Severe MalnutritionNCT02413905
Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition
An observational study of Severe Malnutrition and Malnutrition, run by Institut Hospitalo-Universitaire Méditerranée Infection at 2 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages Up to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Severe Malnutrition, Malnutrition, Infant Nutrition Disorders
- What is being tested?
- Stool samples
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2014to Mar 2015
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from Niamey and Dakar, Senegal
Who may be able to join
- Children aged 0-59 months of varying nutritional status from Niamey (Niger) and Dakar (Senegal).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
- Conditions
- Severe Malnutrition, Malnutrition, Infant Nutrition Disorders, Child Nutrition Disorders, Kwashiorkor, Marasmus
- Being tested
- Stool samples
- Medical subject headings
- Malnutrition, Infant Nutrition Disorders, Child Nutrition Disorders, Kwashiorkor, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplesBiological
Stool samples
| Study group | Role | What they receive |
|---|---|---|
| Senegal | Stool samples on Children with and without severe acute malnutrition in Senegal recruited in 3 locations (Dakar, Dielmo and Ndiop) Receives: Biological: Stool samples | |
| Niger | Stool samples Children with and without severe acute malnutrition in Niger recruited in Niamey Receives: Biological: Stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Hospitalo-Universitaire Méditerranée Infection
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Million, Study chair, Assistance publique des Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413905
- Sponsor's protocol ID
- SAMGUT
- Status last verified
- Apr 2015
- First submitted
- 30 Mar 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No