NCT02732743已完成不适用
An Open Label, Non-comparative Pilot Study to Assess the Efficacy and Safety of the Food Supplement Physiomanna® Baby in Pediatric Patients With a History of Functional Constipation
Iuppa Industriale Srl1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of Spontaneous Bowel Movements (SBM) per week
研究概览
简要总结
The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation
The secondary objective of the trial is to evaluate the adherence to product's administration in the enrolled children.
详细描述
This is an interventional, non-controlled, multicenter trial with a prospective design in one cohort of patients. This clinical investigation will be performed in 3 centers in Romania.
The tested hypothesis is that Physiomanna® Baby administration for 3 weeks, increases the SBM to be more than 2 times per week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 1 Week 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients between the ages of 0 to 8 years;
- •Functional constipation according to ROME III criteria (Annex 2);
- •Two or fewer SBM during the previous week; SBM is defined as BM not preceded after a 24 h administration with a laxative or enema;
- •To be otherwise in good health, as judged by a physical examination;
- •Mentally competent parent or tutor to sign an informed consent
排除标准
- •Known history of organic cause for the constipation;
- •Congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases);
- •Fecal Occult Blood Test (FOBT) positive in the 4 previous weeks;
- •Fecal impaction at baseline, or during the trial period, as indicated by the physical examination;
- •Known or suspected perforation or obstruction other than fecal impaction;
- •History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy;
- •Use of concomitant medications that cause constipation in the previous 3 months;
- •Concomitant use of herbs and other dietary supplements, such as: stimulant laxative herbs and/or potassium depleting herbs;
- •Concomitant use of cardiac glycosides(e.g. Digoxin);
- •Patients who, according to the investigator, should not be included in the study for any reason, including the parent's inability to follow the study procedures;
- •Patients with known allergy to Fraxinus Manna, mannitole, fennel, lemon balm or chamomile;
- •Patients with clinically significant elevations of TSH or abnormal plasma electrolytes in the 4 previous weeks;
- •Patients who, within the past 30 days have participated in an investigational clinical study;
研究组 & 干预措施
Food Supplement Physiomanna® Baby
Other
Dosage: 1g/kg body
干预措施: Physiomanna® Baby (Dietary Supplement)
结局指标
主要结局
Number of Spontaneous Bowel Movements (SBM) per week
时间窗: 2-3 weeks
次要结局
- Safety: Adverse Events (AE) check; Investigator and Patient Global Assessment(2-3 weeks)
研究者
研究点 (1)
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