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Medically-Graded Honey Supplementation Formula To Preterm Infants (Honey)

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ClinicalTrials.gov Identifier: NCT02679183
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Reem N. Said, Cairo University

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.

Condition or disease Intervention/treatment Phase
Prebiotics Honey Premature Infants Intestinal Microbiota Dietary Supplement: Medically-Graded Honey Other: Premature Milk Formula Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Randomized Controlled Trial on Medically-Graded Honey Supplementation Formula (As a Prebiotic) To Preterm Infants
Study Start Date : January 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Placebo Comparator: Control 0
No Intervention. This group received Premature Milk Formula. This group did not receive any Medically-Graded Honey.
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.

Experimental: Group 1
This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 5 gram/day) for 2 weeks
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.

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

Experimental: Group 3
This group received Premature Milk Formula. This group received Medically-Graded Honey (dose = 15 gram/day) for 2 weeks
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. CD4 and CD8 concentration in the serum [ Time Frame: 2 weeks ]
    Serum concentrations of CD4 and CD8 cytokines were measured by by ELISA

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   up to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Reem N. Said, Professor of Pediatrics, Cairo University
ClinicalTrials.gov Identifier: NCT02679183    
Other Study ID Numbers: 100904
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016