NCT02679183

Medically-Graded Honey Supplementation Formula To Preterm Infants

Randomized Controlled Trial on Medically-Graded Honey Supplementation Formula (As a Prebiotic) To Preterm Infants

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 3 Days – 3 Weeks
• Healthy volunteers: Not accepted

Summary

Honey is a natural product that contains multiple nutrients; it is composed of fructose, glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also contains more than 180 substances including amino acids, vitamins, minerals and enzymes. Investigators hypothesized that supplementation of enteral feeds with honey would produce a bifidogenic effect and stimulate the immune response in preterm infants. Investigators randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2 weeks and measured their effect on stool colonization, systemic immune parameters and anthropometric measurements.

Conditions

• Prebiotics
• Honey
• Premature Infants
• Intestinal Microbiota

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Medically-Graded Honey	Honey added to the baby formula once a day for 2 weeks.
OTHER	Premature Milk Formula	Enteral feeds were provided to subjects of all groups using premature milk formula as per routine nutritional management in the neonatal intensive care unit.

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2016-02-10
• Last updated: 2016-02-10