About this trial
The investigators are examining the role of circulating T follicular helper (Tfh) cells in the induction of the antibody responses. The investigators hypothesize that Tfh cell activation is impaired in Bangladeshi children and that this activation failure is associated with a history of antibiotic use. The results of the investigators' preliminary studies suggest that antibiotic treatment could have a detrimental effect on the development of an appropriate adaptive immune response against Cryptosporidium. Antibiotic treatment for children with cryptosporidiosis, rotavirus and adenovirus 40/41is not currently recommended (supportive therapy only), although usually given to children in Dhaka, Bangladesh. This study will randomly assign children with diarrhea due to Cryptosporidium, rotavirus or adenovirus 40/41 to two groups. Supportive treatment would be provided in both groups, but in group #1, antibiotic treatment would be withheld while group #2 will receive usual care which normally will include antibiotic treatment. The investigators will monitor the children for one year to measure T follicular helper function, antibody production, and reinfection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
presenting with diarrheal symptoms
age under 1 year
enrolled in study NCT02764918
Disqualifiers
unwilling to give blood and stool samples
Trial design
Parallel
Treatments tested in this trial
Azithromycin
DrugAntibiotic treatment (azithroymicin) for children with cryptosporidiosis is not currently recommended (supportive therapy only). The proposed modification to this study would involve randomly assigning the Cryptosporidium-positive children to two groups. Supportive treatment would be provided in both groups, but in one group, antibiotic treatment would be withheld. All children would continue to be monitored in accordance with standard protocols, and antibiotic treatment would be provided if deemed clinically necessary.
Treatment groups
Trial outcomes
Primary outcomes
T follicular helper activation
Secondary outcomes
Antibodies to pathogens
Antibodies to cryptosporidium, rotavirus and/or adenovirus 40/41
Reinfection
Reinfection with cryptosporidium, rotavirus and/or adenovirus 40/41
Measures of Malnutrition
Weight, height
Sponsors and contacts
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University of Virginia
Lead sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborator
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