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Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

NCT05603403 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-25

No results posted yet for this study

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.

Conditions

  • Signs and Symptoms, Digestive

Interventions

DRUG

Probiatop

1 sachet orally, 2 times a day, for 42 days

OTHER

Placebo

1 sachet orally, 2 times a day, for 42 days

Sponsors & Collaborators

  • Farmoquimica S.A.

    collaborator INDUSTRY

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

  • Regina Mayumi Doi, MD · A2Z CLINICAL CENTRO AVANCADO DE PESQUISA CLINICA EIRELI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2023-03-15
Completion
2023-03-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05603403 on ClinicalTrials.gov