Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms (Probiatop)

March 21, 2024 updated by: Azidus Brasil

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Valinhos, São Paulo, Brazil, 13271-130
        • A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female gender;
  • Age ≥ 18 years;
  • BMI ≥ 18, 5 ≤ 29.9 Kg/m2;
  • Complaint of recurrent digestive symptoms for at least 3 months with value ≥ 21 of the sum of questions: 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 of the GSRS in frequency or intensity separately.

Exclusion Criteria:

  • Extreme eating habits for which the primary intervention is dietary re-education: more than 7 of the of the 14 main meals of the week (lunch and dinner) based on ultra-processed products (industrial formulations formulations such as: filled cookies, "packaged" snacks packaged" snacks, soft drinks and "instant" noodles, frozen frozen and ready-to-eat products such as pasta, pizzas hamburgers, nuggets, sausages, etc) or "fast food" or average consumption of soft drinks exceeding 2 glasses per day.
  • Alcoholism (DSM V): disorder defined as the repetition problems resulting from the use of alcohol that lead to clinically significant clinically significant impairment and/or suffering;
  • Diabetes mellitus type I or II;
  • Chronic diarrhea with signs of malabsorption (weight loss bulky and exceptionally smelly stools), AND/OR bleeding, AND/OR presence of mucus in the stool, bleeding without diarrhea;
  • Weight loss ≥ 10% in the past 6 months;
  • Any recent change in eating habit, including veganism;
  • Clinically significant illnesses at the discretion of the Investigator;
  • Use of medications or supplements that may modify gastrointestinal function in the 30 days prior to randomization, especially proton pump inhibitors antacids, laxatives, constipating agents (loperamide, racecadotrilla, tricyclic antidepressants), other probiotics and prebiotics (containing dietary fiber including inulin, resistant starch, cellulose, oligofructose, fiber oligofructose, soy fiber, polydextrose, Kefir, Kombucha, and others);
  • Use of antibiotics in the 3 months prior to randomization for any indications, including Helicobacter pylori;
  • History of digestive surgery;
  • Active cancer or cancer under treatment in the 6 months prior to randomization, except operated basal cell carcinoma;
  • History of allergy or hypersensitivity to probiotics or components of the formula;
  • Pregnant and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiatop

Probiotic used in the reconstitution and rebalancing of the intestinal microbiota.

Association of probiotic strains containing 1 g/sachet of 1 x 109 Bifidobacterium lactis HN019, 1 x 109 Lactobacillus acidophilus, 1 x 109 Lactobacillus rhamnosus HN001 / Lacticaseibacillus rhamnosus HN001 and 1 x 109 Lactobacillus paracasei Lpc- 37 / Lacticaseibacillus paracasei Lpc-37.
Drug: Probiatop
1 sachet orally, 2 times a day, for 42 days
Other Names:
  • Probiotic
Placebo Comparator: Hydrolized collagen
Hydrolyzed collagen is approved by Agência Nacional de Vigilância Sanitária (ANVISA) including for use in infants (ANVISA, IN NO. 28, OF JULY 26, 2018). Its use as a placebo is convenient, as it dissolves well in water, and promotes good masking. Based on literature surveys on hydrolyzed collagen and the intestinal microbiota, it was verified that the dose used (1 g) would not promote relevant functional impact in the context of the habitual Brazilian people diet.
Other: Placebo
1 sachet orally, 2 times a day, for 42 days
Other Names:
  • Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome Measure: Efficacy
Time Frame: 42 days
Multicriteria evaluation of the impact of Probiatop on gastrointestinal symptom reduction symptoms by the Gastrointestinal Symptom Rating Scale (GSRS).
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome Measure: Safety
Time Frame: 42 days
Evaluation of the impact of Probiatop on the reduction of each domain of the questionnaire Gastrointestinal Symptom Rating Scale (GSRS) - abdominal pain, reflux syndrome, diarrhea, indigestion and constipation.
42 days
Clinical Outcome Measure: Safety
Time Frame: Day 0 to Day 42
Incidence and severity of adverse reactions to Probiatop.
Day 0 to Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Collaborators

Farmoquimica S.A.

Investigators

  • Principal Investigator: Regina Mayumi Doi, MD, A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 31, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROFQM0422OR-IV
  • 60215522.6.1001.5412 (Other Identifier: CAAE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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