Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

April 7, 2015 updated by: Institut Hospitalo-Universitaire Méditerranée Infection
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children from Niamey and Dakar, Senegal

Description

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. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Senegal
Stool samples on Children with and without severe acute malnutrition in Senegal recruited in 3 locations (Dakar, Dielmo and Ndiop)
Biological: Stool samples
Stool samples
Niger
Stool samples Children with and without severe acute malnutrition in Niger recruited in Niamey
Biological: Stool samples
Stool samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerotolerant Odds ratio (AOR)
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Hospitalo-Universitaire Méditerranée Infection

Investigators

  • Study Chair: Matthieu Million, Assistance Publique des Hôpitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAMGUT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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