Clinical trial NCT05603403: Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Signs and Symptoms, Digestive
Keywords: Signs and Symptoms Digestive
Probiatop
Digestive Symptoms
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Farmoquimica S.A.
First posted: 2022-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigational product (Probiatop) and Placebo
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Outcome Measure: Efficacy
timeFrame: 42 days
Secondary outcomes:
measure: Clinical Outcome Measure: Safety
timeFrame: 42 days
measure: Clinical Outcome Measure: Safety
timeFrame: Day 0 to Day 42
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli
state: São Paulo
Study officials:
affiliation: A2Z CLINICAL CENTRO AVANCADO DE PESQUISA CLINICA EIRELI
name: Regina Mayumi Doi, MD
role: PRINCIPAL_INVESTIGATOR
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