NCT05603403

Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Placebo-Controlled Clinical Trial To Evaluate The Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase IV clinical trial that will evaluate the efficacy and safety of Probiatop (investigational product). 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 questionnaire (corresponding to the domains diarrhea, indigestion and constipation) will be randomized to Probiatop or placebo. It will also be applied by electronic means (whatsapp link) on D7, D21 and D35. On these days participants will also be contacted by telemedicine to collect adverse events adverse events and data on concomitant medication. Treatment will be discontinued on D42. On D70 the participant will again be contacted by telemedicine for final data collection. Product under investigation and dosage: Probiatop composition: association of probiotic strains containing 1 g/sachet of 1 x 109 CFU Bifidobacterium lactis HN019 (ATCC SD 5674), 1 x 109 CFU Lactobacillus acidophilus NCFM (ATCC SD 5221), 1 x 109 CFU Lactobacillus rhamnosus HN001 / Lacticaseibacillus rhamnosus HN001 (ATCC SD 5675) and 1 x 109 CFU Lactobacillus paracasei Lpc-37 / Lacticaseibacillus paracasei Lpc-37 (ATCC SD 5275). Placebo composition: collagen

Conditions

• Signs and Symptoms, Digestive

Interventions

Type	Name	Description
DRUG	Probiatop	1 sachet orally, 2 times a day, for 42 days
OTHER	Placebo	1 sachet orally, 2 times a day, for 42 days

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2022-11-02
• Last updated: 2024-03-25

Locations

1 site across 1 country: Brazil