Back to resultsEfficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms (Probiatop)
Primary Purpose
Signs and Symptoms, Digestive
Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Probiatop
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Signs and Symptoms, Digestive focused on measuring Signs and Symptoms Digestive, Probiatop, Digestive Symptoms
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.
Sites / Locations
- A2Z Clinical Centro Avancado de Pesquisa Clinica EireliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiatop
Hydrolized collagen
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Clinical Outcome Measure: Efficacy
Multicriteria evaluation of the impact of Probiatop on gastrointestinal symptom reduction symptoms by the Gastrointestinal Symptom Rating Scale (GSRS).
Secondary Outcome Measures
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.
Clinical Outcome Measure: Safety
Incidence and severity of adverse reactions to Probiatop.
Full Information
NCT ID
NCT05603403
First Posted
October 20, 2022
Last Updated
October 31, 2022
Sponsor
Azidus Brasil
Collaborators
Farmoquimica S.A.
1. Study Identification
Unique Protocol Identification Number
NCT05603403
Brief Title
Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms
Acronym
Probiatop
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
December 2, 2022 (Anticipated)
Study Completion Date
January 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
Collaborators
Farmoquimica S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Signs and Symptoms, Digestive
Keywords
Signs and Symptoms Digestive, Probiatop, Digestive Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Investigational product (Probiatop) and Placebo
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiatop
Arm Type
Experimental
Arm Description
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.
Arm Title
Hydrolized collagen
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Probiatop
Other Intervention Name(s)
Probiotic
Intervention Description
1 sachet orally, 2 times a day, for 42 days
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Comparator
Intervention Description
1 sachet orally, 2 times a day, for 42 days
Primary Outcome Measure Information:
Title
Clinical Outcome Measure: Efficacy
Description
Multicriteria evaluation of the impact of Probiatop on gastrointestinal symptom reduction symptoms by the Gastrointestinal Symptom Rating Scale (GSRS).
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Clinical Outcome Measure: Safety
Description
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.
Time Frame
42 days
Title
Clinical Outcome Measure: Safety
Description
Incidence and severity of adverse reactions to Probiatop.
Time Frame
Day 0 to Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Mayumi Doi, MD
Phone
+551938296160
Email
regina@a2zclinical.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Eliane Bottoni, MD
Phone
+551938296160
Email
eliane.bottoni@a2zclinical.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regina Mayumi Doi, MD
Organizational Affiliation
A2Z CLINICAL CENTRO AVANCADO DE PESQUISA CLINICA EIRELI
Official's Role
Principal Investigator
Facility Information:
Facility Name
A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli
City
Valinhos
State/Province
São Paulo
ZIP/Postal Code
13271-130
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Mayumi Doi, MD
Phone
55 19 3829-6160
Email
regina@a2zclinical.com.br
First Name & Middle Initial & Last Name & Degree
Eliane Bottoni, MD
Phone
55 19 3829-6160
Email
eliane.bottoni@a2zclinical.com.br
First Name & Middle Initial & Last Name & Degree
Regina Mayumi Doi, MD
First Name & Middle Initial & Last Name & Degree
Eliane Bottoni, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.
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Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms
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