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Completed

NCT Number: NCT01899378

Safety and Efficacy of Probiotics in Bangladeshi Infants

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.

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Key information

Conditions

Healthy

Age range

1 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

International Center for Diarrheal Disease Research, Bangladesh

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus reuteri DSM 17938

Dietary Supplement

10^8 CFU

Other names: BioGaia Protectis Baby

Bifidobacterium longum infantis

Dietary Supplement

10^9 CFU

Other names: Align

Primary outcomes

  1. Presence of probiotic in the stool

    Time frame: weeks 0-12

    presence of absence of each probiotic in the stool

  2. Adverse events

    Time frame: duration of study - through study completion

    Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms

Secondary outcomes

  1. quantity of probiotic in the stool

    Time frame: weeks 0-12

    amount of each probiotic present in the stool

  2. composition of microbiota

    Time frame: weeks 0-12

    microbial community composition

  3. clinical effects

    Time frame: daily for 7 days after first probiotic administration, then weeks 2-12

    fever, diarrhea, wheezing, rash, stool frequency, feeding frequency

  4. gut function

    Time frame: months 0, 1, 2, 3

    lactulose/mannitol ratio

  5. gut inflammation

    Time frame: months 0,1,2,3

    fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth

  6. gut inflammation/translocation

    Time frame: months 0, 1, 2, 3

    IL22, CD-14, total IgG and c-reactive protein

  7. growth

    Time frame: month 0, 1, 2, 3

    weight, length, head circumference

  8. breastfeeding rates

    Time frame: month 0, 1, 2, 3

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh
  • Thrasher Research Fund

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2013
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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