Efficacy of Bifidobacterium Lactis CCT 7858 in Adults Using Antibiotics

NCT04742322 | Completed Phase 2 DMC

• 1 other identifier: 40641120900005364
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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-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

Surgery; Infection

Keywords

probiotic; antibiotic; B lactis

Outcome Measures

Primary Outcomes (1)

• Decreased diarrhea

  Decreased diarrhea through bristol scale. The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Categories: 1 - 7

  10 - 14 days

Secondary Outcomes (2)

• Improve in Quality of life

  10-14 days

• Improve of gastrointestinal symptoms

  10 - 14 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1x capsule/day - maltodextrin, period of 10 to 14 days

Dietary Supplement: Maltodextrin

B Lactis

EXPERIMENTAL

1x capsule/day - 9x10x10 UFC, period of 10 to 14 days

Dietary Supplement: Bifidobacterium Lactis CCT7858

Interventions

Bifidobacterium Lactis CCT7858 DIETARY_SUPPLEMENT

Probiotic B Lactis

B Lactis

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

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

You may qualify if:

• Adults of both sexes;
• Aged between 18 and 65 years;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

GABBIA Biotecnologia

Criciúma, Santa Catarina, 88390000, Brazil

Location

MeSH Terms

Conditions

Infections

Interventions

maltodextrin

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 8, 2021
• Study Start: January 11, 2021
• Primary Completion: January 11, 2021
• Study Completion: December 30, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

BR (1)