Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02413905

Enrollment

100

Registered

2015-04-10

Start date

2014-01-31

Completion date

2015-03-31

Last updated

2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Nutrition Disorders, Infant Nutrition Disorders, Kwashiorkor, Malnutrition, Marasmus, Severe Malnutrition

Brief summary

The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).

Detailed description

Fecal samples of cases (severe acute malnutrition (SAM) ascertained according to the WHO definition) and controls (asymptomatic healthy children ascertained by clinical and anthropometric criteria) were analysed by v3v4 16S rRNA sequencing, redox and pH measurement and using specific polymerase chain reaction targeting Methanobrevibacter smithii and Bacteroides thetaiotaomicron. Based on the literature and oxydative stress reported in SAM, the investigators tested if the proportion of aerotolerant prokaryotes is increased among gut prokaryotes enriched in SAM in comparison to prokaryotes enriched in controls. The investigators further linked this to fecal redox potential and assessed the total number of bacteria in feces by flux cytometry.

Interventions

BIOLOGICALStool samples

Stool samples

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 59 Months

Healthy volunteers

Yes

Inclusion criteria

* Children aged 0-59 months of varying nutritional status from Niamey (Niger) and Dakar (Senegal).

Exclusion criteria

* Absence of parent or patient consent, antibiotic administration \<2 months before stool collection and insufficient fecal amount.

Design outcomes

Primary

Measure	Time frame	Description
Aerotolerant Odds ratio (AOR)	1 day (Participants were not followed as this is a case-contol study only clinical and anthropometric data and fecal samples were collected the day of inclusion)	AOR = (number of aerotolerant prokaryotes enriched in the gut of children with SAM \* number of obligate anaerobic prokaryotes enriched in controls)/(number of aerotolerant prokaryotes enriched in controls \* number of obligate anaerobic prokaryotes enriched in children with SAM)

Countries

Niger, Senegal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026