Open Label Study to Assess the Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Time (in Hours) Between the 1st Intake of IQP-MM-101 and First Formed or Hard Stool (Type 6 to 1) Followed by a Non Watery Stool (Type 6 to 1)
研究概览
简要总结
Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several studies demonstrating their efficacy, the investigators are conducting this study to look into the efficacy and safety of IQP-MM-101 in diarrhoea control.
详细描述
The clinical study was intended to evaluate the safety and the potential reduction of diarrhoea recovery time post 1st intake of IQP-MM-101 in an open label, single arm, multicentre study over a 72 hours period. There were 2 clinic visits: the screening visit and final visit.
At baseline visit (visit 1), written informed consents were collected. Each patients were given a diary and the following data were collected: demographics, vital signs, physical examination results, use of concomitant medication, previous medical history, and case history of the acute diarrhoea episode including date of first watery stool, number of stools over the past 24 hours, and presence of other associated symptoms over the past 24 hours (nausea, vomiting, abdominal pain).
Subjects recorded the following data in the diary: date and hour of bowel movement, stool consistency (Bristol stool scale) presence of symptoms such as nausea, vomiting, abdominal pain and study IP consumption (number, date, and time of tablets taken) and time of vomiting (if any) each day during the treatment period. Additionally, subjects recorded the time absent from work and a subjective evaluation of their "energy for everyday life".
Visit 2 took place after 72 hours treatment period. Following data was collected:
- Vital signs, physical examination
- Adverse events
- Use of concomitant medication
- Compliance (returned IP and diary)
- Global evaluation of efficacy and safety by subjects and investigators
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65 years
- •Good general health
- •Acute diarrhoea episode defined as at least three watery stools per 24 hours over a period of 48 hours or less
- •Acute diarrhoea of presumed infectious origin
- •Patients with usually normal bowel movements (defecations) before onset of diarrhoea, that is, at least three normal stools per week and three or less normal stools per day
- •Negative pregnancy test (ß HCG-test) for women with child bearing potential
- •Written informed consent is a prerequisite for subject enrollment
排除标准
- •Known sensitivity to the ingredients of the device
- •Fever >38,5◦C
- •Blood or pus in stools
- •Dehydration requiring intravenous rehydration
- •History of chronic diarrhoea (three or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months)
- •Use of antidiarrhoeal agents over the month prior to baseline
- •Diarrhoea possibly induced by antibiotics, laxative agents, thyroid hormones, or colchicine
- •Irritable bowel syndrome
- •Any other acute or chronic disease that could interfere with the evaluation of study device
- •Females who are pregnant or lactating
- •Subjects who have participated in another clinical trial in the 30 days before treatment period
- •Inability to comply
- •Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
研究组 & 干预措施
IQP-MM-101
Dissolve the effervescent tablets in half a glass of water,to be taken orally
1 tablet, 3 times a day
干预措施: IQP-MM-101 (Device)
结局指标
主要结局
Time (in Hours) Between the 1st Intake of IQP-MM-101 and First Formed or Hard Stool (Type 6 to 1) Followed by a Non Watery Stool (Type 6 to 1)
时间窗: 96 hours
In essence the definition of recovery would be two consecutive non-watery stool (type 6 to 1) when stool before 1st intake of IQP-MM-101 is primarily watery (type 7).
次要结局
- Time (Hours) From the First Intake to the Last Watery Stool(96 hours)
- Number of Daily Defecation(96 hours)
- Number of Watery Stools(96 hours)
- Stool Frequency(96 hours)
- Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)(72 hours)
- Abdominal Pain(96 hours)
- Time Off From Work(1 week)
- Evaluation of Subjects' Energy Level(96 hours)
- Global Evaluation of Safety and Efficacy by Subjects and Investigators(96 hours)
- Occurrence of Adverse Events (AEs)(96 hours)
- Associated Symptoms Such as Vomiting(96 hours)
- Stool Consistency(96 hours)
- Severity of Nausea(96 hours)