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

NCT06382857 | Recruiting DMC

• 1 other identifier: 823779-MDF Niger
• Study Type: interventional
• Target: 7,356
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malnutrition, Child

Keywords

Malnutrition; SAM; MAM; Child; MDF; Microbiome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (22)

• Default

  12 weeks

• Non-response

  12 weeks

• Time to recovery

  12 weeks

• For MAM children: Deterioration to SAM

  24 weeks

• Change in weight gain

  From enrollment to 4, 8 and 12 weeks

Study Arms (2)

Microbiome directed food (MDF)

EXPERIMENTAL

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.

Dietary Supplement: MDF

Standard nutritional treatment (RUTF/RUSF)

ACTIVE COMPARATOR

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.

Dietary Supplement: RUTF; Dietary Supplement: RUSF

Interventions

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.

Microbiome directed food (MDF)

RUTF DIETARY_SUPPLEMENT

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

Also known as: Standard RUTF

Standard nutritional treatment (RUTF/RUSF)

RUSF DIETARY_SUPPLEMENT

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

Also known as: Standard RUSF

Standard nutritional treatment (RUTF/RUSF)

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Epicentre Niger

Maradi, Niger

RECRUITING

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition

Interventions

milk-derived factor

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Rebecca Grais, PhD

  Epicentre

  STUDY CHAIR

Central Study Contacts

Sheila Isanaka, ScD

CONTACT

sisanaka@hsph.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 24, 2024
• Study Start: May 2, 2024
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NI (1)