Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

Malnutrition, Child Clinical Trial

Official title:

Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382857
• Other study ID #: 823779-MDF Niger
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: April 2024
• Source: Epicentre
• Contact: Sheila Isanaka, ScD
• Email: sisanaka[@]hsph.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7356
• Est. completion date: February 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

Inclusion Criteria:

• for children with Severe Acute Malnutrition (SAM): MUAC < 115 mm and/or WLZ < -3 and/or mild (+) or moderate (++) edema

• for children with Moderate Acute Malnutrition (MAM): 115 mm = MUAC < 125 mm and/or -3 = WHZ < -2

• Caregiver providing informed consent

Exclusion Criteria:

• Medical complications requiring inpatient treatment, as identified by the national protocol

• Not eating/lack of appetite (as informed by appetite test and investigator judgement)

• Re-admission into the program within 2 months of previous default

• for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)

• for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)

• Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection

• Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)

• Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

Dietary Supplement:
• MDF
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.
• RUTF
RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter
• RUSF
RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter

Locations

Country	Name	City	State
Niger	Epicentre Niger	Maradi

Sponsors (5)

Lead Sponsor	Collaborator
Epicentre	Epicentre, Niger, Ministry of Public Health and Social Affairs, Niger, National Nutrition Direction, Niger, Regional Direction of Public Health, Maradi

Country where clinical trial is conducted

Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Programmatic recovery by 12 weeks from admission	Defined as the proportion of SAM and MAM children achieving a WLZ = -2 AND MUAC = 125mm AND no edema during 2 consecutive visits	12 weeks
Primary	Sustained recovery at 24 weeks from admission	Proportion of recovered SAM and MAM children with WLZ = -2 AND MUAC = 125mm AND no edema	24 weeks
Secondary	Default	Defined as 2 consecutive missed scheduled program visits	12 weeks
Secondary	Non-response	Defined as WLZ < -2 or MUAC < 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks	12 weeks
Secondary	Time to recovery	Measured as days from admission to programmatic recovery among recovered children	12 weeks
Secondary	For MAM children: Deterioration to SAM	Weight-for-height z-score (WHZ) inferior to -3	24 weeks
Secondary	Change in weight gain	Change in g/kg/day	From enrollment to 4, 8 and 12 weeks
Secondary	Change in weight-for-length Z (WLZ)	Change in WLZ calculated using the 2006 WHO Growth Standards	From enrollment to 4, 8 and 12 weeks
Secondary	Change in length-for-age Z (LAZ)	Change in LAZ calculated using the 2006 WHO Growth Standards	From enrollment to 4, 8 and 12 weeks
Secondary	Change in weight-for-age Z (WAZ)	Change in WAZ calculated using the 2006 WHO Growth Standards	From enrollment to 4, 8 and 12 weeks
Secondary	Change in MUAC	Change in mm	From enrollment to 4, 8 and 12 weeks
Secondary	Serious adverse events	Combined safety endpoint, including hospitalization and death	24 weeks
Secondary	Hospitalization	Inpatient stay > 24h	24 weeks
Secondary	Death	All-cause mortality	24 weeks
Secondary	Motor, cognitive, language, social-emotional, and mental health skills	As measured by the Caregiver Reported Early Development Instrument (CREDI)	24 weeks
Secondary	Cost effectiveness	As defined by the incremental cost per child recovered and per child sustained recovered	24 weeks
Secondary	Dietary intake	As measured by 24h recall	24 weeks
Secondary	Adherence	Defined as the sum of sachets returned used divided by the total number of sachets distributed	12 weeks
Secondary	Microbiome profile at enrollment, week 4, program discharge, and study discharge	Defined as PCR-confirmed enteric viral, bacterial, and protozoan pathogens present	24 weeks
Secondary	Plasma proteome profile at enrollment, week 4, program discharge, and study discharge	Defined as circulating plasma proteins (IGFBP-2, thrombospondin-5, granulysin, GDF-15, and MMP-8)	24 weeks
Secondary	Environmental enteric dysfunction at enrollment, program discharge, and study discharge	Measured by anti-LPS IgA and IgG; anti-flagellin IgA and IgG; sCD14; I-FABP; myeloperoxidase (MPO); and calprotectin	24 weeks
Secondary	Change of fat mass and fat-free mass at program discharge and study discharge	Measured by deuterium dilution	24 weeks
Secondary	Micronutrient status at enrollment, program discharge and study discharge	Defined as ferritin; soluble transferrin binding protein; alpha-tocopherol; retinol; folate; and vitamin B12	24 weeks
Secondary	Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only)	As defined by T-cell receptor excision circles (TRECs) and kappa-receptor excision circles (KRECs)	24 weeks