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NCT Number: NCT03187834

Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso

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.

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Key information

Conditions

Child Development Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Corneal Diseases Eye Diseases Eye Infections Eye Infections, Bacterial Gram-Negative Bacterial Infections Infections Trachoma

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso

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About this study

This study is designed to better understand the effect of a short course of antibiotics on changes in intestinal and nasopharyngeal microbiome on treated children and untreated household contacts. The investigators hypothesize that a short course of antibiotics will lead to decreased bacterial diversity shortly after completion of the antibiotic course, and higher probability of identification of bacterial resistance genes in rectal and nasopharyngeal samples. The investigators hypothesize that a 5-day course of antibiotics (azithromycin, amoxicillin, or co-trimoxazole) will lead to significantly decreased intestinal and nasopharyngeal bacterial diversity among children aged 6-59 months.

Specific Aim 1. Determine the effect of treatment with antibiotics on microbiome diversity in children aged 6-59 months following a 5-day course of antibiotics.

Specific Aim 1A. Determine the direct effect of a 5-day course of azithromycin, amoxicillin, or co-trimoxazole on intestinal and nasopharyngeal bacterial diversity in children aged 6-59 months compared to no treatment.

Specific Aim 1B. Determine the indirect effect of antibiotic treatment of children in a household on intestinal and nasopharyngeal bacterial diversity in an untreated child aged 6-59 months.

Specific Aim 1C. Assess the association between intestinal bacterial diversity and anthropometry in a population-based sample of children.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Azithromycin

Drug

Children in this arm will receive Azithromycin once a day.

Other names: Zithromax

Amoxicillin

Drug

Children in this arm will receive Amoxicillin twice a day.

cotrimoxazole

Drug

Children in this arm will receive co-trimoxazole once a day.

Placebo

Drug

Children in this arm will receive Placebo once a day.

Primary outcomes

  1. Simpson's Index of Diversity (Alpha Diversity) in Intestinal Microbiome

    Time frame: Baseline and Day 9

    The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.

Secondary outcomes

  1. Simpson's Index of Diversity (Alpha Diversity) in Microbiome

    Time frame: Day 9

    Direct and indirect effect of antibiotics on alpha diversity from rectal samples

  2. Weight-for-height Z-score

    Time frame: Day 35

    Nutritional status as determined by weight-for-height Z-score vs. Placebo household Weight-for-height Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-height Z (WHZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately wasted (WHZ). A cutoff of < -3 means wasted (WHZ).

  3. Height-for-age Z-score

    Time frame: Day 35

    Nutritional status as determined by height-for-age Z-score Height-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Height-for-age Z (HAZ) score were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately stunted (HAZ). A cutoff of < -3 means severely stunted (HAZ).

  4. Weight-for-age Z-score

    Time frame: Day 35

    Nutritional status as determined by weight-for-age Z-score vs. Placebo household Weight-for-age Z-score in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Weight-for-age Z-score (WAZ) scores were calculated based on the 2006 World Health Organization (WHO) standards. The mean of the 2006 population standards is 0. Lower standard deviations = worse outcomes. A cutoff of < -2 means moderately underweight (WAZ). A cutoff of < -3 means severely underweight (WAZ).

  5. Mid-upper Arm Circumference

    Time frame: Day 35

    Nutritional status as determined by mid-upper arm circumference in each antibiotic group compared with placebo 4 weeks after last antibiotic dose Mid-upper arm circumference (MUAC) in each antibiotic group compared with placebo 4 weeks after last antibiotic dose.

    MUAC is a measure to assess nutritional status. It is measured on a straight left arm, mid-way between the tip of the shoulder and the tip of the elbow. It identifies acute malnutrition and is commonly used in children 6-59 months of age as well as pregnant women. MUAC less than 115 mm indicates severe wasting or severe acute malnutrition (SAM). MUAC greater than or equal to 115 mm and less than 125 mm indicates moderate wasting or moderate acute malnutrition (MAM).

  6. Shannon's Index of Diversity (Alpha Diversity) in Intestinal Microbiome

    Time frame: Baseline and Day 9 (Post- Treatment)

    Shannon's Alpha Diversity at Baseline and Post-treatment. combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances.

  7. Shannon's Index of Diversity (Alpha Diversity) in Nasopharyngeal Microbiome

    Time frame: Day 9

    Direct and indirect effects of antibiotics on Shannon's index of bacterial diversity

  8. L1-norm Distance on Bacterial Reads (Intestinal)

    Time frame: Baseline and Day 9 (Post- Treatment)

    L1-norm distance on bacterial reads (intestinal) - L1 norm is equivalent to Shannon's diversity. Shannon's Alpha Diversity combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances.

  9. L1-norm Distance on Bacterial Reads (Nasopharyngeal)

    Time frame: Day 9

    L1-norm distance on bacterial reads (nasopharyngeal)

  10. L2-norm Distance on Bacterial Reads (Intestinal)

    Time frame: Baseline and Day 9 (Post- Treatment)

    L2-norm distance on bacterial reads (intestinal) - L2 norm is equivalent to Simpson's diversity. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.

  11. L2-norm Distance on Bacterial Reads (Nasopharyngeal)

    Time frame: Day 9

    L2-norm distance on bacterial reads (nasopharyngeal)

  12. Number of Participants With Macrolide Resistance Genes

    Time frame: 2 years

    Prevalence of macrolide resistance genes measured using DNA-seq from rectal swabs.

  13. Alpha Diversity in the Intestinal Microbiome

    Time frame: 2 years

    Alpha diversity in the intestinal microbiome using DNA-seq from rectal swabs

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Centre de Recherche en Sante de Nouna, Burkina Faso
  • Heidelberg University

Registry information

Acronym: ARMCA

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Jun 15, 2017
Registry last updated
Mar 2, 2023

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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