Honey, Intestinal Microbiota, Prebiotics, Premature Infants
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMedically-Graded Honey
Honey added to the baby formula once a day for 2 weeks.
OTHERPremature 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Days to 3 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| CD4 and CD8 concentration in the serum | 2 weeks | Serum concentrations of CD4 and CD8 cytokines were measured by by ELISA |
| Change in Weight (gram) | Baseline and 2 weeks | The difference between weight 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 |
| 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 |
Outcome results
None listed