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Safety and Efficacy of Probiotics in Bangladeshi Infants

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Stanford University

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Dietary Supplement: Bifidobacterium longum infantis
Dietary Supplement: Lactobacillus reuteri DSM 17938

Study type

Interventional

Funder types

Other

Identifiers

NCT01899378
SPO109949

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

1 to 3 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 4 patient groups

daily probiotic
Experimental group
Description:
10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis daily for one month
Treatment:
Dietary Supplement: Bifidobacterium longum infantis
Dietary Supplement: Lactobacillus reuteri DSM 17938
weekly probiotic
Experimental group
Description:
10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis weekly for one month
Treatment:
Dietary Supplement: Bifidobacterium longum infantis
Dietary Supplement: Lactobacillus reuteri DSM 17938
bi-weekly probiotic
Experimental group
Description:
10\^8 CFU Lactobacillus reuteri DSM 17938 and 10\^9 Bifidobacterium longum infantis bi-weekly for one month
Treatment:
Dietary Supplement: Bifidobacterium longum infantis
Dietary Supplement: Lactobacillus reuteri DSM 17938
control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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