Medically-Graded Honey Supplementation Formula To Preterm Infants

Early Phase 1

Completed

• Conditions: Intestinal Microbiota; Prebiotics; Honey; Premature Infants
• Interventions: Other: Premature Milk Formula; Dietary Supplement: Medically-Graded Honey

• Registration Number: NCT02679183
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-09
• Last Update Submitted: 2016-02-09
• Study First Posted: 2016-02-10
• Last Update Posted: 2016-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• preterm infants with gestational age ≤ 34 weeks
• postnatal age > 3 days
• no previous enteral feeding, and
• parental wish to use milk formula with no intention to use breast milk or breastfeed.

Exclusion Criteria

• infants with major chromosomal abnormalities
• Infant with major congenital anomalies of the cardiovascular, pulmonary or central nervous system; including neuromuscular disorders and neural tube defects
• infants with intestinal atresia, tracheoesophageal fistulas, omphalocele, gastroschisis, and other major congenital GI anomalies, and
• infants with sepsis, either before or during enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control 0	Premature Milk Formula	No Intervention. This group received Premature Milk Formula. This group did not receive any Medically-Graded Honey.
Group 1	Medically-Graded Honey	This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 5 gram/day) for 2 weeks
Group 1	Premature Milk Formula	This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 5 gram/day) for 2 weeks
Group 2	Medically-Graded Honey	This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 10 gram/day) for 2 weeks
Group 3	Medically-Graded Honey	This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 15 gram/day) for 2 weeks
Group 3	Premature Milk Formula	This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 15 gram/day) for 2 weeks
Group 2	Premature Milk Formula	This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 10 gram/day) for 2 weeks

Primary Outcome Measures

Name	Time	Method
The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool	Two weeks	Stool culture/ Gram Stain and quantitative real time PCR were used to for this outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Weight (gram)	Baseline and 2 weeks	The difference between weight at enrollment and at 2 weeks was measured for all subjects
CD4 and CD8 concentration in the serum	2 weeks	Serum concentrations of CD4 and CD8 cytokines were measured by by ELISA
Change in head circumference (cm)	Baseline and 2 weeks	The difference between head circumference at enrollment and at 2 weeks was measured for all subjects
Change in crown-heel length (cm)	Baseline and 2 weeks	The difference between the length at enrollment and at 2 weeks was measured for all subjects