PACTR202102689928613
Other
Phase 2
Dietary supplementation with a synbiotic to improve growth in early life in Senegal: an individually randomised, 2 arm, open-label, controlled study of a synbiotic in infants in Kaffrine District, Senegal.
iverpool School of Tropical Medicine0 sites708 target enrollmentNovember 12, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- iverpool School of Tropical Medicine
- Enrollment
- 708
- Status
- Other
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) singleton newborn
- •2\) birth weight (BW) or current weight (if BW not known) 2000g or more
- •3\) well infant who is breastfed and has taken at least one breastfeed well
- •4\) age 1\-3 days
- •5\) informed consent secured from mother/carer
- •6\) Infants of HIV positive women without known immunosuppression
Exclusion Criteria
- •1\) multiple pregnancy (e.g. twin/triplets)
- •2\) suspicion or presence of any acute illness (e.g. fever, receiving treatment with antibiotics)
- •3\) congenital abnormality that might be life\-threatening or impair growth
- •4\) infant with potential contraindication to synbiotic (e.g. suspected immune suppression; cardiac abnormality)
- •5\) mother unlikely to stay in study area for the duration of the study
- •6\) any health staff or study staff concerns regarding safety to participate in the trial
Outcomes
Primary Outcomes
Not specified
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