Bifidobacterium Adolescentis PRL2019 in Pediatric Irritable Bowel Siyndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Rome IV criteria
研究概览
简要总结
Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder (FGID) characterized by recurrent episodes of defecation related abdominal pain associated with abnormal bowel habit. Several studies have reported significant alterations in the gut microbiota that may promote the development and persistence of IBS. Some Bifidobacterium species, mainly Bifidobacterium adolescentis, have a documented immunomodulatory effect and can modulate visceral hypersensitivity or improve the integrity of the intestinal epithelium barrier thorough its well-known ability to produce g-aminobutyric acid
Thus, designed a randomised, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of Bifidobacterium adolescentis PRL2019 on abdominal pain symptoms in pediatric patients with Irritative bowel sindorom
详细描述
This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to evaluate the efficacy and safety of Bifidobacterium adolescentis PRL2019 in pediatric patients (> 4 years) with Irritative bpwel sindrome (as assessed according to the Rome IV diagnostic criteria for IBS).
The study will include a 2-week screening period, and a 12-week placebo-controlled treatment period. After the screening phase, eligible patients will be randomly assigned to either 1 stick containing 20 Mld UFC of Bifidobacterium adolescentis PRL2019 (Gabapral, Pontenure, Italy), or the equivalent placebo (without the active treatment, once a day, in a 1:1 ratio, for 12 weeks. Study visits will be conducted every 4 weeks during the treatment period. All the subjects will be blindly allocated by means of scratch cards to one of the two treatment groups according to a computer-generated randomisation list provided by our statistician. A validated program will be used by an independent statistician to generate a randomisation list with blocks, block size = 4, pre-allocated to centres. Patients and study investigators will be blinded to the randomisation codes. The codes will be kept confidential until the end of the study when the randomisation code will be broken after the database lock.
All subjects will undergo a formal clinical assessment and will be further phenotyped using validated questionnaires. Number of bowel movements per day and/or week and bowel habit characteristics, will be assessed by the Bristol stool scale.
The protocol will be approved by an independent ethics committee and conducted according to the Declaration of Helsinki and the principles of good clinical practice. The trial will be registered in a public registry.
The primary outcome will be the change in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period. Secondary outcomes will be modifications of bowel habits and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •the current use of nonsteroidal anti-inflammatory drugs, corticosteroids and mast cell stabilisers,
- •the use of topical or systemic antibiotics in the last month,
- •use of stimulant laxatives,
- •major abdominal surgery,
- •inflammatory bowel disease,
- •infectious diarrhoea,
- •allergic diseases a
- •psychiatric disorders.
研究组 & 干预措施
Placebo
Children with irritative bowel sindrome who received placebo once a day for 12 weeks
干预措施: Placebo (Drug)
GABAPRAL
Children with irritative bowel sindrome who received 20 Mld UFC of Bifidobacterium adolescentis PRL 2019 once a day for 12 weeks
干预措施: Gabapral (Drug)
结局指标
主要结局
Rome IV criteria
时间窗: 2 months
The primary outcome will be the improve in the abdominal pain symptoms (frequency and severity) according to validated score from baseline to the end of the treatment period.
次要结局
- bristol stool scale(6 months)
研究者
Dr. Enrico Felici
Doctor
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria