Microbiota Directed Food for Children With Severe Acute Malnutrition

NCT06308848 | Not Yet Recruiting

• 1 other identifier: PR-22077
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Severe acute malnutrition (SAM) 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 SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF.

Conditions

Severe Acute Malnutrition

Keywords

Microbiota directed food; SAM; Gut microbiota; 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 at enrolment, every two weeks interval during the intervention phase and then monthly for the first three months of the follow up period and then at three monthly for the rest of the period until end of the study.

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

Secondary Outcomes (5)

• Gut microbial community repair

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

• Improvement in the levels of plasma protein biomarkers of healthy growth

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

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

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

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

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

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

  Baseline to 12 weeks of intervention followed by 3 months of follow-up

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-month period.

Dietary Supplement: Microbiota-Directed Food

Ready-to-Use Therapeutic Food (RUTF)

ACTIVE COMPARATOR

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

Dietary Supplement: Ready-to-Use Therapeutic 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 Therapeutic Food DIETARY_SUPPLEMENT

RUTF is standard ready-to-use therapeutic food for SAM children aged 6 months and above.

Also known as: RUTF

Ready-to-Use Therapeutic Food (RUTF)

Eligibility Criteria

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

You may qualify if:

• The trial will include SAM children of either sex without any medical complication
• Children aged between 6-\<24 months and with MUAC \<115 mm and/or WLZ \<-3

You may not qualify if:

• Children are not suffering from SAM.
• Children with bi-pedal oedema.
• Failed to obtain consent for study participation from parents or legal guardian.
• Suffering from any chronic illness(es) or having severe anemia (\< 8 g/dl).
• History of using antibiotics in the past seven days.
• Children participating in other food intervention programs.
• Children having known history of soy, peanut or milk protein allergy.
• Children who will not pass appetite test.

Sponsors & Collaborators

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

Study Sites (1)

Kurigram Study site

Kurigrām, Bangladesh

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Interventions

milk-derived factor

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Md Hasan Hafizur Rahman, MPH, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md Hasan Hafizur Rahman, MPH, MBBS

CONTACT

01813333444; hasan.hafizur@icddrb.org

Ishita Mostafa, BDS, MPH

CONTACT

01755512359; ishita.mostafa@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: Randomized controlled trial (Proof of concept study)

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 13, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)