Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

Study Overview
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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.

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

Official Title
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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

Conditions
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Signs and Symptoms, Digestive

Intervention / Treatment
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* Drug: Probiatop
* Other: Placebo


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Investigational product (Probiatop) and Placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiatop<br>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<br>* 1 sachet orally, 2 times a day, for 42 days<br>* Other names: Probiotic;|
| Placebo Comparator: Hydrolized collagen<br>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<br>* 1 sachet orally, 2 times a day, for 42 days<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome Measure: Efficacy | 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 | 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 | Incidence and severity of adverse reactions to Probiatop. | Day 0 to Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Signs and Symptoms Digestive, Probiatop, Digestive Symptoms