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Malnutrition, ChildNCT06382857

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

A study testing MDF, RUTF and RUSF in people with Malnutrition, Child, run by Epicentre at 1 site in Niger.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 6 to 23 months
Conditions the study is for
Malnutrition, Child
What is being tested?
MDF, RUTF and RUSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,356 participants
Where
1 siteNiger
Study dates
2 May 2024to 1 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 23 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sheila Isanaka, ScD contact

sisanaka@hsph.harvard.edu

Niger1 site, 1 recruiting

  • Epicentre Niger

    Maradi

    Ousmane Guindo, MD, ousmane.guindo@epicentre.msf.org

    Ibrahim Ngoumboute, MD, ibrahim.ngoumboute@epicentre.msf.org

    Recruiting

Other trials in Niger

About this study

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.

Being tested
MDF, RUTF, RUSF
Keywords
Malnutrition, SAM, MAM, Child, MDF, Microbiome
Medical subject headings
Child Nutrition Disorders, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDFDietary 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.

  • RUTFDietary supplement

    Also called Standard RUTF

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

  • RUSFDietary supplement

    Also called Standard RUSF

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

Study groups in NCT06382857
Study groupRoleWhat they receive
Microbiome directed food (MDF)ExperimentalThe 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.
Receives: Dietary Supplement: MDF
Standard nutritional treatment (RUTF/RUSF)Active comparatorThe 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.
Receives: Dietary Supplement: RUTF; Dietary Supplement: RUSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. Sustained recovery at 24 weeks from admission

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

    Measured: 24 weeks

Secondary outcomes (22)

  1. Default

    Defined as 2 consecutive missed scheduled program visits

    Measured: 12 weeks

  2. Non-response

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

    Measured: 12 weeks

  3. Time to recovery

    Measured as days from admission to programmatic recovery among recovered children

    Measured: 12 weeks

  4. For MAM children: Deterioration to SAM

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

    Measured: 24 weeks

  5. Change in weight gain

    Change in g/kg/day

    Measured: From enrollment to 4, 8 and 12 weeks

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

    Change in WLZ calculated using the 2006 WHO Growth Standards

    Measured: From enrollment to 4, 8 and 12 weeks

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

    Change in LAZ calculated using the 2006 WHO Growth Standards

    Measured: From enrollment to 4, 8 and 12 weeks

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

    Change in WAZ calculated using the 2006 WHO Growth Standards

    Measured: From enrollment to 4, 8 and 12 weeks

  9. Change in MUAC

    Change in mm

    Measured: From enrollment to 4, 8 and 12 weeks

  10. Serious adverse events

    Combined safety endpoint, including hospitalization and death

    Measured: 24 weeks

  11. Hospitalization

    Inpatient stay > 24h

    Measured: 24 weeks

  12. Death

    All-cause mortality

    Measured: 24 weeks

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

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

    Measured: 24 weeks

  14. Cost effectiveness

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

    Measured: 24 weeks

  15. Dietary intake

    As measured by 24h recall

    Measured: 24 weeks

  16. Adherence

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

    Measured: 12 weeks

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

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

    Measured: 24 weeks

  18. 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)

    Measured: 24 weeks

  19. 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

    Measured: 24 weeks

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

    Measured by deuterium dilution

    Measured: 24 weeks

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

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

    Measured: 24 weeks

  22. 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)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study start2 May 2024
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7,356 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06382857
Sponsor's protocol ID
823779-MDF Niger
Status last verified
Aug 2024
First submitted
16 Apr 2024
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MDF, RUTF and RUSF in people with Malnutrition, Child, run by Epicentre at 1 site in Niger.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Niger. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sheila Isanaka, ScD (sisanaka@hsph.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Programmatic recovery by 12 weeks from admission (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06382857.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.

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