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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 April 2015 |
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Main ID: |
NCT02413905 |
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Date of registration:
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30/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition
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Scientific title:
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Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02413905 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Niger
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Senegal
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Contacts
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Name:
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Matthieu Million |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance publique des Hôpitaux de Marseille |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
59 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Child Nutrition Disorders
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Severe Malnutrition
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Infant Nutrition Disorders
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Kwashiorkor
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Malnutrition
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Marasmus
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Intervention(s)
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Biological: Stool samples
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Primary Outcome(s)
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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)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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