Icddr,B
Dhaka, Bangladesh
NCT Number: NCT07615842
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.
Trial opening soon.
Get Notified6 month–48 month
All sexes
Interventional
Phase 1
Dhaka, Bangladesh
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Antibiotic 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.
Time frame: 1 year
Time frame: 1 year
Antibodies to cryptosporidium, rotavirus and/or adenovirus 40/41
Time frame: 1 year
Reinfection with cryptosporidium, rotavirus and/or adenovirus 40/41
Time frame: 1 year
Weight, height
Contact information is provided by the study sponsor or research team.
University of Virginia
Other
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