A Randomized, Controlled, Double-blind, Cross-over, Single-centre Study to Investigate the Effect of a Fermented Infant Formula on Lactose Digestion in Lactose Intolerant Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Log of First Postprandial Peak Change of Hydrogen Concentration
研究概览
简要总结
The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5 and 24.9 kg/m2 inclusive Lactose intolerant
- •The following criteria need to be checked at visit 2:
- •Lactose intolerance confirmed by positive Hydrogen Breath Test (HBT) (i.e. if there are two or more samples with hydrogen level > 20 ppm increase compared to baseline sample between 90 mins and 240 min sampling time point).
- •At least one sample with hydrogen level > 20 ppm increase compared to baseline between 90 mins and 180 mins sampling time point.
排除标准
- •History of gastrointestinal disorders Current illness which could interfere with the study (e.g. diarrhea, regurgitation) Any history of cow's milk protein allergy or known allergy to galacto-oligosaccharides Any current participation or within 8 weeks of study start, in any other study involving investigational or marketed products, any medical procedures, or any surgical methods.
- •Any antibiotic, laxative or colonic cleansing treatments within 4 weeks of study start Any administration of probiotic in the 1 week prior to study start Investigator's uncertainty about willingness or ability of subject to comply with protocol requirements
- •The following criteria need to be checked at visit 2:
- •Level of hydrogen > 20 ppm in the baseline breath sample.
- •An early peak of hydrogen (i.e. hydrogen level > 20 ppm increase compared to baseline value) in the first 60 minutes after ingestion of the study products.
研究组 & 干预措施
Group I
Fermented infant milk formula
干预措施: Fermented infant milk formula (Other)
Group II
Non-fermented infant milk formula
干预措施: Non-fermented infant milk formula (Other)
结局指标
主要结局
Log of First Postprandial Peak Change of Hydrogen Concentration
时间窗: Postprandial peak hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4
This is measured as the log of the first change \>20ppm peak value compared to baseline between 90 minutes and 240 minutes. If there was no change \>20ppm at all between 90 minutes and 240 minutes, it is the maximum change compared to baseline in that interval
Log of Maximum Postprandial Change in Hydrogen Concentration
时间窗: Maximum postprandial hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4
This is measured as the maximum change in postprandial hydrogen concentration (ppm) compared to baseline between 90 minutes and 240 minutes
次要结局
- Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes(Hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 30, 60, 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4)