Plain English Summary
Background and study aims
Diarrhoea is a leading cause of death in children, and results in health decline and time lost at work for adults. Oral rehydration solution (ORS) is the standard of care for individuals with non-infectious diarrhoea. It reduces the dehydration caused by diarrhoea, but does not reduce the time to resolution of diarrhoea. The aim of the study is to test whether adding a novel polyphenol solution to ORS might reduce the time to resolution of the diarrhoea compared with the resolution time with ORS alone.
Who can participate?
Adults and children with diarrhoea for less than 48 hours
What does the study involve?
Participants will receive ORS plus the polyphenol solution or ORS plus water once at the start of 2 days and the resolution of diarrhoea and other intestinal symptoms will be recorded.
What are the possible benefits and risks of participating?
The benefits are the reduction of the duration of diarrhoea with no side-effects. The risk is that a patient might have an adverse event to the polyphenol solution.
Where is the study run from?
Community clinic associated with the Universidad Centroamericana de Ciencias Empresariales (Nicaragua)
When is the study starting and how long is it expected to run for?
From February 2010 to December 2010.
Who is funding the study?
LiveLeaf Inc (USA).
Who is the main contact?
Dr Thomas Lawson
Assessment of a bioactive polyphenol solution on the duration of acute diarrhoea in adult and paediatric patients: a randomised double-blind placebo-controlled crossover study
Consumption of a bioactive polyphenol solution will reduce the duration of acute diarrhoea by 20%
Institutional review board of the Universidad Centroamericana de Ciencias Empresariales (Managua, Nicaragua), 10/05/2010, 201005
Randomised double-blind placebo-controlled crossover study
Primary study design
Secondary study design
Randomised cross over trial
Patient information sheet
Not available in web format. Please use the contact details below to request a patient information sheet.
Acute diarrhoea (for less than 48 hours)
1. Oral rehydration solution and bioactive solution on day 1 and then oral rehydration solution and water (placebo) on day 2
2. Oral rehydration solution and water (placebo) on day 1 and then oral rehydration solution and bioactive polyphenol solution on day 2
Primary outcome measures
Resolution to diarrhoea, assessed as the time from ingestion of the solution to when an individual produced a stool with a Bristol Stool Scale ranking of 4 or less.
Secondary outcome measures
1. Defecation urgency, ranked from 0 (none) to 10 (extreme) at the various time intervals by patients (adults) and caregivers (for children)
2. Bloating or gas, ranked from 0 (none) to 10 (extreme) at the various time intervals by patients (adults) and caregivers (for children)
3. Abdominal pain at 30, 60, 90 and 120 minutes after consumption of the solutions on day 1 and day 2; pain was ranked from 0 to 10 on the Visual Analogue Scale
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. 5–80 years old
2. Diarrhoea for less than 48 hours
Target number of participants
The target total recruitment of participants was 200 patients.
Participant exclusion criteria
1. History of uncontrolled emesis
2. Grossly bloody stool
4. Clinical signs of a coexisting acute systemic illness (e.g., meningitis, sepsis or pneumonia)
5. Underlying chronic disease (e.g., heart disease, cystic fibrosis or diabetes)
6. Food allergies or other chronic gastrointestinal diseases
7. Use of probiotic agents in the previous 3 weeks or antibiotics or anti-diarrhoeal medications including over-the-counter and herbal substances in the previous 2 weeks
8. Generalised cachexia
9. Any signs of internal bleeding or drug abuse
10. Any condition, assessed with a standard of care, to cause unnecessary risk if participant given oral rehydration solution alone
11. Unable or unwilling 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
Publish the results from the study in a peer-reviewed journal that is indexed in PubMed
Intention to publish date
Participant level data
Available on request
Results - basic reporting