Clinical trial NCT02679183: Medically-Graded Honey Supplementation Formula To Preterm Infants
Official title: Randomized Controlled Trial on Medically-Graded Honey Supplementation Formula (As a Prebiotic) To Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prebiotics
Honey
Premature Infants
Intestinal Microbiota
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool
timeFrame: Two weeks
Secondary outcomes:
measure: CD4 and CD8 concentration in the serum
timeFrame: 2 weeks
measure: Change in Weight (gram)
timeFrame: Baseline and 2 weeks
measure: Change in crown-heel length (cm)
timeFrame: Baseline and 2 weeks
measure: Change in head circumference (cm)
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.
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. doi: 10.1186/1472-6882-6-6.
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. doi: 10.1016/j.earlhumdev.2006.07.003. Epub 2006 Sep 14.
citation: Aly H, Said RN, Wali IE, Elwakkad A, Soliman Y, Awad AR, Shawky MA, Alam MSA, Mohamed MA. Medically Graded Honey Supplementation Formula to Preterm Infants as a Prebiotic: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):966-970. doi: 10.1097/MPG.0000000000001597.