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Trial registered on ANZCTR


Registration number
ACTRN12611000912987
Ethics application status
Approved
Date submitted
23/08/2011
Date registered
25/08/2011
Date last updated
25/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Esterified starch and oral rehydration solution as a treatment for acute infectious diarrhoea
Scientific title
A randomized controlled clinical trial in adults and children with acute infectious diarrhoea comparing the effects of high amylose maize starch acetate with high amylose maize starch as adjunct to oral rehydration solution on diarrhoea duration and stool output
Secondary ID [1] 262908 0
CTRI - Pending
Universal Trial Number (UTN)
U1111-1113-6538
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute infectious diarrhoea 270635 0
Condition category
Condition code
Oral and Gastrointestinal 270806 270806 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 270816 270816 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High amylose maize starch acetate, 10 g mixed per 200 ml oral rehydration solution (ORS), and consumed every hour and after every loose stool until stool consistency becomes formed or for a total of 72 hours.
Intervention code [1] 269258 0
Treatment: Other
Comparator / control treatment
High amylose maize starch, 10 g mixed per 200 ml ORS and consumed every hour and after every loose stool until stool consistency becomes formed or for a total of 72 hours.
Control group
Active

Outcomes
Primary outcome [1] 279501 0
Duration of diarrhoea defined as time from commencing therapy to first formed stool or 12 hour period without stool. Stool form is assessed by a technician according to the Bristol stool form scale, and formed stool is defined as type IV stool in the scale.
Timepoint [1] 279501 0
Continuous variable, time from 0-72 hours
Primary outcome [2] 279502 0
Stool weight in first 24 hours and total diarrhoea stool weight. Stool is collected in lined plastic containers and weighed every twelve hours on an electronic scale by a technician.
Timepoint [2] 279502 0
Measured every 12 hours till recovery or 72 hours
Secondary outcome [1] 287762 0
Need for unscheduled (i.e. after initial four hour rehydration period) intravenous fluids. Intravenous fluids are commenced if dehydration persists or worsens at the end of the first six hours of therapy, or dehydration reappears any time during subsequent course despite adequate intake of ORS.
Timepoint [1] 287762 0
Every 12 hour period till recovery or 72 hours.
Secondary outcome [2] 287763 0
Proportion of patients who recover from diarrhoea at 24 hours and at 48 hours. Recovery is defined as the passage of two consecutive formed stools (type IV on the Bristol stool form scale).
Timepoint [2] 287763 0
24 hours and 48 hours
Secondary outcome [3] 287764 0
Adverse events - serum sodium <120 mmol/L, serum creatinine >4 mg/dL, persistent vomiting
Timepoint [3] 287764 0
24 hours

Eligibility
Key inclusion criteria
Acute watery diarrhoea of less than three days’ duration and presence of dehydration.
Minimum age
12 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bloody diarrhoea
Concomitant illness including malignancy, sepsis, and a history of coronary artery disease or stroke.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive patients presenting to the Emergency services with acute dehydrating diarrhoea will be evaluated by the medical officer and offered inclusion in the study if suitable. The agents used for treatment in intervention and comparator arms are packed in sealed opaque envelopes which are sequentially numbered based on the randomization code. Neither the treating team nor the assessment team nor the patient is aware of the specific treatment received by each patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization, sequence generated by a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3808 0
India
State/province [1] 3808 0
Tamil Nadu

Funding & Sponsors
Funding source category [1] 269727 0
Government body
Name [1] 269727 0
Indo-Australian Biotechnology Fund
Address [1] 269727 0
Department of Biotechnology
Block II, 7th Floor, CGO Complex
Lodi Road, New Delhi 110003
Country [1] 269727 0
India
Primary sponsor type
University
Name
Christian Medical College
Address
Offoce of the Principal
Christian Medical College
Bagayam
Thorapadi Post Office
Vellore 632002
Country
India
Secondary sponsor category [1] 268767 0
Government body
Name [1] 268767 0
Department of Biotechnology
Address [1] 268767 0
Department of Biotechnology
Block II, 7th Floor, CGO Complex
Lodi Road, New Delhi 110003
Country [1] 268767 0
India
Other collaborator category [1] 252223 0
Individual
Name [1] 252223 0
Julie Clarke
Address [1] 252223 0
Commonwealth Scientific & Industrial Research Organisation
Kintore Avenue
Adelaide, SA 5000
Country [1] 252223 0
Australia
Other collaborator category [2] 252224 0
Individual
Name [2] 252224 0
Graeme Young
Address [2] 252224 0
Flinders Medical Centre
Room 3D230
Bedford Park, SA 5042
Country [2] 252224 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271695 0
Institutional Review Board
Ethics committee address [1] 271695 0
Christian Medical College
Office of the Principal
Bagayam
Thorapadi Post Office
Vellore 632002
Ethics committee country [1] 271695 0
India
Date submitted for ethics approval [1] 271695 0
Approval date [1] 271695 0
20/01/2010
Ethics approval number [1] 271695 0
IRB-A9-20-01-2010

Summary
Brief summary
The hypothesis behind the study is that high amylose maize starch acetate, a functional food that delivers acetate and other short chain fatty acids to the colon, will significantly shorten duration of diarrhoea and reduce diarrhoea stool output in patients with acute gastroenteritis. Short chain fatty acids are normally found in the lumen of the colon in high concentrations, being formed there by fermentation of carbohydrate. Reduction of colonic short chain fatty acids in diarrhoea is likely to prolong diarrhoea and slow recovery. High amylose maize starch, naturally found in several corn serovars, reduces diarrhoea in adults and children with gastroenteritis. We hypothesize that high amylose maize starch acetate, that delivers acetate to the colon besides undergoing fermentation to short chain fatty acids, will shorten diarrhoea to a greater extent than high amylose maize starch. In this double-blind randomized controlled clinical trial, adults with diarrhoea and dehydration will receive standard treatment including oral rehydration solution and early feeding, and in addition will receive either high amylose maize starch acetate or high amylose maize starch. Severely dehydrated patients will first receive intravenous fluids for rehydration followed by randomization. Duration of diarrhoea, diarrhoeal stool weight, need for unscheduled intravenous fluids will all be recorded.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33068 0
Address 33068 0
Country 33068 0
Phone 33068 0
Fax 33068 0
Email 33068 0
Contact person for public queries
Name 16315 0
B.S. Ramakrishna
Address 16315 0
Department of Gastroenterology
Christian Medical College
Ida Scudder Road
Vellore 632004
Country 16315 0
India
Phone 16315 0
+91 416 2282052
Fax 16315 0
+91 416 2282486
Email 16315 0
rama@cmcvellore.ac.in
Contact person for scientific queries
Name 7243 0
B.S. Ramakrishna
Address 7243 0
Department of Gastroenterology
Christian Medical College
Ida Scudder Road
Vellore 632004
Country 7243 0
India
Phone 7243 0
+91 416 2282052
Fax 7243 0
+91 416 2282486
Email 7243 0
rama@cmcvellore.ac.in

No information has been provided regarding IPD availability
Summary results
No Results