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Clinical Trials/NCT07615842
NCT07615842Not yet recruitingPhase 1

Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants

University of Virginia1 site in 1 country150 target enrollmentStarted: June 1, 2026Last updated:

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Enrollment
150
Locations
1

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
6 Months to 48 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • presenting with diarrheal symptoms
  • age under 1 year
  • enrolled in study NCT02764918

Exclusion Criteria

  • unwilling to give blood and stool samples

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

William Petri, MD, PhD

Principle Investigator

University of Virginia

Study Sites (1)

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