Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

Malnutrition Clinical Trial

Official title:

Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413905
• Other study ID #: SAMGUT
• Status: Completed
• Phase: N/A
• First received: March 30, 2015
• Last updated: April 7, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Institut Hospitalo-Universitaire Méditerranée Infection
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ethics Committee
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 59 Months

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Biological:
• Stool samples
Stool samples

Locations

Country	Name	City	State
Niger	Hopital National	Niamey
Senegal	Clinic Notre Dame de L'Esperance, Thiaroye	Dakar

Sponsors (1)

Lead Sponsor	Collaborator
Institut Hospitalo-Universitaire Méditerranée Infection

Countries where clinical trial is conducted

Niger,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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)	No