Last updated: March 21, 2024
Sponsor: Azidus Brasil
Overall Status: Completed
Phase
4
Condition
N/ATreatment
Placebo
Probiatop
Clinical Study ID
NCT05603403
PROFQM0422OR-IV
60215522.6.1001.5412
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thesum of questions: 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 of the GSRS in frequency orintensity separately.
Exclusion
Exclusion Criteria:
- Extreme eating habits for which the primary intervention is dietary re-education: morethan 7 of the of the 14 main meals of the week (lunch and dinner) based onultra-processed products (industrial formulations formulations such as: filledcookies, "packaged" snacks packaged" snacks, soft drinks and "instant" noodles, frozenfrozen 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 useof alcohol that lead to clinically significant clinically significant impairmentand/or suffering;
- Diabetes mellitus type I or II;
- Chronic diarrhea with signs of malabsorption (weight loss bulky and exceptionallysmelly stools), AND/OR bleeding, AND/OR presence of mucus in the stool, bleedingwithout 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 30days prior to randomization, especially proton pump inhibitors antacids, laxatives,constipating agents (loperamide, racecadotrilla, tricyclic antidepressants), otherprobiotics and prebiotics (containing dietary fiber including inulin, resistantstarch, 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, exceptoperated basal cell carcinoma;
- History of allergy or hypersensitivity to probiotics or components of the formula;
- Pregnant and lactating women.
Study Design
Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
October 20, 2022
Estimated Completion Date:
March 15, 2023
Study Description
Connect with a study center
A2Z Clinical Centro Avancado de Pesquisa Clinica Eireli
Valinhos, São Paulo 13271-130
BrazilSite Not Available
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