Efficacy and Safety of Polystrain Probiotics for Chronic Abdominal Pain in children aged 7-14 years: A Prospective, Open-labelled, Randomised, Parallel Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- 1. Changes in pain in study population
研究概览
简要总结
Chronic abdominal pain is a common disorder affecting school-
going children and often results in significantly low attendance rates and high school
absenteeism. Since the pathophysiology of CAP is poorly understood and there is limited
data regarding the efficacy and safety of the few therapeutic options available, management
of CAP in children can be challenging. Probiotics have shown potential as microbiota
modulators in various Gastro Intestinal Disorders. However, there is limited research
available evaluating the efficacy and safety of probiotics in managing CAP in children.
Therefore, this study is undertaken to investigate the effect of polystrain probiotics in
children suffering from chronic abdominal pain.
The eligible patients will be randomly allocated to 2 treatment groups: Group A and Group
B (n=66 in each group)
• Group A will be given Polystrain Probiotics twice a day as an add-on to standard of care
for 2 weeks.
• Group B will be given standard of care for 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 7.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic Abdominal Pain diagnosed according to ROME 4 Criteria.
- •Legally Authorized Representative/Participants willing to give assent/consent for the study.
排除标准
- •Organic pain warning signs (includes age under 5, right upper and right lower abdominal pain, failure to thrive).
- •Having organic disease (urinary tract infection, celiac disease, parasites, etc.) and other chronic diseases.
- •Patient on Antibiotics, Prokinetics.
- •Acute Infection.
- •Undergone abdominal surgery within 1 month.
结局指标
主要结局
1. Changes in pain in study population
时间窗: 2nd week and 4th week
ï‚Ÿ Severity/Intensity
时间窗: 2nd week and 4th week
ï‚Ÿ Frequency
时间窗: 2nd week and 4th week
ï‚Ÿ Duration
时间窗: 2nd week and 4th week
2. Change in Quality of Life (QoL) in study population
时间窗: 2nd week and 4th week
次要结局
- 1. Number of patients requiring escape treatment(2. Adherence to treatment)
研究者
Dr Savita Verma
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak