|
ISRCTN
|
ISRCTN72841333
|
|
DOI
|
10.1186/ISRCTN72841333
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Comprehensive studies of a new improved oral rehydration solution for diarrhoeal disease: physiological and molecular studies, clinical trials, and acceptability and efficacy studies in a rural south Indian community
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
063150
|
|
Study hypothesis
|
The hypothesis is that addition of amylase resistant starch to a low osmolarity Oral Rehydration Solution (ORS) will reduce the duration and severity of diarrhoea in a variety of diarrhoeal diseases including cholera and non-cholera diarrhoea. The studies consist of two randomised trials in adults and children respectively comparing the newly recommended low osmolar ORS to low osmolar ORS with added amylase resistant starch. The objective is to determine whether subjects in the trial arm will have reduced stool output and duration of diarrhoea.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised, single blinded, controlled clinical trial
|
|
Countries of recruitment
|
India
|
|
Disease/condition/study domain
|
Diarrhoea
|
|
Participants - inclusion criteria
|
In the adult study, all adult male patients presenting to the Emergency Service with acute severe watery diarrhoea of less than three days' duration, with moderate to severe dehydration, will be enrolled after informed written consent.
In a separate trial, male children aged six months to five years with diarrhoea (defined as more than three watery stools/24 hours) of three days or less, with mild or moderate dehydration, or those with severe dehydration who have received intravenous rehydration, will be enrolled after informed written consent from the parent.
|
|
Participants - exclusion criteria
|
In the adult trial, subjects without clinical dehydration, those with presence of blood in stool, and presence of significant systemic illness unrelated to the diarrhoea, will be excluded.
In the children's trial, bloody diarrhoea, concurrent severe illness (such as pneumonia, meningitis or infections requiring antibiotics), and severe malnutrition Grade III and IV will be treated as exclusion criteria.
|
|
Anticipated start date
|
01/01/2005
|
|
Anticipated end date
|
31/01/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
To be added - recruitment ends in 31st December 2006
|
|
Interventions
|
Eligible subjects will be randomised to one of two treatment arms to receive either reduced osmolarity ORS or reduced osmolarity ORS along with amylase resistant starch. All other treatment measures will be identical in the two groups. ORS will be administered according to World Health Organisation (WHO) treatment guidelines for management of acute diarrhoea. Stool consistency and weight will be determined by personnel unaware of the treatment received by the patient.
The adult trial is closed to recruitment and follow up is complete. Therefore a new anticipated end date of 31st January 2007 has been provided. The previous end date of this trial was 15/03/2006.
The trial in children is continuing to recruit patients.
|
|
Primary outcome measure(s)
|
1. Stool weight in successive 12 hour periods
2. Stool weight in the second 24 hours
3. Time to last unformed stool
4. Requirement for unscheduled intravenous fluids
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
The Wellcome Trust (UK) (grant ref: 063150)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/18270575
|
|
Contact name
|
Mr
Balakrishnan S
Ramakrishnan
|
|
Address
|
Christian Medical College
Williams Research Building
Department of Gastrointestinal Science
Ida Scudder Road
|
|
City/town
|
Vellore
|
|
Zip/Postcode
|
632004
|
|
Country
|
India
|
|
Tel
|
+91 (0)416 2282052
|
|
Fax
|
+91 (0)416 2232035
|
|
Email
|
rama@cmcvellore.ac.in
|
|
Sponsor
|
Christian Medical College (India)
|
|
Address
|
c/o George M Chandy
Ida Scudder Road
|
|
City/town
|
Vellore
|
|
Zip/Postcode
|
632004
|
|
Country
|
India
|
|
Tel
|
+91 (0)416 2282052
|
|
Fax
|
+91 (0)416 2232035
|
|
Email
|
directorate@cmcvellore.ac.in
|
|
Sponsor website:
|
http://cmcvellore.ac.in
|
|
Date applied
|
22/07/2005
|
|
Last edited
|
22/03/2013
|
|
Date ISRCTN assigned
|
22/07/2005
|
