Medically-Graded Honey Supplementation Formula To Preterm Infants

Cairo University (CU)

Status and phase: Completed; Early Phase 1

Conditions: Premature Infants; Intestinal Microbiota; Prebiotics; Honey

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02679183

100904

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 3 days to 3 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

Control 0

Placebo Comparator group

Description:

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

Treatment:

Other: Premature Milk Formula

Group 1

Experimental group

Description:

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

Treatment:

Dietary Supplement: Medically-Graded Honey

Other: Premature Milk Formula

Group 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: Medically-Graded Honey

Other: Premature Milk Formula

Group 3

Experimental group

Description:

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

Treatment:

Dietary Supplement: Medically-Graded Honey

Other: Premature Milk Formula