Diarrhoeal disease is the second-leading cause of under-five mortality in the world, as well as a major cause of both growth failure and delayed cognitive development in children. The objective of this study was to verify the feasibility of a randomized controlled trial (RCT) designed to measure the benefit of rapid enteric diagnostic testing and Lactobacillus reuteri therapy for children admitted to hospital in Botswana with acute gastroenteritis.
Children with acute diarrhoea aged 2-60 mos. admitted to hospital were eligible if they did not have bloody stools or signs of sepsis. Participants received standard fluid rehydration plus zinc and were randomized to one of:
1) rapid diagnostic testing (plus targeted antimicrobial therapy if indicated) plus Lactobacillus reuteri therapy x 60 days
2) rapid diagnostic testing (plus targeted antimicrobial therapy if indicated) plus placebo therapy x 60 days
3) standard care (no diagnostic testing) plus L. reuteri therapy x 60 days
4) standard care plus placebo therapy x 60 days.
Multiplex PCR assays were used to detect Shigella, Campylobacter, enterotoxigenic E. coli, and Cryptosporidium. For this pilot study, achievement of feasibility outcomes was primary; these included validation of trial protocols, ensuring that testing and treatment could be integrated into clinical care, and verifying recruitment rates. Clinical outcomes included height-for-age (HAZ) at 60 days adjusted for baseline HAZ and recurrence of diarrhoea in the 60-day followup period.
In a 6-month study period, 76 participants without severe acute malnutrition were enrolled, with a median age of 10.8 months. Compared to standard care plus placebo therapy, rapid diagnostics plus placebo therapy was associated with a 0.28 SD (95% CI -0.26,0.81) increase in 60-day adjusted HAZ and less recurrent diarrhoea in the followup period (OR 0.45, 95% CI 0.12,1.79). Rapid diagnostics plus L. reuteri therapy was associated with a significant 0.63 SD (95%CI 0.12- 1.13, p=0.02) increase in 60-day adjusted HAZ and significantly less recurrent diarrhoea (OR 0.07, 95%CI 0.01- 0.61, p=0.02).
Our results suggest that a multicentre trial is feasible. Rapid diagnostics and Lactobacillus reuteri therapy hold promise for the treatment of gastroenteritis and the prevention of stunting in children living in high- burden settings.
M. Mokomane, None
K. Lechiile, None
B. Moorad, None
M. Smieja, None
L. Mazhani, None
M. Loeb, None
K. Stordal, None
D. Goldfarb, None
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