Randomized Controlled Trial on Medically-Graded Honey Supplementation Formula (As a Prebiotic) To Preterm Infants
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The presence of Bifidobacterium bifidum and Lactobacillus spp in Stool
时间窗: Two weeks
Stool culture/ Gram Stain and quantitative real time PCR were used to for this outcome.
次要结局
- Change in Weight (gram)(Baseline and 2 weeks)
- CD4 and CD8 concentration in the serum(2 weeks)
- Change in head circumference (cm)(Baseline and 2 weeks)
- Change in crown-heel length (cm)(Baseline and 2 weeks)
研究者
Reem N. Said
Professor of Pediatrics
Cairo University