A Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Dietary Supplement BioAmicus Complete (Oral Drops; a Mixture of 10 Strains of Lacto- and Bifidobacteria) in Managing Functional Gastrointestinal Disorders and Cutaneous Symptoms of Food Allergy in Infants During the First Months of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Gastroesophageal reflux
研究概览
简要总结
This is a randomized, single-blind, placebo-controlled study to evaluate the efficacy of the dietary supplement BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria) in managing functional gastrointestinal disorders and cutaneous symptoms of food allergy in infants during the first months of life.
The aim of the study is to assess clinical effects of BioAmicus Complete drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life.
A prospective study comparing two treatment groups:
Group 1 (treatment group) - 70 infants. Group 2 (control group) - 70 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 (fenhel)), 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
- •The child's parents/guardians speak Russian, have been informed about the study's purpose, understand its essence, are aware of their rights, and have signed the informed consent form.
- •Diarrhea or constipation accompanied by colic and/or regurgitation (gastroesophageal reflux, GER).
- •Cutaneous manifestations of food allergy.
- •The child was born at term or preterm, but not before the 7th month of gestation.
- •Age at the time of parental informed consent: from 1 month to 4 months and 28 days.
- •The child is on breastfeeding, formula feeding, or mixed feeding.
- •The child has no other health conditions that would require a specialized diet.
- •The parents/guardians are able and willing to regularly complete the proposed observation diary form.
排除标准
- •The child has a congenital pathology or any other conditions/diseases/clinical manifestations that may interfere with participation in the study.
- •Use of lactase supplements.
- •Use of other probiotic products, antibiotics, enteral antiseptics, antifungal, or antiprotozoal medications.
- •The child was born preterm (before the 7th month of gestation).
研究组 & 干预措施
Placebo
Sunflower oil
干预措施: Placebo (Dietary Supplement)
Bioamicus Complete
BioAmicus Complete drops
干预措施: BioAmicus Complete (Dietary Supplement)
结局指标
主要结局
Gastroesophageal reflux
时间窗: 29 days
GER, assessed by changes in the number of GER episodes per day
Constipation or diarrhea
时间窗: 29 days
assessed by changes in stool frequency \[number of bowel movements\] and perceived ease of defecation. Episodes per day.
Frequency and duration of colic
时间窗: 29 days
assessed by changes in the number of colic episodes, number of crying episodes, and average duration of crying. Episodes per day and duration in minutes.
次要结局
- Cutaneous manifestations of food allergy.(29 days)
- Weight increase(29 days)