Medically-Graded Honey Supplementation Formula To Preterm Infants

Premature Infants Clinical Trial

— Honey  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679183
• Other study ID #: 100904
• Status: Completed
• Phase: Phase 0
• First received: February 3, 2016
• Last updated: February 9, 2016
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: February 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Egyptian Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Honey
• Intestinal Microbiota
• Prebiotics
• Premature Infants

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool	Stool culture/ Gram Stain and quantitative real time PCR were used to for this outcome.	Two weeks	Yes
Secondary	CD4 and CD8 concentration in the serum	Serum concentrations of CD4 and CD8 cytokines were measured by by ELISA	2 weeks	Yes
Secondary	Change in Weight (gram)	The difference between weight at enrollment and at 2 weeks was measured for all subjects	Baseline and 2 weeks	No
Secondary	Change in crown-heel length (cm)	The difference between the length at enrollment and at 2 weeks was measured for all subjects	Baseline and 2 weeks	No
Secondary	Change in head circumference (cm)	The difference between head circumference at enrollment and at 2 weeks was measured for all subjects	Baseline and 2 weeks	No