Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

Phase 4

Completed

• Conditions: Signs and Symptoms, Digestive
• Interventions: Drug: Probiatop; Other: Placebo

• Registration Number: NCT05603403
• Lead Sponsor: Azidus Brasil

Brief 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

Study Timeline

• Study Start: 2022-10-20
• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-02
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiatop	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.
Hydrolized collagen	Placebo	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome Measure: Safety	Day 0 to Day 42	Incidence and severity of adverse reactions to Probiatop.

Trial Locations

Locations (1)

A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli; 🇧🇷 Valinhos, São Paulo, Brazil