at least 3 months, with a score of 21 on the sum of
questions 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15 of the GSRS (corresponding to the domains
diarrhea, indigestion and constipation) will be randomized to Probiatop or placebo.