Medically-Graded Honey Supplementation Formula To Preterm Infants

NCT ID: NCT02679183

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Control 0

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

Group Type: PLACEBO_COMPARATOR

Premature Milk Formula

Intervention Type: 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.

Group 1

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

Group Type: EXPERIMENTAL

Medically-Graded Honey

Intervention Type: DIETARY_SUPPLEMENT

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

Premature Milk Formula

Intervention Type: 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.

Group 2

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

Group Type: EXPERIMENTAL

Medically-Graded Honey

Intervention Type: DIETARY_SUPPLEMENT

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

Premature Milk Formula

Intervention Type: 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.

Group 3

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

Group Type: EXPERIMENTAL

Medically-Graded Honey

Intervention Type: DIETARY_SUPPLEMENT

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

Premature Milk Formula

Intervention Type: 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.

Interventions

Medically-Graded Honey

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 3 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Reem N. Said

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 24476663 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23997898 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16533410 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16978805 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28379925 (View on PubMed)

Other Identifiers

100904

Identifier Type: -

Identifier Source: org_study_id