Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms

NCT05603403 | Completed Phase 4 DMC

• 2 other identifiers: PROFQM0422OR-IV60215522.6.1001.5412
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Signs and Symptoms, Digestive

Keywords

Signs and Symptoms Digestive; Probiatop; Digestive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Outcome Measure: Safety

  42 days

• Clinical Outcome Measure: Safety

  Day 0 to Day 42

Study Arms (2)

Probiatop

EXPERIMENTAL

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

Hydrolized collagen

PLACEBO COMPARATOR

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

Interventions

Probiatop DRUG

1 sachet orally, 2 times a day, for 42 days

Also known as: Probiotic

Probiatop

Placebo OTHER

1 sachet orally, 2 times a day, for 42 days

Also known as: Placebo Comparator

Hydrolized collagen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azidus Brasil: lead
• Farmoquimica S.A.: collaborator

Study Sites (1)

A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli

Valinhos, São Paulo, 13271-130, Brazil

Location

Related Publications (37)

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MeSH Terms

Conditions

Signs and Symptoms, Digestive

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Regina Mayumi Doi, MD

  A2Z CLINICAL CENTRO AVANCADO DE PESQUISA CLINICA EIRELI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Investigational product (Probiatop) and Placebo

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 2, 2022
• Study Start: October 20, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)