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

NCT ID: NCT06382857

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2026-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microbiome directed food (MDF)

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.

Group Type: EXPERIMENTAL

MDF

Intervention Type: 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.

Standard nutritional treatment (RUTF/RUSF)

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.

Group Type: ACTIVE_COMPARATOR

RUTF

Intervention Type: DIETARY_SUPPLEMENT

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

RUSF

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

RUTF

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

Intervention Type: DIETARY_SUPPLEMENT

RUSF

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Standard RUTF; Standard RUSF

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epicentre, Niger

UNKNOWN

Sponsor Role: collaborator

National Nutrition Direction, Niger

UNKNOWN

Sponsor Role: collaborator

Ministry of Public Health and Social Affairs, Niger

UNKNOWN

Sponsor Role: collaborator

Regional Direction of Public Health, Maradi

UNKNOWN

Sponsor Role: collaborator

Epicentre

OTHER

Sponsor Role: lead

Responsible Party

Sheila Isanaka

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Grais, PhD

Role: STUDY_CHAIR

Epicentre

Locations

Epicentre Niger

Maradi, , Niger

Site Status: RECRUITING

Countries

Niger

Central Contacts

Sheila Isanaka, ScD

Role: CONTACT

sisanaka@hsph.harvard.edu

Facility Contacts

Ousmane Guindo, MD

Role: primary

ousmane.guindo@epicentre.msf.org

Ibrahim Ngoumboute, MD

Role: backup

ibrahim.ngoumboute@epicentre.msf.org

Other Identifiers

823779-MDF Niger

Identifier Type: -

Identifier Source: org_study_id