Safety and Efficacy of Probiotics in Bangladeshi Infants

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Probiotics in Bangladeshi Infants

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri DSM 17938
* Dietary Supplement: Bifidobacterium longum infantis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: daily probiotic<br>10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis daily for one month | Dietary Supplement: Lactobacillus reuteri DSM 17938<br>* 10^8 CFU<br>* Other names: BioGaia Protectis Baby;Dietary Supplement: Bifidobacterium longum infantis<br>* 10^9 CFU<br>* Other names: Align;|
| Experimental: weekly probiotic<br>10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis weekly for one month | Dietary Supplement: Lactobacillus reuteri DSM 17938<br>* 10^8 CFU<br>* Other names: BioGaia Protectis Baby;Dietary Supplement: Bifidobacterium longum infantis<br>* 10^9 CFU<br>* Other names: Align;|
| Experimental: bi-weekly probiotic<br>10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis bi-weekly for one month | Dietary Supplement: Lactobacillus reuteri DSM 17938<br>* 10^8 CFU<br>* Other names: BioGaia Protectis Baby;Dietary Supplement: Bifidobacterium longum infantis<br>* 10^9 CFU<br>* Other names: Align;|
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of probiotic in the stool | presence of absence of each probiotic in the stool | weeks 0-12 | 
| Adverse events | Any adverse or allergic reactions after probiotic administration, hospitalizations, GI and respiratory symptoms | duration of study - through study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantity of probiotic in the stool | amount of each probiotic present in the stool | weeks 0-12 | 
| composition of microbiota | microbial community composition | weeks 0-12 | 
| clinical effects | fever, diarrhea, wheezing, rash, stool frequency, feeding frequency | daily for 7 days after first probiotic administration, then weeks 2-12 | 
| gut function | lactulose/mannitol ratio | months 0, 1, 2, 3 | 
| gut inflammation | fecal neopterin, alpha-1 antitrypsin, and myeloperoxidase - correlated with future growth | months 0,1,2,3 | 
| gut inflammation/translocation | IL22, CD-14, total IgG and c-reactive protein | months 0, 1, 2, 3 | 
| growth | weight, length, head circumference | month 0, 1, 2, 3 | 
| breastfeeding rates |  | month 0, 1, 2, 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics