CTRI/2024/12/078094招募中Phase 3 4
A Randomized, Double-Blind, Placebo-controlled study to evaluate the efficacy of probiotic CECT 7347 in infantile colic symptom relief
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 10
- 主要终点
- To evaluate the effect of 28 days of supplementation with a probiotic product on infant crying and fussing time in infants with colic as assessed by diary records
研究概览
简要总结
The present study is a randomized, double-blind, placebo-controlled study. Approximately 143 infants will be screened, and considering a screening failure rate of 20%, at least 114 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have not less than 40 evaluable participants after accounting for a dropout/withdrawal rate of 30%. The intervention duration for all the study participants is 28 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Day(s) 至 3.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Gestational age of minimum 37+0 weeks.
- •Birth weight of minimum 2500 g.
- •Age greater than 3 weeks and less than equal to 10 weeks.
- •Confirmed infantile colic defined as: a.
- •Parental report of crying and/or fussing for more than equal to 3 hours per day for more than equal to 3 days per week
- •Participant informed consent form signed by parent or legal guardian.
- •Parents or legal guardians are willing to comply with the study procedures, and the carer of the infant can attend all 3 study visits.
排除标准
- •Use of antibiotics by the infant within 2 weeks prior to screening.
- •Use of probiotic supplements from birth to enrolment (including probiotic-containing formula)
- •Use of dairy products by the infants (e.g., cow milk, goat milk, etc)
- •Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
- •Congenital disorders that, in the investigator’s opinion, would impact gastrointestinal tract
- •Evidence of infant failure to thrive, it indicates by the infant falling below the 75th percentile in weight-for-length percentile and head circumference-for-age percentiles according to WHO growth standards.
- •Known lactose or gluten intolerance
- •Known allergy to cow’s milk protein or any substances in the product or placebo
- •Known other cause of abdominal pain (i.e. pyloric stenosis)
- •Participation in any other clinical study within 90 days prior to the screening.
- •Immune-compromised participant or participant with other severe chronic disorder
- •Use of probiotic supplements by breastfeeding mother from child’s birth to enrolment
- •Use of antibiotics by breastfeeding mother within 2 weeks’ prior to screening.
- •Any parent/legal guardian who is an employee of the sponsor/study site.
结局指标
主要结局
To evaluate the effect of 28 days of supplementation with a probiotic product on infant crying and fussing time in infants with colic as assessed by diary records
时间窗: Screening, Randomization, Virtual Follow-up I, | End of Intervention & Virtual Follow-up II
次要结局
- To evaluate the effect of 28 days’ supplementation with probiotic product on:(-Resolution of colic symptoms as assessed by diary records)
- Exploratory Objectives(To evaluate the effect of 28 days of supplementation with probiotic product on:)
研究者
Dr Sanjay Vaze
Vedic Lifesciences Pvt. Ltd.
研究点 (10)
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