Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-27 @ 2:14 PM
Study NCT ID:
NCT02413905
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2015-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D007228', 'term': 'Infant Nutrition Disorders'}, {'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D007732', 'term': 'Kwashiorkor'}, {'id': 'D011502', 'term': 'Protein-Energy Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}, {'id': 'D011488', 'term': 'Protein Deficiency'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2015-04-07', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aerotolerant Odds ratio (AOR)', 'timeFrame': '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)', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Malnutrition', 'Malnutrition', 'Infant Nutrition Disorders', 'Child Nutrition Disorders', 'Kwashiorkor', 'Marasmus']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children from Niamey and Dakar, Senegal', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Children aged 0-59 months of varying nutritional status from Niamey (Niger) and Dakar (Senegal).\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT02413905', 'briefTitle': 'Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'Institut Hospitalo-Universitaire Méditerranée Infection'}, 'officialTitle': 'Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition', 'orgStudyIdInfo': {'id': 'SAMGUT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Senegal', 'description': 'Stool samples on Children with and without severe acute malnutrition in Senegal recruited in 3 locations (Dakar, Dielmo and Ndiop)', 'interventionNames': ['Biological: Stool samples']}, {'label': 'Niger', 'description': 'Stool samples Children with and without severe acute malnutrition in Niger recruited in Niamey', 'interventionNames': ['Biological: Stool samples']}], 'interventions': [{'name': 'Stool samples', 'type': 'BIOLOGICAL', 'description': 'Stool samples', 'armGroupLabels': ['Niger', 'Senegal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Niamey', 'country': 'Niger', 'facility': 'Hopital National', 'geoPoint': {'lat': 13.51366, 'lon': 2.1098}}, {'city': 'Dakar', 'country': 'Senegal', 'facility': "Clinic Notre Dame de L'Esperance, Thiaroye", 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}], 'overallOfficials': [{'name': 'Matthieu Million', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance publique des Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Hospitalo-Universitaire Méditerranée Infection', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}