Multicenter, Randomized, Double-blind Parallel Group Pilot Study to Evaluate the Effect of Consuming a Combination of Probiotic Strains and a Combination of Plant Extracts and a Probiotic Strain on the Production and Nutritional Composition of Breast Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Volume of breast milk
研究概览
简要总结
The objective of this trial is to evaluate the effect of the consumption of a combination of probiotic strains (Prob-milk) and of a combination of plant extracts plus an inactivated probiotic strain (VoluntasProb) on the production volume and the nutritional composition and the microbiota. of breast milk in lactating women.
详细描述
Previous studies have shown the galactogogue effect of fenugreek, fennel, and milk thistle. However, to date no study has considered the evaluation of all three extracts. Additionally, certain probiotic strains of Lactobacillus and Bifidobacterium also appear to increase milk production in animal studies.
The objective of this trial is to evaluate the effect of the consumption of a combination of probiotic strains (Prob-milk) and of a combination of plant extracts plus an inactivated probiotic strain (VoluntasProb) on the production volume and the nutritional composition and the microbiota. of breast milk in lactating women. This is a preliminary study whose purpose is to gather information for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Lactating women between 18 and 45 years old, who have given birth to a healthy baby at term (born between 37 and 42 weeks).
- •Who have the perception of having little volume of milk or a nutritional composition of milk that is not adequate for their baby
- •That they are between week 2 and week 6 of breastfeeding, and that at the time of beginning the study they are not supplementing with formula milk the feeding of their baby.
- •That they have the firm intention of breastfeeding for 28 more days.
- •Women who agree to participate and have read, understood and signed the informed consent
排除标准
- •Suffering from any disease that may hinder or prevent breastfeeding
- •Being currently consuming or having consumed in the two weeks prior to the study a probiotic or a supplement with plant extracts.
- •Being consuming any drug that can alter the volume or composition of breast milk.
- •Have an allergy to any antibiotics or peanuts
- •Have an allergy to any of the components of the products under study
结局指标
主要结局
Volume of breast milk
时间窗: 28 days
The volume of breast milk production will be measured as the difference in weight in grams of the child before and after the first and last feeding of the day, measured on two consecutive days. It should be collected on the first two days before starting treatment and two days in a row separated by one week during treatment.
Microbiota of breast milk
时间窗: 28 days
Load of Lactobacillus, Bifidobacterium, Staphylococcus, Streptococcus in breast milk
次要结局
- Baby's anthropometric measures_height(28 days)
- Baby feces microbiota(28 days)
- Data about the intestinal health of the baby_color of the faeces(28 days)
- Measurement of IL-8 in breast milk(28 days)
- Measurement of IgA in breast milk(28 days)
- Baby's anthropometric measures_weight(28 days)
- Infantile colick symptoms(28 days)
- Nutritional composition of breast milk(28 days)
- Data about the intestinal health of the baby_stool frequency(28 days)
- Baby's anthropometric measures_BMI(28 days)
- Data about the intestinal health of the baby_consistency of the feces(28 days)
- Data about sleep parameters of the baby(28 days)