Randomized, Blinded, Placebo-controlled, Study of Clinical and Laboratory Effects of L. Reuteri NCIMB 30351 in Functional Disorders of Gastrointestinal Tract and Skin Symptoms of Food Allergy in Children During the First Months of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in the number of infantile colics
研究概览
简要总结
This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive.
The aim of the study is to assess clinical effects of probiotics Lactobacillus Reuteri NCIMB 30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life, laboratory parameters of microbiome will also be assessed.
A prospective study comparing two treatment groups:
Group 1 (treatment group) - 60 infants. Group 2 (control group) - 30 infants, placebo. The study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fennel)), etc.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Month 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents / guardians speak Russian, understand the essence of study, are informed about the purpose of the study, understand their rights and signed informed consent form (ICF).
- •Vaginal delivery.
- •Full-term newborn.
- •Age at the time of the signing of informed consent form 1-4 months 28 days.
- •Breast- and formula-fed infants.
- •Colic , constipation , diarrhea, regurgitation (single symptom or combination of several symptoms).
- •Infant does not have other deviations in health, which would require the appointment of a specialized diet
- •Parents / guardians can and ready to regularly fill out the proposed diary form.
排除标准
- •Born by Cesarean section.
- •Premature newborn.
- •Congenital abnormalities or other clinical manifestations that may interfere with the study.
- •Lactase food supplements.
- •Other probiotic drugs, antibiotics, enteric antiseptics, antifungal and antiprotozoal drugs.
结局指标
主要结局
Change in the number of infantile colics
时间窗: 25 days from the start of treatment
Infantile colics are defined according to IV Rome criteria
次要结局
- Presence of skin symptoms of food allergy(25 days from the start of treatment)
- Change in concentrations of stool carbohydrates(25 days from the start of treatment)
- Change in the number of diarrhea cases(25 days from the start of treatment)
- Change in the number of gastroesophageal reflux (posseting) cases(25 days from the start of treatment)
- Change in the number of constipations(25 days from the start of treatment)
- Change in concentrations in stool filtrate of volatile fatty acids(25 days from the start of treatment)
- Change in 16S RNA sequencing(25 days from the start of treatment)