SENeGal SYNbiotic (SENGSYN) Study

Phase 2

• Conditions: Digestive System; Nutritional, Metabolic, Endocrine; Paediatrics

• Registration Number: PACTR202102689928613
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 708

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified