ISRCTN10890482CompletedNot Applicable
Assessment of the capability of a novel bioactive polyphenol solution on the duration of diarrhoea in adults: a randomised placebo-controlled study
iveLeaf Inc0 sites150 target enrollmentStarted: January 21, 2015Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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