跳至主要内容
临床试验/NCT03952988
NCT03952988Unknown不适用

Effect of the Consumption of a Probiotic (B. Bifidum 900791)-Containing Ice-cream in Adult With Hypolactasia and Lactose Intolerance

University of Chile0 个研究点目标入组 50 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Area under curve (AUC) of hydrogen in the HBT

研究概览

简要总结

Lactase is high in the newborn intestine, allowing him to digest the high amounts of lactose present in breastmilk. From weaning, lactase is genetically programmed to decrease, reaching residual levels in the adult. This situation occurs in 75% of the world population and is known as "adult primary hypolactasia" while the remaining 25% is "lactase persistent" i.e. maintains in adulthood lactase values similar to these of newborns. In subjects with hypolactasia, the intake of milk products can produce digestive symptoms, making that the affected individuals spontaneously reduce the consumption of these products and, therefore, their intake of calcium and proteins.

In addition to lactose-free milk and exogenous lactase, a strategy for the intolerant subjects to continue consuming dairy products is, for example, to consume yogurt, due to the fact that the lactase of the yogurt bacteria continues to function in the intestine of the consumer, hydrolyzing lactose and decreasing the development of digestive symptoms. Similarly, many probiotic strains, such as L. acidophilus NCFM, L. casei CRL431, B. longum 401 and B. bifidum Orla Jensen 1424, express β-galactosidases that hydrolyze lactose, preventing its fermentation and the production of gases. The acute administration of these strains improves lactose tolerance. In addition, a recent study reported that dietary supplementation of intolerant subjects for 4 weeks with L. casei Shirota and B. breve Yakult reduced digestive symptoms and breath hydrogen excretion not only at the end of the period of administration of the probiotics but also 3 months after having discontinued the use of probiotics.

Based on this background, the aim of this study is to determine whether the regular consumption of an ice cream with the strain B. bifidum 900791 improves lactose intolerance in hypolactasic subjects, even after the suspension of the consumption of the product. To determine if this effect is due to the adaptation of the microbiota, the investigators will also evaluate changes in the composition of the microbiota and the generation of volatile fatty acids.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of hypolactasia and lactose intolerance

排除标准

  • Previous gastrointestinal pathologies
  • Current or recent intake of antibiotics, anti-inflammatory drugs, laxatives or drugs interfering with intestinal transit
  • Alterations of intestinal anatomy or function
  • Pregnancy
  • Chronic diseases of different etiologies (auto-immune, inflammatory, tumor, etc.).

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Placebo ice cream (Dietary Supplement)

Probiotic

Experimental

干预措施: Probiotic ice cream (Dietary Supplement)

结局指标

主要结局

Area under curve (AUC) of hydrogen in the HBT

时间窗: Day 15

Acute effect of the probiotic on hydrogen excretion after lactose ingestion

次要结局

  • Area under curve (AUC) of hydrogen in the HBT(Day 71)
  • Fecal microbiota alpha-diversity(Day 71)
  • Relative abundancies of the bacterial taxa forming the the fecal microbiota(Day 71)
  • Fecal counts of B. bifidum 900791(Days 71)
  • Fecal beta-galactosidase activity(Days 71)
  • Fecal short chain fatty acids concentrations(Days 71)
  • Scores of gastrointestinal symptoms: bloating, abdominal distention, abdominal pain, borborygms and flatulence, during the HBT(Days 71)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Gotteland

Head, Lab. of Digestive physiology

University of Chile

相似试验