NCT00937274

Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution

Randomized, Double Blind Placebo-controlled Studies to Evaluate the Effect of an Orally-fed Escherichia Coli (E. Coli) Phage in the Management of ETEC and EPEC Induced Diarrhea in Children

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: Male
• Age: 6 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

This study hopes to demonstrate the potentials of a new form of therapy for childhood diarrhea, a major cause of morbidity and deaths in Bangladesh and other developing countries, and thus a priority for improving child health.

Detailed description

This randomized double-blind, placebo controlled trial (RCT) aims to evaluate the effect of oral administered E. coli phage in children aged 4-60 months of age with proven ETEC and EPEC diarrhea. Children will be screened to exclude V. cholerae infections by dark field microscopy, rotavirus by stool ELISA, and invasive diarrhoea clinically as well as by stool microscopy, to identify children with possible ETEC and EPEC diarrhoea. Enrolled children will be randomly assigned, in equal numbers, to receive either: (i) a new T4 phage cocktail or (ii) Russian anti-E. coli phage cocktail (Microgen) at the dose recommended by the manufacturer or (iii) only oral rehydration solution (placebo) for 5 days in addition to management of dehydration and continued feeding in accordance with WHO guidelines. Duration of diarrhea, daily and cumulative stool output, volume of oral rehydration solution intake, stool frequency, time to recovery and weight gain will be the main outcome measures. As the dose of phage we intend to use in this therapeutic trial is higher than the dose administered to young children in earlier safety trial, we plan to initially conduct a safety study with these three study products in 45 children with non cholera, non rotavirus and non invasive diarrhea, to randomize equally in the three intervention groups, as for the final study mentioned above. The outcome measures in this safety part will include assessment of laboratory parameters including renal and liver function tests, haematological indices, and microbiological efficacy of phage by measuring phage and E. coli titre in daily stool samples. If the higher dose is found safe, tolerable, and not associated with any significant adverse event, we will proceed to the clinical efficacy trial. We believe if T4 coli phage is assessed to be effective in the overall diarrhea management, this might lead to development of an affordable and sustainable adjunct to the currently available case management of E. coli diarrhea, benefiting millions of children worldwide.

Conditions

• Diarrhea

Interventions

Type	Name	Description
OTHER	T4 phage cocktail test	T4 phages 106 PFU/ ml up to 5 days
OTHER	Commercial T4 phage cocktail	Treatment as recommended by the manufacturer (Microgen phages)
OTHER	standard oral rehydration solution (ORS)	Standard hospital treatment with ORS

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-07-10
• Last updated: 2013-11-13

Locations

1 site across 1 country: Bangladesh