Plain English Summary
Background and study aims
Diarrhoea rarely results in death in adults, but can affect a family’s resources through extra health care costs and loss of wages. The current treatment (oral rehydration solutions [ORS]) reduces dehydration in patients but does not reduce the time to resolution of the diarrhoea. The aim in this study is to find out whether a bioactive solution can reduce the time an individual has diarrhoea.
Who can participate?
Adults with acute, non-infectious diarrhoea for up to 48 hours
What does the study involve?
Participants will be randomly allocated to one of two groups: ORS and water (control group) or a bioactive solution added to the ORS (test group) on day 1. They will be monitored for 5 days to find out the time to resolution of the diarrhoea.
What are the possible benefits and risks of participating?
A possible benefit is a shorter time to resolution of the diarrhoea. A possible risk is a reaction to the bioactive solution.
Where is the study run from?
Community health clinic of Universidad Centroamericana de Ciencias Empresariales (Nicaragua)
When is the study starting and how long is it expected to run for?
From August 2011 to May 2012
Who is funding the study?
LiveLeaf Inc (USA)
Who is the main contact?
Dr Thomas Lawson
Assessment of the capability of a novel bioactive polyphenol solution on the duration of diarrhoea in adults: a randomised placebo-controlled study
Consumption of a bioactive polyphenol solution will reduce the time to resolution of diarrhoea by 20%
Institutional review board of the Universidad Centroamericana de Ciencias Empresariales, Managua, Nicaragua, 15/10/2011, 201113
Interventional randomised placebo-controlled trial at a single community health clinic
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Diarrhoea in adults
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 diarrhoea and any changes to gastrointestinal symptoms.
Primary outcome measures
Resolution of diarrhoea, assessed as the time that stool had a Bristol Stool Scale ranking of 4 or less
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Age 18–80 years
2. Provided informed consent
3. Acute diarrhoea (for 48 hours or less)
Target number of participants
The target total recruitment of participants was 150 patients.
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Community health clinic of Universidad Centroamericana de Ciencias Empresariales
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Plan is to publish in a peer-reviewed journal indexed by PubMed.
Intention to publish date
Participant level data
Available on request
Results - basic reporting