Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-20 @ 3:37 PM
Study NCT ID:
NCT06382857
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2024-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C074705', 'term': 'milk-derived factor'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7356}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Programmatic recovery by 12 weeks from admission', 'timeFrame': '12 weeks', 'description': 'Defined as the proportion of SAM and MAM children achieving a WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema during 2 consecutive visits'}, {'measure': 'Sustained recovery at 24 weeks from admission', 'timeFrame': '24 weeks', 'description': 'Proportion of recovered SAM and MAM children with WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema'}], 'secondaryOutcomes': [{'measure': 'Default', 'timeFrame': '12 weeks', 'description': 'Defined as 2 consecutive missed scheduled program visits'}, {'measure': 'Non-response', 'timeFrame': '12 weeks', 'description': 'Defined as WLZ \\< -2 or MUAC \\< 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks'}, {'measure': 'Time to recovery', 'timeFrame': '12 weeks', 'description': 'Measured as days from admission to programmatic recovery among recovered children'}, {'measure': 'For MAM children: Deterioration to SAM', 'timeFrame': '24 weeks', 'description': 'Weight-for-height z-score (WHZ) inferior to -3'}, {'measure': 'Change in weight gain', 'timeFrame': 'From enrollment to 4, 8 and 12 weeks', 'description': 'Change in g/kg/day'}, {'measure': 'Change in weight-for-length Z (WLZ)', 'timeFrame': 'From enrollment to 4, 8 and 12 weeks', 'description': 'Change in WLZ calculated using the 2006 WHO Growth Standards'}, {'measure': 'Change in length-for-age Z (LAZ)', 'timeFrame': 'From enrollment to 4, 8 and 12 weeks', 'description': 'Change in LAZ calculated using the 2006 WHO Growth Standards'}, {'measure': 'Change in weight-for-age Z (WAZ)', 'timeFrame': 'From enrollment to 4, 8 and 12 weeks', 'description': 'Change in WAZ calculated using the 2006 WHO Growth Standards'}, {'measure': 'Change in MUAC', 'timeFrame': 'From enrollment to 4, 8 and 12 weeks', 'description': 'Change in mm'}, {'measure': 'Serious adverse events', 'timeFrame': '24 weeks', 'description': 'Combined safety endpoint, including hospitalization and death'}, {'measure': 'Hospitalization', 'timeFrame': '24 weeks', 'description': 'Inpatient stay \\> 24h'}, {'measure': 'Death', 'timeFrame': '24 weeks', 'description': 'All-cause mortality'}, {'measure': 'Motor, cognitive, language, social-emotional, and mental health skills', 'timeFrame': '24 weeks', 'description': 'As measured by the Caregiver Reported Early Development Instrument (CREDI)'}, {'measure': 'Cost effectiveness', 'timeFrame': '24 weeks', 'description': 'As defined by the incremental cost per child recovered and per child sustained recovered'}, {'measure': 'Dietary intake', 'timeFrame': '24 weeks', 'description': 'As measured by 24h recall'}, {'measure': 'Adherence', 'timeFrame': '12 weeks', 'description': 'Defined as the sum of sachets returned used divided by the total number of sachets distributed'}, {'measure': 'Microbiome profile at enrollment, week 4, program discharge, and study discharge', 'timeFrame': '24 weeks', 'description': 'Defined as PCR-confirmed enteric viral, bacterial, and protozoan pathogens present'}, {'measure': 'Plasma proteome profile at enrollment, week 4, program discharge, and study discharge', 'timeFrame': '24 weeks', 'description': 'Defined as circulating plasma proteins (IGFBP-2, thrombospondin-5, granulysin, GDF-15, and MMP-8)'}, {'measure': 'Environmental enteric dysfunction at enrollment, program discharge, and study discharge', 'timeFrame': '24 weeks', 'description': 'Measured by anti-LPS IgA and IgG; anti-flagellin IgA and IgG; sCD14; I-FABP; myeloperoxidase (MPO); and calprotectin'}, {'measure': 'Change of fat mass and fat-free mass at program discharge and study discharge', 'timeFrame': '24 weeks', 'description': 'Measured by deuterium dilution'}, {'measure': 'Micronutrient status at enrollment, program discharge and study discharge', 'timeFrame': '24 weeks', 'description': 'Defined as ferritin; soluble transferrin binding protein; alpha-tocopherol; retinol; folate; and vitamin B12'}, {'measure': 'Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only)', 'timeFrame': '24 weeks', 'description': 'As defined by T-cell receptor excision circles (TRECs) and kappa-receptor excision circles (KRECs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Malnutrition', 'SAM', 'MAM', 'Child', 'MDF', 'Microbiome'], 'conditions': ['Malnutrition, Child']}, 'descriptionModule': {'briefSummary': 'This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \\< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* for children with Severe Acute Malnutrition (SAM): MUAC \\< 115 mm and/or WLZ \\< -3 and/or mild (+) or moderate (++) edema\n* for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC \\< 125 mm and/or -3 ≤ WHZ \\< -2\n* Caregiver providing informed consent\n\nExclusion Criteria:\n\n* Medical complications requiring inpatient treatment, as identified by the national protocol\n* Not eating/lack of appetite (as informed by appetite test and investigator judgement)\n* Re-admission into the program within 2 months of previous default\n* for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)\n* for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)\n* Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection\n* Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)\n* Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community'}, 'identificationModule': {'nctId': 'NCT06382857', 'briefTitle': 'Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'Epicentre'}, 'officialTitle': 'Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition', 'orgStudyIdInfo': {'id': '823779-MDF Niger'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microbiome directed food (MDF)', 'description': 'The MDF in this study was developed by the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,B). This MDF is the lead icddr,B prototype that has demonstrated the strongest increase in biomarkers critical to growth, including growth hormone receptor and leptin, and re-establishment of the maturity of the microbiome among moderately malnourished children. Ingredients include chickpea flour, soy flour, peanut paste, green banana powder, sugar, oil, and micronutrients. The same MDF is provided for the treatment of SAM and MAM at modified doses.', 'interventionNames': ['Dietary Supplement: MDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard nutritional treatment (RUTF/RUSF)', 'description': "The standard RUTF used in this study for the treatment of SAM is Plumpy'Nut (Nutriset France). RUTF is a specialized therapeutic food that can be consumed without preparation and meets the nutritional requirements for the recovery of SAM. Ingredients include oil, peanut, skimmed milk powder, sugar and micronutrients. The standard RUSF used in this study is Plumpy'Sup (Nutriset France). RUSF is a lipid-based nutritional supplement with a high vitamin and mineral content, specifically designed for the treatment of MAM. Ingredients include oil, peanut, skimmed milk powder, sugar and micronutrients.", 'interventionNames': ['Dietary Supplement: RUTF', 'Dietary Supplement: RUSF']}], 'interventions': [{'name': 'MDF', 'type': 'DIETARY_SUPPLEMENT', 'description': 'MDF will be provided to children on a weekly basis for children with SAM and bi-weekly basis for children with MAM at the health center until programmatic recovery but not thereafter.', 'armGroupLabels': ['Microbiome directed food (MDF)']}, {'name': 'RUTF', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Standard RUTF'], 'description': 'RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter', 'armGroupLabels': ['Standard nutritional treatment (RUTF/RUSF)']}, {'name': 'RUSF', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Standard RUSF'], 'description': 'RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter', 'armGroupLabels': ['Standard nutritional treatment (RUTF/RUSF)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maradi', 'status': 'RECRUITING', 'country': 'Niger', 'contacts': [{'name': 'Ousmane Guindo, MD', 'role': 'CONTACT', 'email': 'ousmane.guindo@epicentre.msf.org'}, {'name': 'Ibrahim Ngoumboute, MD', 'role': 'CONTACT', 'email': 'ibrahim.ngoumboute@epicentre.msf.org'}], 'facility': 'Epicentre Niger', 'geoPoint': {'lat': 13.5, 'lon': 7.10174}}], 'centralContacts': [{'name': 'Sheila Isanaka, ScD', 'role': 'CONTACT', 'email': 'sisanaka@hsph.harvard.edu'}], 'overallOfficials': [{'name': 'Rebecca Grais, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Epicentre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epicentre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Epicentre, Niger', 'class': 'UNKNOWN'}, {'name': 'National Nutrition Direction, Niger', 'class': 'UNKNOWN'}, {'name': 'Ministry of Public Health and Social Affairs, Niger', 'class': 'UNKNOWN'}, {'name': 'Regional Direction of Public Health, Maradi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sheila Isanaka', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}