β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion: Probiotic and Lactose Intolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT)
研究概览
简要总结
The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion.
详细描述
The trial will be cross over, randomized in incomplete blocks, controlled, double-blind:
each subject will be administered 3 products out of 4 (positive control, probiotic Streptococcus (S.) thermophilus, probiotic Bifidobacterium (B.) longum, negative control) in a random order on 3 different days separated by a washout period of at least one week, and maximum 2 weeks between each challenge.
The total sample size is 42 enrolled subjects/37 completed Patients will be males and females aged between 20 and 65 years with positive hydrogen breath test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HBT> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests
- •Having signed the informed consent or having provide his/her legal representative's informed consent
排除标准
- •Known Food allergy
- •Any obstructive (COPD, asthma...) or restrictive respiratory syndrome that may impact breath test measurements
- •Any medically relevant malabsorption syndrome
- •Any medically relevant chronic gut motility disorder other than Irritable Bowel Syndrome (IBS), assessed with Rome III questionnaire
- •Ongoing therapy with drugs known to affect gut motility
- •Any general antibiotherapy taken during or within 4 weeks of study onset
- •Use of lactase pill (eg. Lacdigest®), as well as yoghurt and probiotics, for at least 2 days prior to Visit 0b
- •Subject who cannot be expected to comply with the study procedures
- •Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.
- •To be a close collaborator to the Investigators, either in terms of Family relationship and/or professional relationship
- •Pregnancy, based on anamnesis
结局指标
主要结局
Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT)
时间窗: HBT measured every hour during 4 hours after challenge (HBT curve)
次要结局
- Assessment of improvement of lactose intolerance symptoms using a composite score equal to the sum of individual symptoms measured using a visual analog scale (VAS)(4 hours after every milk intake, from the time of ingestion up to 5 hours)