Phase 4
N=248
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
Child Development
Bottom Line
View on ClinicalTrials.gov: NCT03187834 ↗Enrolled (actual)
248
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome — 10.2; 8.8; 9.7; 9.6 Index score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azithromycin (Drug); Amoxicillin (Drug); Cotrimoxazole (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome |
10.2; 8.8; 9.7; 9.6; 8.3; 6.6 | — |
| SECONDARY Simpson's Index of Diversity (Alpha Diversity) in Microbiome |
— | — |
| SECONDARY Weight-for-height Z-score |
-0.24; -0.71; -0.27; -0.52; -0.17; -0.49 | — |
| SECONDARY Height-for-age Z-score |
-0.80; -0.92; -0.69; -0.73; -1.16; -1.38 | — |
| SECONDARY Weight-for-age Z-score |
-0.60; -1.01; -0.58; -0.78; -0.78; -1.12 | — |
| SECONDARY Mid-upper Arm Circumference |
15.01; 14.53; 15.49; 14.90; 15.15; 14.83 | — |
| SECONDARY Shannon's Index of Diversity (Alpha Diversity) in Intestinal Microbiome |
16.6; 14.6; 15.6; 15.4; 13.9; 11.0 | — |
| SECONDARY Shannon's Index of Diversity (Alpha Diversity) in Nasopharyngeal Microbiome |
— | — |
| SECONDARY L1-norm Distance on Bacterial Reads (Intestinal) |
16.6; 14.6; 15.6; 15.4; 13.9; 11.0 | — |
| SECONDARY L1-norm Distance on Bacterial Reads (Nasopharyngeal) |
— | — |
| SECONDARY L2-norm Distance on Bacterial Reads (Intestinal) |
10.2; 8.8; 9.7; 9.6; 8.3; 6.6 | — |
| SECONDARY L2-norm Distance on Bacterial Reads (Nasopharyngeal) |
— | — |
| SECONDARY Number of Participants With Macrolide Resistance Genes |
12; 9 | — |
| SECONDARY Alpha Diversity in the Intestinal Microbiome |
— | — |
Summary
The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome. This study is designed to estimate the effect of antibiotic consumption on microbiome in a rural region of rural Burkina Faso. Changes in the intestinal and nasopharyngeal microbiome and resistome following a short course of antibiotics will be measured.
Eligibility Criteria
Inclusion Criteria
- Households will be eligible for inclusion in the study if they have 2 or more children aged 6 months to 59 months currently residing in the household. Children from the household will be eligible if they are 6-59 months of age and are not currently receiving antibiotic treatment
Exclusion Criteria
- Children who are allergic to any of the study antibiotics will be excluded. Individuals aged under 6 months and 5 years or older will be excluded. Children already receiving antibiotics for an ongoing disease will be excluded.
Data sourced from ClinicalTrials.gov (NCT03187834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.