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

ISRCTN ISRCTN10890482
DOI https://doi.org/10.1186/ISRCTN10890482
Secondary identifying numbers 20110201
Submission date
09/01/2015
Registration date
21/01/2015
Last edited
21/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Thomas Lawson
Scientific

1160 Industrial Road
Suite 11
San Carlos
94070
United States of America

ORCiD logoORCID ID 0000-0001-5182-4681
Phone +16505177288
Email tlawson@liveleaf.com

Study information

Study designInterventional randomised placebo-controlled trial at a single community health clinic
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleAssessment of the capability of a novel bioactive polyphenol solution on the duration of diarrhoea in adults: a randomised placebo-controlled study
Study objectivesConsumption of a bioactive polyphenol solution will reduce the time to resolution of diarrhoea by 20%
Ethics approval(s)Institutional review board of the Universidad Centroamericana de Ciencias Empresariales, Managua, Nicaragua, 15/10/2011, 201113
Health condition(s) or problem(s) studiedDiarrhoea in adults
InterventionPatients 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 typeSupplement
Primary outcome measureResolution of diarrhoea, assessed as the time that stool had a Bristol Stool Scale ranking of 4 or less
Secondary outcome measuresChange 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 study start date08/08/2011
Completion date15/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsThe target total recruitment of participants was 150 patients.
Key inclusion criteria1. Age 18–80 years
2. Provided informed consent
3. Acute diarrhoea (for 48 hours or less)
Key exclusion criteria1. 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
Date of first enrolment15/01/2012
Date of final enrolment10/05/2012

Locations

Countries of recruitment

  • Nicaragua

Study participating centre

Community health clinic of Universidad Centroamericana de Ciencias Empresariales
Managua
Nicaragua

Sponsor information

LiveLeaf Inc
Industry

1160 Industrial Road
Suite 11
San Carlos
94070
United States of America

Phone +16505177288
Email tlawson@liveleaf.com
Website http://liveleaf.com
ROR logo "ROR" https://ror.org/00m48tn76

Funders

Funder type

Industry

LiveLeaf Inc

No information available

Results and Publications

Intention to publish date30/03/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlan is to publish in a peer-reviewed journal indexed by PubMed.
IPD sharing plan