Status:
COMPLETED
Efficacy of Bifidobacterium Lactis CCT 7858 in Adults Using Antibiotics
Lead Sponsor:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Conditions:
Surgery
Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the effectiveness of the probiotic Bifidobacterium lactis CCT 7858 in preventing and / or improving gastrointestinal symptoms in adults using antibiotics. For this, a randomized, double-bl...
Detailed Description
Two groups (placebo and intervention) will receive supplementation, the Placebo group will receive maltodextrin and Intervention group will receive probiotic B. lactis, that should be consumed for a p...
Eligibility Criteria
Inclusion
- Adults of both sexes;
- Aged between 18 and 65 years;
- 24 hours after starting antibiotic treatment;
- Antibiotics tretament for a minimum of 3 days and a maximum of 14 days;
- Informed consent must be signed before starting the study.
Exclusion
- blood pressure is outside the normal range (systolic blood pressure\> 140, systolic blood pressure \<90, diastolic\> 90);
- history of heart disease, including heart valve disease or heart surgery, any implantable device;
- continuous or recent use of antibiotic therapy in the 30 days prior to the first administration of the study supplement;
- ostomates or users of parenteral nutrition;
- immunosuppressive therapy or any health condition that causes immunosuppression (including hematology malignancies, AIDS);
- Crohn's disease or ulcerative colitis;
- previous infection with Clostridium difficile documented less than 3 months before the start of the study;
- history of daily consumption of probiotics, fermented milk;
- individuals known to have demonstrated a previous reaction, including anaphylaxis, to any substance in the study product composition;
- individuals with active diarrhea (3 or more liquid stools per 24 hour period);
- pregnant women at the time of recruitment or planning to become pregnant during the study;
- Individuals with concomitant participation in another clinical trial.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04742322
Start Date
January 11 2021
End Date
December 30 2021
Last Update
June 10 2022
Active Locations (1)
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1
GABBIA Biotecnologia
Criciúma, Santa Catarina, Brazil, 88390000