Medically-Graded Honey Supplementation Formula To Preterm Infants

NCT02679183 | Completed Early Phase 1

• 1 other identifier: 100904
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prebiotics; Honey; Premature Infants; Intestinal Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• CD4 and CD8 concentration in the serum

  2 weeks

• Change in Weight (gram)

  Baseline and 2 weeks

• Change in crown-heel length (cm)

  Baseline and 2 weeks

• Change in head circumference (cm)

  Baseline and 2 weeks

Study Arms (4)

Control 0

PLACEBO COMPARATOR

No Intervention. This group received Premature Milk Formula. This group did not receive any Medically-Graded Honey.

Other: Premature Milk Formula

Group 1

EXPERIMENTAL

This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 5 gram/day) for 2 weeks

Dietary Supplement: Medically-Graded Honey; Other: Premature Milk Formula

Group 2

EXPERIMENTAL

This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 10 gram/day) for 2 weeks

Dietary Supplement: Medically-Graded Honey; Other: Premature Milk Formula

Group 3

EXPERIMENTAL

This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 15 gram/day) for 2 weeks

Dietary Supplement: Medically-Graded Honey; Other: Premature Milk Formula

Interventions

Medically-Graded Honey DIETARY_SUPPLEMENT

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

Group 1; Group 2; Group 3

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.

Control 0; Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 3 Days - 3 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• 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.

  PMID: 24476663 RESULT

• 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.

  PMID: 23997898 RESULT

• 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.

  PMID: 16533410 RESULT

• 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.

  PMID: 16978805 RESULT

• 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.

  PMID: 28379925 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 10, 2016
• Study Start: January 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 10, 2016

Record last verified: 2016-02