Skip to content

Effect of a bioactive solution on the duration of diarrhoea in adults

Assessment of the capability of a novel bioactive polyphenol solution on the duration of diarrhoea in adults: a randomised placebo-controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10890482
Enrollment
150
Registered
2015-01-21
Start date
2012-01-15
Completion date
Unknown
Last updated
2015-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhoea in adults Digestive System Diarrhoea

Interventions

Patients will be randomly allocated to oral rehydration solution (ORS) and bioactive polyphenol solution or ORS and water on day 1 and then monitored for 5 days to determine the time for resolution of

Sponsors

LiveLeaf Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18–80 years 2. Provided informed consent 3. Acute diarrhoea (for 48 hours or less)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Resolution of diarrhoea, assessed as the time that stool had a Bristol Stool Scale ranking of 4 or less

Secondary

MeasureTime frame
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

Countries

Nicaragua

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026