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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Thrasher Research Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| daily probiotic | Experimental | 10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis daily for one month |
|
| weekly probiotic | Experimental | 10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis weekly for one month |
|
| bi-weekly probiotic | Experimental | 10^8 CFU Lactobacillus reuteri DSM 17938 and 10^9 Bifidobacterium longum infantis bi-weekly for one month |
|
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri DSM 17938 | Dietary Supplement | 10^8 CFU |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yana Emmy E Hoy-Schulz, PhD | Stanford University | Study Director |
| Julie Parsonnet, MD | Stanford University | Principal Investigator |
| Stephen Luby, MD | Stanford University | Principal Investigator |
| Leanne Unicomb, PhD | International Center for Diarrheal Disease Research, Bangladesh | Principal Investigator |
| Kaniz Jannat, MBBS | International Center for Diarrheal Disease Research, Bangladesh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Center for Diarrheal Disease Research, Bangladesh | Dhaka | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30159001 | Derived | Roberts TJ, Hoy-Schulz YE, Jannat K, Parsonnet J. Evidence of inflated exclusive breastfeeding estimates from a clinical trial in Bangladesh. Int Breastfeed J. 2018 Aug 22;13:39. doi: 10.1186/s13006-018-0179-4. eCollection 2018. | |
| 26832746 | Derived | Hoy-Schulz YE, Jannat K, Roberts T, Zaidi SH, Unicomb L, Luby S, Parsonnet J. Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial. BMC Complement Altern Med. 2016 Feb 2;16:44. doi: 10.1186/s12906-016-1016-1. |
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| Bifidobacterium longum infantis | Dietary Supplement | 10^9 CFU |
|
|
| 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 |