Microbiota Directed Food for Children With Moderate Acute Malnutrition

NCT06305442 | Not Yet Recruiting

• 1 other identifier: PR-24031
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food. The investigator propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF.

Conditions

Moderate Acute Malnutrition

Keywords

Microbiota Directed Food; Gut microbiota; MAM; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Mean change in Weight-for-Length Z-score (WLZ)

  In this study, nutritional status will be assessed through anthropometric measurement before enrolment, then biweekly till completion of intervention and monthly during 12 weeks follow up.

  Baseline to 12 weeks of intervention followed by 12 weeks of follow-up

Secondary Outcomes (6)

• Microbial community repair

  Baseline to 12 weeks of intervention followed by 12 weeks of follow-up

• Validated plasma and faecal biomarkers of health status (prioritized Luminex/ELISA panel including mediators of growth, systemic inflammation, gut inflammation/entero-pathogen burden)

  Baseline to 12 weeks of intervention followed by 12 weeks of follow-up

• Mean change in Weight-for-Age Z-score (WAZ)

  Baseline to 12 weeks of intervention followed by 12 weeks of follow-up

• Mean change in Length-for-Age Z-score (LAZ)

  Baseline to 12 weeks of intervention followed by 12 weeks of follow-up

• Mean change in body composition (% body fat mass and % fat-free mass)

  Baseline to 12 weeks of intervention

Study Arms (2)

Microbiota Directed Food (MDF)

EXPERIMENTAL

Each participant will receive 12 weeks of MDF supplement. After finishing the intervention phase, he/she will be followed-up for a 12-week period.

Dietary Supplement: Microbiota-Directed Food

Ready-to-Use Supplementary Food (RUSF)

ACTIVE COMPARATOR

Each participant will receive 12 weeks of RUSF supplement. After finishing the intervention phase, he/she will be followed-up for a 12-week period.

Dietary Supplement: Ready-to-Use Supplementary Food

Interventions

Microbiota-Directed Food DIETARY_SUPPLEMENT

MDF is a microbiota directed food for malnourished children aged 6 months and above. It is in sachet form. The sachet contains 92 gm of supplements and provides approximately 506 kcal.

Also known as: MDF

Microbiota Directed Food (MDF)

Ready-to-Use Supplementary Food DIETARY_SUPPLEMENT

RUSF is standard ready-to-use supplementary food for MAM children aged 6 months and above.

Also known as: RUSF

Ready-to-Use Supplementary Food (RUSF)

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent(s) willing to sign consent form
• Children aged 6-24 months
• WLZ score \<-2 to ≥-3 and/or MUAC ≥115 mm to \<125 mm without bilateral pedal edema at the time of randomization

You may not qualify if:

• Medical conditions: Malnourished children with complications requiring acute phase treatment in a hospital, children with tuberculosis or any chronic illness(es).
• Severe anaemia (\< 8 gm/dl)
• Antibiotic use (within last 7 days before the onset of intervention)
• Receiving concurrent treatment for another condition
• children participating in other food intervention program

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Mirpur Study site

Dhaka, Bangladesh

Location

MeSH Terms

Interventions

milk-derived factor

Study Officials

• Ishita Mostafa, BDS, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ishita Mostafa, BDS, MPH

CONTACT

01755512359; ishita.mostafa@icddrb.org

Tahmeed Ahmed, MBBS, PhD

CONTACT

tahmeed@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomized, parallel group, clinical trial

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: April 15, 2024
• Primary Completion: October 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)