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

August 26, 2024 updated by: Sheila Isanaka, Epicentre
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7356

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Dietary supplement: 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.
Active Comparator: 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.
Dietary supplement: RUTF
RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter
Other Names:
  • Standard RUTF
Dietary supplement: RUSF
RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter
Other Names:
  • Standard RUSF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Programmatic recovery by 12 weeks from admission
Time Frame: 12 weeks
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
Time Frame: 24 weeks
Proportion of recovered SAM and MAM children with WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Default
Time Frame: 12 weeks
Defined as 2 consecutive missed scheduled program visits
12 weeks
Non-response
Time Frame: 12 weeks
Defined as WLZ < -2 or MUAC < 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks
12 weeks
Time to recovery
Time Frame: 12 weeks
Measured as days from admission to programmatic recovery among recovered children
12 weeks
For MAM children: Deterioration to SAM
Time Frame: 24 weeks
Weight-for-height z-score (WHZ) inferior to -3
24 weeks
Change in weight gain
Time Frame: From enrollment to 4, 8 and 12 weeks
Change in g/kg/day
From enrollment to 4, 8 and 12 weeks
Change in MUAC
Time Frame: From enrollment to 4, 8 and 12 weeks
Change in mm
From enrollment to 4, 8 and 12 weeks
Serious adverse events
Time Frame: 24 weeks
Combined safety endpoint, including hospitalization and death
24 weeks
Hospitalization
Time Frame: 24 weeks
Inpatient stay > 24h
24 weeks
Death
Time Frame: 24 weeks
All-cause mortality
24 weeks
Motor, cognitive, language, social-emotional, and mental health skills
Time Frame: 24 weeks
As measured by the Caregiver Reported Early Development Instrument (CREDI)
24 weeks
Cost effectiveness
Time Frame: 24 weeks
As defined by the incremental cost per child recovered and per child sustained recovered
24 weeks
Dietary intake
Time Frame: 24 weeks
As measured by 24h recall
24 weeks
Adherence
Time Frame: 12 weeks
Defined as the sum of sachets returned used divided by the total number of sachets distributed
12 weeks
Microbiome profile at enrollment, week 4, program discharge, and study discharge
Time Frame: 24 weeks
Defined as PCR-confirmed enteric viral, bacterial, and protozoan pathogens present
24 weeks
Plasma proteome profile at enrollment, week 4, program discharge, and study discharge
Time Frame: 24 weeks
Defined as circulating plasma proteins (IGFBP-2, thrombospondin-5, granulysin, GDF-15, and MMP-8)
24 weeks
Environmental enteric dysfunction at enrollment, program discharge, and study discharge
Time Frame: 24 weeks
Measured by anti-LPS IgA and IgG; anti-flagellin IgA and IgG; sCD14; I-FABP; myeloperoxidase (MPO); and calprotectin
24 weeks
Change of fat mass and fat-free mass at program discharge and study discharge
Time Frame: 24 weeks
Measured by deuterium dilution
24 weeks
Micronutrient status at enrollment, program discharge and study discharge
Time Frame: 24 weeks
Defined as ferritin; soluble transferrin binding protein; alpha-tocopherol; retinol; folate; and vitamin B12
24 weeks
Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only)
Time Frame: 24 weeks
As defined by T-cell receptor excision circles (TRECs) and kappa-receptor excision circles (KRECs)
24 weeks
Change in weight-for-length Z (WLZ)
Time Frame: From enrollment to 4, 8 and 12 weeks
Change in WLZ calculated using the 2006 WHO Growth Standards
From enrollment to 4, 8 and 12 weeks
Change in length-for-age Z (LAZ)
Time Frame: From enrollment to 4, 8 and 12 weeks
Change in LAZ calculated using the 2006 WHO Growth Standards
From enrollment to 4, 8 and 12 weeks
Change in weight-for-age Z (WAZ)
Time Frame: From enrollment to 4, 8 and 12 weeks
Change in WAZ calculated using the 2006 WHO Growth Standards
From enrollment to 4, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Epicentre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Epicentre, Niger
National Nutrition Direction, Niger
Ministry of Public Health and Social Affairs, Niger
Regional Direction of Public Health, Maradi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rebecca Grais, PhD, Epicentre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 823779-MDF Niger

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings