Condition category
Digestive System
Date applied
09/01/2015
Date assigned
21/01/2015
Last edited
21/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
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

20110201

Study information

Scientific title

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

Acronym

Study hypothesis

Consumption of a bioactive polyphenol solution will reduce the time to resolution of diarrhoea by 20%

Ethics approval

Institutional review board of the Universidad Centroamericana de Ciencias Empresariales, Managua, Nicaragua, 15/10/2011, 201113

Study design

Interventional randomised placebo-controlled trial at a single community health clinic

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Diarrhoea in adults

Intervention

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.

Intervention type

Supplement

Phase

Drug names

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

08/08/2011

Overall trial end date

15/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

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

15/01/2012

Recruitment end date

10/05/2012

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

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

Sponsor type

Industry

Website

http://liveleaf.com

Funders

Funder type

Industry

Funder name

LiveLeaf Inc

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan is to publish in a peer-reviewed journal indexed by PubMed.

Intention to publish date

30/03/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes