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Updated: Sep 17, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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A Longitudinal Observational Study of a Powder-Based Supplement for a Future Synbiotic Trial in Breastfed Children

Rupak Shivakoti1, Barbara Laughton2, Mehr Shafiq1

  • 1Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, NY, USA.

Sage Open Pediatrics
|July 4, 2025
PubMed

This study investigates the feasibility and acceptability of a powder-based supplement for breastfeeding HIV-exposed uninfected children to inform a larger trial (MIGH-T MO study). Ten mothers living with HIV and their children (6 weeks-20 months) at Tygerberg Hospital, Cape Town, South Africa, participated. The children received a daily supplement of potato maltodextrin mixed with expressed breast milk for 4 weeks, serving as a placebo control for the upcoming trial. Outcomes assessed included feasibility, acceptability, adherence, and health effects, evaluated at enrollment, during weekly calls, and at the 4-week visit. High acceptability was indicated by full enrollment of eligible participants, though there was some loss to follow-up (n = 3). Among the remaining participants, no major feasibility issues were found regarding procedures, product administration, adherence, tolerance, or health assessments. The study concludes that powder-based supplements are feasible and acceptable for breastfeeding HEU children, supporting the potential for larger studies using similar supplements.

Keywords:
HMObreastmilkchild morbidityfeasibilitysynbiotic

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