Efficacy of Bifidobacterium Lactis CCT 7858 in Adults Using Antibiotics

NCT04742322 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-06-10

No results posted yet for this study

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-blind, placebo-controlled clinical trial will be carried out. The sample will be composed of adults who will be recruited in a hospital, who have been hospitalized and receive a prescription for antibiotics. The individuals will be separated into two groups: intervention and placebo. 104 patients will be included, 52 for each group. Inclusion criteria:

adults of both sexes and aged between 18 and 65 years, who have been recruited within 24 hours after starting antibiotic treatment, the prescribed treatment should be with antibiotics for a minimum of 9 days and a maximum of 14 days. The informed consent must be signed before starting the study.

Conditions

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium Lactis CCT7858

Probiotic B Lactis

DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin

Sponsors & Collaborators

  • Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2021-01-11
Completion
2021-12-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742322 on ClinicalTrials.gov