Safety and Efficacy of Probiotics in Bangladeshi Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Probiotics on the Digestibility and Immunity in Infants

NCT02317406

Gastrointestinal Tract Flora Composition

COMPLETED NA

Pilot of a Prebiotic and Probiotic Trial in Young Infants With Severe Acute Malnutrition

NCT03666572

Severe Acute Malnutrition

COMPLETED PHASE2

Study the Safety and Efficacy of Probiotics Use in Premature Infants

NCT01891604

Infant, Premature, Diseases

WITHDRAWN NA

Safety and Tolerance Study of Three Probiotic Strains in Infants

NCT02215304

Body Weight Body Height Head Circumference

COMPLETED NA

Effect of Probiotic Supplementation on Immune Function in Healthy Infants

NCT01542320

Inflammation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

daily probiotic

10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis daily for one month

Group Type EXPERIMENTAL

Lactobacillus reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

10\^8 CFU

Bifidobacterium longum infantis

Intervention Type DIETARY_SUPPLEMENT

10\^9 CFU

weekly probiotic

10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis weekly for one month

Group Type EXPERIMENTAL

Lactobacillus reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

10\^8 CFU

Bifidobacterium longum infantis

Intervention Type DIETARY_SUPPLEMENT

10\^9 CFU

bi-weekly probiotic

10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis bi-weekly for one month

Group Type EXPERIMENTAL

Lactobacillus reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

10\^8 CFU

Bifidobacterium longum infantis

Intervention Type DIETARY_SUPPLEMENT

10\^9 CFU

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus reuteri DSM 17938

10\^8 CFU

Intervention Type DIETARY_SUPPLEMENT

Bifidobacterium longum infantis

10\^9 CFU

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BioGaia Protectis Baby Align

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy infants.
* Infants 1 -3 months of age at the beginning of the study.
* Parents/guardians of each subject are able to understand study procedures and agree to participate in the study by giving consent.
* Parents and child are planning to remain in Dhaka for the next four months.

Exclusion Criteria

* Infants with known birth defects.
* Infants who have been hospitalized.
* Infants who have an acute infection or illness at the time of enrolment.
* Infants who are currently taking antibiotics
* Infants \<1 month of age or \>3 months of age.
* Infants three standard deviations below mean on anthropometric measures (will be referred for medical care).
* Infants who are already receiving a probiotic product or treatment.
* A diagnosis or suspicion of immunodeficiency disorder.
* A diagnosis or suspicion of bleeding disorder that would contraindicate venipuncture.
* Family residence outside of Dhaka or families expecting to move outside of Dhaka in the next 4 months.

Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes