RecruitingPhase 2Phase 3ACTRN12611000912987

Esterified starch and oral rehydration solution as a treatment for acute infectious diarrhoea

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


Sponsor

Christian Medical College

Enrollment

100 participants

Start Date

Aug 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 12 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special type of starch (high amylose maize starch acetate) given alongside oral rehydration solution can shorten the duration and severity of acute infectious diarrhea. Diarrhea causes a loss of important short-chain fatty acids in the colon that help the gut recover. This special starch delivers those fatty acids directly to the colon to speed healing. You may be eligible if: - You are between 12 and 75 years old - You have had watery diarrhea for less than 3 days - You are dehydrated as a result of the diarrhea You may NOT be eligible if: - You have bloody diarrhea - You have cancer, widespread infection, or a known history of coronary artery disease or stroke Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 7

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.


Locations(1)

Tamil Nadu, India

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ACTRN12611000912987