Medically-Graded Honey Supplementation Formula To Preterm Infants

Overview

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.

Full Title of Study: “Randomized Controlled Trial on Medically-Graded Honey Supplementation Formula (As a Prebiotic) To Preterm Infants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2014

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • CD4 and CD8 concentration in the serum
    • Time Frame: 2 weeks
    • Serum concentrations of CD4 and CD8 cytokines were measured by by ELISA
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Days

Maximum Age: 3 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Reem N. Said, Professor of Pediatrics – Cairo University

Citations Reporting on Results

Boyar V, Handa D, Clemens K, Shimborske D. Clinical experience with Leptospermum honey use for treatment of hard to heal neonatal wounds: case series. J Perinatol. 2014 Feb;34(2):161-3. doi: 10.1038/jp.2013.158.

Eteraf-Oskouei T, Najafi M. Traditional and modern uses of natural honey in human diseases: a review. Iran J Basic Med Sci. 2013 Jun;16(6):731-42.

Ezz El-Arab AM, Girgis SM, Hegazy EM, Abd El-Khalek AB. Effect of dietary honey on intestinal microflora and toxicity of mycotoxins in mice. BMC Complement Altern Med. 2006 Mar 14;6:6.

Kapiki A, Costalos C, Oikonomidou C, Triantafyllidou A, Loukatou E, Pertrohilou V. The effect of a fructo-oligosaccharide supplemented formula on gut flora of preterm infants. Early Hum Dev. 2007 May;83(5):335-9. Epub 2006 Sep 14.

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