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NCT Number: NCT07615842

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

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.

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Key information

Age range

6 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unwilling to give blood and stool samples

Treatment and study plan

Azithromycin

Drug

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.

Primary outcomes

  1. T follicular helper activation

    Time frame: 1 year

Secondary outcomes

  1. Antibodies to pathogens

    Time frame: 1 year

    Antibodies to cryptosporidium, rotavirus and/or adenovirus 40/41

  2. Reinfection

    Time frame: 1 year

    Reinfection with cryptosporidium, rotavirus and/or adenovirus 40/41

  3. Measures of Malnutrition

    Time frame: 1 year

    Weight, height

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Young

CONTACT

[email protected]

4348061737

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 29, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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