Contact information
Type
Scientific
Primary contact
Mr Balakrishnan S Ramakrishnan
ORCID ID
Contact details
Christian Medical College
Williams Research Building
Department of Gastrointestinal Science
Ida Scudder Road
Vellore
632004
India
+91 (0)416 2282052
rama@cmcvellore.ac.in
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
063150
Study information
Scientific 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
Acronym
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.
The overall trial end date was changed from 15/03/2006 to 31/01/2007.
Ethics approval
Not provided at time of registration
Study design
Randomised single-blinded controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diarrhoea
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Amylase resistant starch, low osmolarity Oral Rehydration Solution (ORS)
Primary outcome measure
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 measures
No secondary outcome measures
Overall trial start date
01/01/2005
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Mixed
Gender
Male
Target number of participants
To be added
Participant 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.
Recruitment start date
01/01/2005
Recruitment end date
31/12/2006
Locations
Countries of recruitment
India
Trial participating centre
Christian Medical College
Vellore
632004
India
Sponsor information
Organisation
Christian Medical College (India)
Sponsor details
c/o George M Chandy
Ida Scudder Road
Vellore
632004
India
+91 (0)416 2282052
directorate@cmcvellore.ac.in
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18270575
Publication citations
-
Results
Ramakrishna BS, Subramanian V, Mohan V, Sebastian BK, Young GP, Farthing MJ, Binder HJ, A randomized controlled trial of glucose versus amylase resistant starch hypo-osmolar oral rehydration solution for adult acute dehydrating diarrhea., PLoS ONE, 2008, 3, 2, e1587, doi: 10.1371/journal.pone.0001587.