A Prospective, Quasi Randomized Double Blind Placebo Controlled Study of L.Reuteri on Infantile Colic
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- •Treatment success, defined as the percentage of children achieving a reduction in the daily average crying time to less than 3 hrs., and the duration of crying (minutes per day) at 7,14, 21 and 28 days after randomization with reference to baseline (recorded daily by parent as well)
研究概览
简要总结
This study is to evaluate the effect of probiotic (Lactobacillus reuteri UBL Ru-87) in the treatment of infantile colic and to assess the recovery of gut microbiota dysbiosis with probiotic use. Considering the inclusion and exclusion criteria, all infants who had a diagnosis of infantile colic according to Rome III criteria: episodes of crying lasting more than 3 h a day, for 3 or more days in 1 week prior to eligibility assessment will be enrolled to the randomized double-blind, placebo-controlled study. Efficacy of the formulation will be tested for treating infantile colic.The percentage of children achieving a reduction in the daily average crying time to less than 3 hrs., and the duration of crying (minutes per day) at 7,14, 21 and 28 days after randomization with reference to baseline (recorded daily by parent as well) will be considered as treatment success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 4.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Age: from birth to <4 months of age 2.Diagnosed with infantile colic (defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment) according to Rome III criteria and recommended with nutritional supplementation of Lactobacillus reuteri for infantile colic by the treating physician 3.Full term infant, i.e., gestational age between 37 and 42 weeks 4.Breast fed, either exclusively 5.Birth weight ≥ 2500g 6.Apgar score more than 8 at 5 minutes at birth 7.Written informed consent from parents to share data as per protocol and adhere to routine follow up visits as required by treating physician 8.Parent(s) willing to maintain same infant feeding mode throughout study period 9.Parent(s) willingness and ability to fill in diary and questionnaires.
排除标准
- •1.Significant co-existing illness or major medical problem, which in opinion of treating physician does not make patient suitable for participation in study 2.Any other gastrointestinal disorder 3.Failure to thrive 4.Use of antibiotics two weeks before enrollment and throughout the intervention period, for both infant and mother 5.Use of probiotics two weeks before enrollment and throughout the intervention period, for both infant (infant formula and/or supplementation) and mother 6.Use of acid suppressive therapy two weeks before enrolment and throughout the intervention period.
- •7.Infant receiving solid foods, such as cereals, mashed fruits or vegetable puree 8.Participation in any other interventional study.
结局指标
主要结局
•Treatment success, defined as the percentage of children achieving a reduction in the daily average crying time to less than 3 hrs., and the duration of crying (minutes per day) at 7,14, 21 and 28 days after randomization with reference to baseline (recorded daily by parent as well)
时间窗: Visit 1 Screening and baseline assessment. | Treatment Initiation (day 0) | Visit 2 Follow-up 1 (Day 07 ± 2 days) | Visit 3 Follow-up 2 (Day 14 ± 2 days) | Visit 4 Follow-up 3 (Day 21 ± 2 days) | Visit 5 End of study (Day 28 ± 2 days)
次要结局
- a.The percentage of children achieving a reduction in the daily average crying time defined as the percentage of children achieving a reduction in the daily average crying time ≥50% (Timeline on day 28 with reference to baseline)(b.Persistence of infantile colic after the intervention (Timeline on day 28 with reference to baseline))