Skip to main content
OpenTrials
Completed

NCT Number: NCT02679183

Medically-Graded Honey Supplementation Formula To Preterm Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prebiotics Female Urogenital Diseases and Pregnancy Complications Honey Intestinal Microbiota Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Infants Urogenital Diseases

Age range

3 day–3 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medically-Graded Honey

Dietary Supplement

Honey added to the baby formula once a day for 2 weeks.

Premature Milk Formula

Other

Enteral feeds were provided to subjects of all groups using premature milk formula as per routine nutritional management in the neonatal intensive care unit.

Primary outcomes

  1. The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool

    Time frame: Two weeks

    Stool culture/ Gram Stain and quantitative real time PCR were used to for this outcome.

Secondary outcomes

  1. CD4 and CD8 concentration in the serum

    Time frame: 2 weeks

    Serum concentrations of CD4 and CD8 cytokines were measured by by ELISA

  2. Change in Weight (gram)

    Time frame: Baseline and 2 weeks

    The difference between weight at enrollment and at 2 weeks was measured for all subjects

  3. Change in crown-heel length (cm)

    Time frame: Baseline and 2 weeks

    The difference between the length at enrollment and at 2 weeks was measured for all subjects

  4. Change in head circumference (cm)

    Time frame: Baseline and 2 weeks

    The difference between head circumference at enrollment and at 2 weeks was measured for all subjects

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: Honey

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 10, 2016
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.