Effect of a bioactive solution on the duration of diarrhoea in adults
Completed
- Conditions
- Diarrhoea in adultsDigestive SystemDiarrhoea
- Registration Number
- ISRCTN10890482
- Lead Sponsor
- iveLeaf Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1. Age 18–80 years
2. Provided informed consent
3. Acute diarrhoea (for 48 hours or less)
Exclusion Criteria
1. History of uncontrolled emesis
2. Signs of coexisting acute sytemic illness (e.g., sepsis or pneumonia)
3. Underlying chronic disease (e.g., heart disease or diabetes)
4. Food allergies or other chronic gastrointestinal diseases
5. Use of probiotic agents in previous 3 weeks
6. Use of antibiotics or anti-diarrhoeal medication in previous 2 weeks
7. Severely malnourished
8. Showed signs of internal bleeding or drug abuse
9. Any condition the physician believed would put the patient at risk if given only standard treatment for diarrhoea
10. Unwilling or unable to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resolution of diarrhoea, assessed as the time that stool had a Bristol Stool Scale ranking of 4 or less
- Secondary Outcome Measures
Name Time Method Change in ranking of abdominal pain and bloating between day 1 and day 5 and any adverse events, measured with the Visual Analogue Scale of 0 to 10