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CompletedNCT02413905Updated Apr 10, 2015

Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

An observational study in Severe Malnutrition, Malnutrition and Infant Nutrition Disorders, sponsored by Institut Hospitalo-Universitaire Méditerranée Infection. Completed at 2 sites in 2 countries. Open to participants aged Up to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-10.

Sponsored by Institut Hospitalo-Universitaire Méditerranée Infection · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
Up to 59 Months
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Severe Malnutrition
  • Malnutrition
  • Infant Nutrition Disorders
  • Child Nutrition Disorders
  • Kwashiorkor
  • Marasmus
03

Who can participate

Ages eligible
Up to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children from Niamey and Dakar, Senegal

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Absence of parent or patient consent, antibiotic administration \<2 months before stool collection and insufficient fecal amount. Exclusion criteria for controls included any form of malnutrition, presence of fever, acute respiratory infection (cough), acute or chronic diarrhea in the previous 4 weeks. Symptoms and complications of malnutrition (cough, fever, diarrhoea, vomiting) nor other form of malnutrition (moderate to severe stunting and underweight) were not a reason of exclusion for cases since they are considered as direct consequence and part of severe acute malnutrition.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Senegal

    Stool samples on Children with and without severe acute malnutrition in Senegal recruited in 3 locations (Dakar, Dielmo and Ndiop)

    Biological: Stool samples

  • Niger

    Stool samples Children with and without severe acute malnutrition in Niger recruited in Niamey

    Biological: Stool samples

Interventions

  • BiologicalStool samples

    Stool samples

05

What researchers measure

Primary outcomes

  1. Aerotolerant Odds ratio (AOR)

    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)

    Time frame: 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)

06

Study locations

2 sites
  • Hopital National
    Niamey, Niger
  • Clinic Notre Dame de L'Esperance, Thiaroye
    Dakar, Senegal
07

Registry details

Key details

Study ID
NCT02413905
Lead sponsor
Institut Hospitalo-Universitaire Méditerranée Infection
Responsible party
Sponsor
First posted
Apr 10, 2015
Start date
Jan 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Apr 10, 2015

Study contacts

Matthieu Million
study chair · Assistance publique des Hôpitaux de Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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