ISRCTN - ISRCTN57765025: Effect of a bioactive solution on the duration of diarrhoea in adult and paediatric patients

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
tlawson@liveleaf.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Lawson

ORCID ID

http://orcid.org/0000-0001-5182-4681

Contact details

1160 Industrial Road
Suite 11
San Carlos
94070
United States of America
+16505177288
tlawson@liveleaf.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20110101

Study information

Scientific title

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

Acronym

Study hypothesis

Consumption of a bioactive polyphenol solution will reduce the duration of acute diarrhoea by 20%

Ethics approval

Institutional review board of the Universidad Centroamericana de Ciencias Empresariales (Managua, Nicaragua), 10/05/2010, 201005

Study design

Randomised double-blind placebo-controlled crossover study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format. Please use the contact details below to request a patient information sheet.

Condition

Acute diarrhoea (for less than 48 hours)

Intervention

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

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

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

12/02/2010

Overall trial end date

07/12/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 5–80 years old
2. Diarrhoea for less than 48 hours

Participant type

Patient

Age group

All

Gender

Both

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
3. Fever
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

14/09/2010

Recruitment end date

07/12/2010

Locations

Countries of recruitment

Nicaragua

Trial participating centre

Community health clinic of Universidad Centroamericana de Ciencias Empresariales
Managua
Nicaragua

Sponsor information

Organisation

LiveLeaf Inc

Sponsor details