The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 10
- 主要终点
- Symptoms of infantile colic
研究概览
简要总结
The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.
详细描述
Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.
The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or female.
- •Age ≤ 8 weeks old.
- •Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days.
- •Exclusively breastfeeding and planning to breastfeed for duration of study.
- •With a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent.
- •With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and telephone calls.
排除标准
- •Birthweight < 2500 g.
- •Gestational age < 37 weeks.
- •Apgar score at 5 minutes <
- •Partially or fully formula fed infants, with the exception of the first 4 days after birth.
- •Stunted growth/weight loss (< 100 g/week from birth to last reported).
- •Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations.
- •Fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
- •Genetic diseases and chromosomal abnormalities.
- •Metabolic diseases or pancreatic insufficiency.
- •Immunodeficiency.
- •Neurological diseases.
- •Suspected or confirmed food allergies and intolerances.
- •Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening.
- •Use of anti-colic medication at any time from birth to the moment of screening.
- •Use of probiotic supplements by the mother between the birth of their infant and the moment of screening.
- •Currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.
结局指标
主要结局
Symptoms of infantile colic
时间窗: 5 weeks
Comparison of the difference in the proportion of infants with reductions in mean daily crying duration by over 50 percent from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
次要结局
- Symptoms of infantile colic: Parental perception(5 weeks)
- Change in the mother's quality of life(5 weeks)
- Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time(5 weeks)
- Fecal strain recovery of the probiotic(5 weeks)
- Bowel movement frequency(5 weeks)
- Fecal microbiome composition(5 weeks)
- Symptoms of infantile colic: Daily crying duration(5 weeks)
- Symptoms of infantile colic: Number of crying episodes(5 weeks)
- Symptoms of infantile colic: Sleep duration(5 weeks)