Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

Last updated: March 21, 2024
Sponsor: Azidus Brasil
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

Placebo

Probiatop

Clinical Study ID

NCT05603403
PROFQM0422OR-IV
60215522.6.1001.5412
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 thesum of questions: 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 of the GSRS in frequency orintensity separately.

Exclusion

Exclusion Criteria:

  • Extreme eating habits for which the primary intervention is dietary re-education: morethan 7 of the of the 14 main meals of the week (lunch and dinner) based onultra-processed products (industrial formulations formulations such as: filledcookies, "packaged" snacks packaged" snacks, soft drinks and "instant" noodles, frozenfrozen 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 useof alcohol that lead to clinically significant clinically significant impairmentand/or suffering;
  • Diabetes mellitus type I or II;
  • Chronic diarrhea with signs of malabsorption (weight loss bulky and exceptionallysmelly stools), AND/OR bleeding, AND/OR presence of mucus in the stool, bleedingwithout 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 30days prior to randomization, especially proton pump inhibitors antacids, laxatives,constipating agents (loperamide, racecadotrilla, tricyclic antidepressants), otherprobiotics and prebiotics (containing dietary fiber including inulin, resistantstarch, 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, exceptoperated basal cell carcinoma;
  • History of allergy or hypersensitivity to probiotics or components of the formula;
  • Pregnant and lactating women.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
October 20, 2022
Estimated Completion Date:
March 15, 2023

Study 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

Connect with a study center

  • A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli

    Valinhos, São Paulo 13271-130
    Brazil

    Site Not Available

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