Safety Assessment of a Starter Formula Containing D-lactate Producing Probiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- D-lactic acid urine measure in babies
研究概览
简要总结
In this study the investigators want to test the safety of D-lactate producing probiotics in babies from birth to 1 month of age. Previous data demonstrated no increase in urinary D-lactate in 4 month old infants supplemented with D-lactate producing probiotics. The primary purpose of this study is to evaluate the influence of D-lactate producing probiotics on D-lactate excretion in young infants during the neonatal period (days 0 - 28).
详细描述
Lactate, in addition to being found in more common fermented foods of today, such as yogurt, lactate, in its two stereoisomer forms, known as the D (dextrorotary) or L (levorotary) is also produced in the colon through the normal fermentative process of lactic acid producing bacteria. Both D-lactate and L-lactate produced by these microbes are metabolized by enzymes within human cells and do not typically pose an acid-base risk by reducing pH to a threatening degree in healthy individuals.
However, the specific dehydrogenase that converts D-lactate to pyruvate is far less active than that for L-lactate, and it has been suggested that very young infants may be a vulnerable group for D-lactic acidosis. Previous data have shown that urinary D-/L- lactate excretion were not significantly different between 2 groups of 4 month old infants taking a control formula or a formula containing D-lactate producing probiotics for 4 weeks. However, measures were not collected in babies during the first month after birth.
In this study we want to test the safety of D-lactate producing bacteria in babies from birth to 1 month of age. This safety study is a randomized, controlled, single center, clinical trial of 2 groups of infants.
The primary objective of this clinical trial is:
to evaluate the effect of a starter formula containing D-lactate producing probiotics versus a starter formula without probiotics, on D-lactic acid urine levels in healthy formula-fed infants, from birth to 28 days of age. Urinary D-lactate concentration (mmol/mol creatinine), will be measured at (baseline, 7 days, 14 days and 28 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy babies, full term (≥37 weeks gestation) who are 0-24 hours of age at enrolment.
- •Babies anticipated to be exclusively formula-fed.
- •Babies under the care of a paediatrician or other qualified healthcare professional and have had at least one postnatal visit.
- •Study explained and written information provided to Parent/Caregiver demonstrating understanding of the given information.
- •Informed consent signed (parent/legal representative)
排除标准
- •Babies with chromosomal or major congenital anomalies.
- •Significant pre natal and/or post natal disease
- •Babies receiving an antibiotic
- •Babies born from mothers using supplemental probiotics during the last trimester of pregnancy and/or antibiotics during the last 14 days of pregnancy.
- •Babies' family, of whom in the investigator's assessment, cannot be expected to comply with the protocol.
- •Babies currently participating in another clinical study
结局指标
主要结局
D-lactic acid urine measure in babies
时间窗: 1 month
次要结局
- anthropometric measures (Weight, length, and head circumference, stool microbiota, adverse events(6 months)