EUCTR2012-002291-13-DE进行中（未招募）不适用
Multicentre, prospective, double-blind, two-armed, placebo-controlled phase III study to evaluate the efficacy and safety of the treatment of diarrhoea with Lactobacillus rhamnosus GG (InfectoDiarrstop LGG Mono Beutel) in infants and toddlers - Diarrhoea therapy with Lactobacillus rhamnosus GG
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed consent to trial participation in writing encompassing consent to data recording and verification procedures, is to be given by both parents (or legal representatives, if applicable) of the patient before the first administration of trial medication
- •Male or female infants or toddlers aged 28 days to 24 months
- •Clinical diagnosis of diarrhoea (> 3 watery and/or loose stools during the past 24 hours)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diarrhoea for more than 3 days (72 hours)
- •Diarrhoea after stay abroad
- •Bloody stools
- •Dehydration > 5% (loss in weight)
- •Systemic treatment with antibiotics (currently or during the past 24 hours)
- •Malnutrition (according to clinician’s assessment)
- •Severe or chronic disease of the gastrointestinal tract
- •Short bowel syndrome
- •Phenylketonuria
- •Clinically relevant primary or secondary immunodeficiency
- •Malignant tumour, chemotherapy, or radiotherapy (currently or during the past 6 months)
- •Other severe diseases that the investigator assesses as conflicting with the participation
- •Premature infants (gestational age < 38 weeks)
- •Lactose intolerance
- •Hypersensitivity to the active pharmaceutical ingredient or any other ingredient of the trial medication
- •Intake of highly dosed probiotics (> one billion of colony forming units (CFU)/day during the past 7 days before inclusion)
- •Other antidiarrhoeal medical therapies (currently or during the past 7 days)
- •Inability of the parents to understand the instructions of the trial
- •Obvious unreliability of the parents or missing willingness to cooperate
- •Known addiction of the parents to alcohol, medicaments, or drugs
- •Dependency of the child or the parents on the sponsor or on an investigator
- •Participation in a clinical trial during the past 30 days
- •Participation of a sibling in the present clinical trial
- •Previous participation in the present clinical trial
研究者
相似试验
进行中（未招募）
不适用
International trial involving numerous sites in several countries to investigate the efficacy in shortening diarrhoea and safety for small children (infants and toddlers) by treatment with Lactobacillus rhamnosus GG (brand name: InfectoDiarrstop LGG Mono)EUCTR2012-002291-13-PLInfectoPharm - Arzneimittel und Consilium GmbH150
进行中（未招募）
1 期
Multicenter, prospective, double-blind, two-armed phase III study for efficacy and safety of the topic impetigo therapy of two 2 % mupirocin ointmentsImpetigoEUCTR2011-002001-30-DEINFECTOPHARM Arzneimittel und Consilium GmbH120
已完成
4 期
to study the effect and safety of two products in treatment of psoriasis.CTRI/2012/09/003001Glenmark Pharmaceuticals Limited200
进行中（未招募）
1 期
Study to evaluate in children under 18 years of age the efficacy and safety of a local anesthetic used in flat foot interventions or inguinal hernia at two different concentrations (1% and 2%) administered to two separate groups of patients.Pediatric patients undergoing surgery of flatfoot or inguinal herniaMedDRA version: 20.0Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 100000004865EUCTR2018-000656-18-ESSINTETICA SA174
进行中（未招募）
1 期
Study to evaluate in children under 18 years of age the efficacy and safety of a local anesthetic used in flat foot interventions or inguinal hernia at two different concentrations (1% and 2%) administered to two separate groups of patients.EUCTR2018-000656-18-ITSINTETICA SA174