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NCT Number: NCT06382857

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

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.

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Key information

Conditions

Malnutrition, Child Child Nutrition Disorders Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDF

Dietary Supplement

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

Dietary Supplement

RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter

Other names: Standard RUTF

RUSF

Dietary Supplement

RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter

Other names: Standard RUSF

Primary outcomes

  1. Programmatic recovery by 12 weeks from admission

    Time frame: 12 weeks

    Defined as the proportion of SAM and MAM children achieving a WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema during 2 consecutive visits

  2. Sustained recovery at 24 weeks from admission

    Time frame: 24 weeks

    Proportion of recovered SAM and MAM children with WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema

Secondary outcomes

  1. Default

    Time frame: 12 weeks

    Defined as 2 consecutive missed scheduled program visits

  2. Non-response

    Time frame: 12 weeks

    Defined as WLZ < -2 or MUAC < 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks

  3. Time to recovery

    Time frame: 12 weeks

    Measured as days from admission to programmatic recovery among recovered children

  4. For MAM children: Deterioration to SAM

    Time frame: 24 weeks

    Weight-for-height z-score (WHZ) inferior to -3

  5. Change in weight gain

    Time frame: From enrollment to 4, 8 and 12 weeks

    Change in g/kg/day

  6. Change in weight-for-length Z (WLZ)

    Time frame: From enrollment to 4, 8 and 12 weeks

    Change in WLZ calculated using the 2006 WHO Growth Standards

  7. Change in length-for-age Z (LAZ)

    Time frame: From enrollment to 4, 8 and 12 weeks

    Change in LAZ calculated using the 2006 WHO Growth Standards

  8. Change in weight-for-age Z (WAZ)

    Time frame: From enrollment to 4, 8 and 12 weeks

    Change in WAZ calculated using the 2006 WHO Growth Standards

  9. Change in MUAC

    Time frame: From enrollment to 4, 8 and 12 weeks

    Change in mm

  10. Serious adverse events

    Time frame: 24 weeks

    Combined safety endpoint, including hospitalization and death

  11. Hospitalization

    Time frame: 24 weeks

    Inpatient stay > 24h

  12. Death

    Time frame: 24 weeks

    All-cause mortality

  13. Motor, cognitive, language, social-emotional, and mental health skills

    Time frame: 24 weeks

    As measured by the Caregiver Reported Early Development Instrument (CREDI)

  14. Cost effectiveness

    Time frame: 24 weeks

    As defined by the incremental cost per child recovered and per child sustained recovered

  15. Dietary intake

    Time frame: 24 weeks

    As measured by 24h recall

  16. Adherence

    Time frame: 12 weeks

    Defined as the sum of sachets returned used divided by the total number of sachets distributed

  17. Microbiome profile at enrollment, week 4, program discharge, and study discharge

    Time frame: 24 weeks

    Defined as PCR-confirmed enteric viral, bacterial, and protozoan pathogens present

  18. Plasma proteome profile at enrollment, week 4, program discharge, and study discharge

    Time frame: 24 weeks

    Defined as circulating plasma proteins (IGFBP-2, thrombospondin-5, granulysin, GDF-15, and MMP-8)

  19. Environmental enteric dysfunction at enrollment, program discharge, and study discharge

    Time frame: 24 weeks

    Measured by anti-LPS IgA and IgG; anti-flagellin IgA and IgG; sCD14; I-FABP; myeloperoxidase (MPO); and calprotectin

  20. Change of fat mass and fat-free mass at program discharge and study discharge

    Time frame: 24 weeks

    Measured by deuterium dilution

  21. Micronutrient status at enrollment, program discharge and study discharge

    Time frame: 24 weeks

    Defined as ferritin; soluble transferrin binding protein; alpha-tocopherol; retinol; folate; and vitamin B12

  22. Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only)

    Time frame: 24 weeks

    As defined by T-cell receptor excision circles (TRECs) and kappa-receptor excision circles (KRECs)

Study contacts

Contact information is provided by the study sponsor or research team.

Sheila Isanaka, ScD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Epicentre, Niger
  • Ministry of Public Health and Social Affairs, Niger
  • National Nutrition Direction, Niger
  • Regional Direction of Public Health, Maradi

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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