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Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants
Sponsor: University of Virginia
Summary
We are examining the role of circulating T follicular helper (Tfh) cells in the induction of the antibody responses. We 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 our 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. We will monitor the children for one year to measure T follicular helper function, antibody production, and reinfection.
Key Details
Gender
All
Age Range
6 Months - 48 Months
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-06-01
Completion Date
2028-06-01
Last Updated
2026-05-29
Healthy Volunteers
No
Conditions
Interventions
Azithromycin
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.
Locations (1)
Icddr,B
Dhaka, Bangladesh