NCT05554991终止不适用
Efficacy and Tolerability of a Composition Comprising of HMO in a Supplement Format on Colic Management: a Double-blind, Randomized, Placebo-controlled Trial
Société des Produits Nestlé (SPN)12 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2022年6月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 12
- 主要终点
- Difference in average infant daily crying and fussing duration
研究概览
简要总结
Efficacy and tolerability of a composition comprising of HMO in a supplement format on colic management: a double-blind, randomized, placebo-controlled trial
详细描述
This is a double-blinded, randomized, placebo-controlled trial. The purpose of this trial is to investigate the efficacy and tolerability of a composition comprising of HMO in a supplement format in the management of colicky infants aged 2-12 weeks.
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
- Double (Participant, Investigator)
盲法说明
Randomization will be carried out using iMedidata Randomization Trial Supply Management System with the dynamic allocation algorithm.
入排标准
- 年龄范围
- 2 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants 2 weeks - 12 weeks of age at enrolment
- •Infants diagnosed with colic according to Rome IV criteria: Diagnostic criteria for research purposes (infant must meet all Rome IV criteria):
- •An infant who is less than 5 months of age (in the current clinical trial, only infants 2 weeks to 8 weeks of age will be enrolled) when the symptoms start and stop
- •Recurrent and prolonged periods of infant crying, fussing, or irritability reported by caregivers that occur without obvious cause and cannot be prevented or resolved by caregivers
- •No evidence of infant failure to thrive, fever, or illness
- •Excessive crying/fussiness for 3 or more hours per day during 3 or more days in the past 7 days as reported by parents to the clinician
- •Total 24-hour crying plus fussing is 3 hours or more when measured by at least one prospectively kept 24-hour behavior diary. (The Structured Infant Crying and Fussing Diary will be dispensed at the screening visit (V0), completed for two 24-hour periods at H0 (days -3 to -1), and returned at V1 to be used as part of the diagnostic criteria for infantile colic.)
- •Term infants (≥ 37 weeks) generally healthy with normal birth weight (≥2.5kg) and singleton born
- •Predominantly formula fed* (formula fed ≥ 80% of the time) for at least 7 days before randomization and the choice of formula feeding has been made by the parents before the beginning of the trial.
- •Infants who have been on the same formula for the past 5 days
- •Signed informed consent obtained for infant's and parents'/Legally Acceptable Representative (LAR) participation in the study
- •Parent/LAR of infant agrees not to enroll infant in another interventional clinical research study while participating in this study
- •Parent of the infant/LAR is willing and able to fulfill the requirements of the study protocol
- •Parent of infant can be contacted throughout the study
- •Predominantly formula feeding defined in the study means that the infant's predominant source of nourishment is formula. Specifically, infants are fed with formula for at least 80% of total milk feeds per day.
排除标准
- •Presence of any congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes.
- •Clinical evidence of chronic illness or gastrointestinal disorders, major medical problems (e.g. ill, immunocompromised, major developmental or genetic abnormality).
- •Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations.
- •Received any special formula (e.g. lactose-free, hydrolyzed protein) within 5 days before randomization or switched formulas within 5 days before randomization.
- •Received any of the following products/medication within 5 days before randomization:
- •Antibiotics
- •Prokinetics
- •Proton pump inhibitors
- •Simethicone
- •L. reuteri probiotic
- •Formula containing Human milk Oligosaccharides
- •Other infant(s) <6months of age living in the same household.
- •Current participation in another interventional clinical trial.
结局指标
主要结局
Difference in average infant daily crying and fussing duration
时间窗: At the end of the intervention period (day 21)
Difference in average infant daily crying and fussing duration at the end of the intervention in the Intervention Group (IG) versus the Control Group (CG). The crying and fussing duration is measured using a structured infant crying and fussing diary.
次要结局
- Modulation of infant gut microbiota (communities of microbes, their taxonomy, strain composition, diversity, ecology, functionalities, and the metabolites produced)(V1 (day 0), V2 (day 7), and V4 (day 21))
- Difference in average infant daily crying duration(Change from baseline (V1) to intervention end (V4))
- Overall GI tolerance and individual GI symptoms(1-day retrospective GI diary at V1 (day 0) and prospective 3-Day GI symptom diary diaries at home (H2, H3 and H4) just prior to V2 (day 7), V3 (day 14) and V4 (day 21))
- Fecal metabolism(V1 (day 0), V2 (day 7), and V4 (day 21))
- Infant anthropometry head circumference(V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21))
- Infant daily crying and fussing duration assessed longitudinally(Longitudinal changes across specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21))
- Percentage of children achieving a reduction in daily crying and fussing(At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21))
- Difference in average infant daily fussing duration(Change from baseline (V1) to intervention end (V4))
- Difference in average infant daily crying and fussing duration in the IG(Change from baseline (V1) to intervention end (V4))
- Difference in average infant daily crying duration in the Intervention group(Change from baseline (V1) to intervention end (V4))
- Difference in average infant daily fussing duration in the Intervention group(Change from baseline (V1) to intervention end (V4))
- Incidence of infantile colic(At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21))
- Infant sleep(V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21))
- Parental and family quality of life(V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21))
- Fecal markers of inflammation calprotectin(V1 (day 0) and V4 (day 21))
- Infant crying/fussing per 24 hours(At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21))
- Infant Quality of life(V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21))
- Infant fecal gut microbiota(V1 (day 0), V2 (day 7), and V4 (day 21))
- Infant anthropometry length gain(V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21))
- Infant illness and infection and medication usage(V1 (day 0) until V4 (day 21))
- Parental perception of colic severity(At specific visits V1 (day 0), V2 (day 7), V3 (day 14) and V4 (day 21))
- Fecal markers of inflammation lipocalin(V1 (day 0) and V4 (day 21))
- Infant anthropometry weight(V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21))
- Infant anthropometry length(V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21))
- Infant anthropometry weight gain(V1 (day 0), V2 (day 7), V3 (day 14) (optional if V3 is a phone call) and V4 (day 21))
研究者
研究点 (12)
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