NCT02413905

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

1.2 years

First QC Date

March 30, 2015

Last Update Submit

April 7, 2015

Conditions

Severe MalnutritionMalnutritionInfant Nutrition DisordersChild Nutrition DisordersKwashiorkorMarasmus

Outcome Measures

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)

    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)

Study Arms (2)

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

Stool samplesBIOLOGICAL

Stool samples

NigerSenegal

Eligibility Criteria

AgeUp to 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children from Niamey and Dakar, Senegal

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital National

Niamey, Niger

Location

Clinic Notre Dame de L'Esperance, Thiaroye

Dakar, Senegal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

MalnutritionInfant Nutrition DisordersChild Nutrition DisordersKwashiorkorProtein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSevere Acute MalnutritionProtein DeficiencyDeficiency Diseases

Study Officials

  • Matthieu Million

    Assistance publique des Hôpitaux de Marseille

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 10, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

NI(1)SE(1)