Condition category
Signs and Symptoms
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://cmcvellore.ac.in

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

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

Results - basic reporting

Publication summary

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18270575

Publication citations

  1. 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.

Additional files

Editorial Notes