Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms
NCT ID: NCT05603403
Last Updated: 2024-03-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
150 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-10-20
Study Completion Date
2023-03-15
Brief Summary
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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.
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Detailed Description
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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
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
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Signs and Symptoms, Digestive
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Investigational product (Probiatop) and Placebo
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
The study will be double-blind. The participants and the investigator will be "blinded" in the study, in which they will not know the treatment that each participant will be receiving.
Study Groups
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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.
Group Type
EXPERIMENTAL
Probiatop
Intervention Type
DRUG
1 sachet orally, 2 times a day, for 42 days
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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
1 sachet orally, 2 times a day, for 42 days
Interventions
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Probiatop
1 sachet orally, 2 times a day, for 42 days
Intervention Type
DRUG
Placebo
1 sachet orally, 2 times a day, for 42 days
Intervention Type
OTHER
Other Intervention Names
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Probiotic
Placebo Comparator
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Farmoquimica S.A.
INDUSTRY
Sponsor Role
collaborator
Azidus Brasil
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Regina Mayumi Doi, MD
Role: PRINCIPAL_INVESTIGATOR
A2Z CLINICAL CENTRO AVANCADO DE PESQUISA CLINICA EIRELI
Locations
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A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli
Valinhos, São Paulo, Brazil
Site Status
Countries
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Brazil
References
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Other Identifiers
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60215522.6.1001.5412
Identifier Type: OTHER
Identifier Source: secondary_id
PROFQM0422OR-IV
Identifier Type: -
Identifier Source: org_study_id
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