Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305442
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-03-05
Brief Title:
Microbiota Directed Food for Children With Moderate Acute Malnutrition
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
Efficacy of Microbiota-Directed Food in Children With Moderate Acute Malnutrition in Dhaka Bangladesh
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 icddrb 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
Detailed Description:
Burden 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 MAM affects a significant number of children globally particularly in low- and middle-income countries where malnutrition is prevalent According to the 2022 Bangladesh Demographic and Health Survey 2022 BDHS 24 of children under the age of 5 are stunted while 11 are wasted The prevalence of worldwide MAM children is higher than that of children with SAM and 313 million under 5 children 70 was moderately wasted among all those children who were acutely malnourished in 2022 MAM children are found to be suffering from relative gut microbial immaturity which is related to their growth faltering Ready-to-use supplementary food RUSF is a key component of the outpatient treatment of MAM in community-based management RUSF being a ready-to-use food does not require preparation or refrigeration and provides the necessary nutrients and energy for recovery from MAM
Knowledge gap Researchers at icddrb in collaboration with Washington University in St Louis have developed a Microbiota-Directed Complementary Food MDCF formulation based on locally available food ingredients that has the potential to repair the gut microbiota of children with malnutrition Results from a recently conducted study of MDCF on Bangladeshi children suffering from MAM showed that the children who received the food exhibited significantly faster rates of ponderal growth compared to those treated with a standard ready-to-use supplementary food PR18073 Early evidence however is limited to a small sample of children with MAM
Relevance To meet the nutritional requirement of MAM children icddrb have come up with a novel intervention named microbiota-directed food MDF a ready-to-use supplementary food by modifying the original MDCF recipe to meet the nutritional requirement of MAM children as well as to make it align with the existing WHOUNICEF specifications for a nutritional intervention for treating acute malnutrition The proposed formulation of MDF with adequate calorie content will improve the nutritional status by modulating and improving the gut microbial dysbiosis that is present in MAM children Therefore 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
Hypothesis if any
The locally developed MDF would be proven beneficial in nutritional recovery repairing microbiota and restoring plasma biomarkers of healthy growth when compared to standard RUSF among children suffering from MAM
Objectives
Primary objectives
To assess the efficacy of MDF in improving the weight-for-length Z score WLZ of MAM children
Secondary
To investigate the efficacy of MDF in repairing the microbiota of MAM children
To measure the efficacy of MDF in improving the Weight-for-Age Z-score WAZ in children with MAM
To measure the efficacy of MDF in improving the Length-for-Age Z-score LAZ in children with MAM
To explore and validate the impact of MDF supplement in restoring plasma and fecal biomarkers
To monitor the change produced by MDF in rebalancing the body composition fat mass and fat-free mass
To explore the efficacy of MDF in improving the cognitive motor and language function of MAM children
Methods
Study Design This study will be a double-blind randomized controlled trial
Participants The trial will recruit 6-24-months-old children with Moderate Acute Malnutrition
Study Site Bauniabadh and the adjacent slum area of Mirpur in Dhaka city
Sample Size 230 2 arms 115 per arm
Intervention Children in one arm will receive the MDF and the children in the control arm will receive the conventional RUSF
The children will receive intervention for 12 weeks with either the MDF or RUSF
6-24-months children with MAM - 12 weeks intervention with MDF 12 weeks follow up
6-24-months children with MAM - 12 weeks intervention with RUSF 12 weeks follow up
Study Procedure Screening and enrolment of study participants will be done in Bauniabadh and the adjacent slum area of Mirpur in Dhaka city Initially 6-24-months-old children will be screened by the study health workers Parents of eligible children who meet the inclusion criterion will be approached about enrolment into the study A trained Field Research Assistant will explain the study in detail answer any questions from the parents and invite the parents to enroll the child in the study After acquiring consent from the parents at the beginning of the study information will be sought on the demographic characteristics families wealth standard of housing family structure home environment parental characteristics etc Morbidity data will be collected weekly during the intervention period and biweekly in the follow-up phase
In this study nutritional status will be assessed through anthropometry comparing with WHO growth reference standards BIA is a method of assessing body composition by measuring body fat in relation to lean body mass It is an integral part of a health and nutrition assessment BIA will be used to measure total fat and fat-free mass before and after treatment This non-invasive test simply involves the placement of electrodes on the persons hand and foot A low-level imperceptible electrical current is sent through the body The flow of the current is affected by the amount of water in the body The device measures how this signal is impeded through different types of tissue as it passes through the body and provides estimates of body water from which body fat is calculated
A food frequency questionnaire will be used to collect data on Infant and Young Child Feeding IYCF practices Food frequency data will be evaluated using the Minimum Acceptable Diet indicator as it meets standards for both minimum dietary diversity and minimum meal frequency
The Bayley Scales of Infant and Toddler Development BSID-IV will be used to assess the early childhood development cognitive motor and language development before and after the intervention The Caregiver Reported Early Development Instruments CREDI long form developed by Harvard University will also be used in this study 21
Blood samples will be collected before after the interventiontreatment and at the end of the follow-up period for measuring haemoglobin serum protein total protein and albumin thiamine zinc vitamin B12 vitamin D and folate levels
Non-diarrheal stool samples will be collected at enrolment then monthly during the intervention and follow-up phase from all the participants for measuring biomarkers of gut inflammation and assessment of the composition of gut microbiota and features of the microbiome
Oral swab samples will be collected by using commercial kit from each child at enrolment after the interventiontreatment and at the end of the follow-up period for measuring microbiota
Knowledge gap Researchers at icddrb in collaboration with Washington University in St Louis have developed a Microbiota-Directed Complementary Food MDCF formulation based on locally available food ingredients that has the potential to repair the gut microbiota of children with malnutrition Results from a recently conducted study of MDCF on Bangladeshi children suffering from MAM showed that the children who received the food exhibited significantly faster rates of ponderal growth compared to those treated with a standard ready-to-use supplementary food PR18073 Early evidence however is limited to a small sample of children with MAM
Relevance To meet the nutritional requirement of MAM children icddrb have come up with a novel intervention named microbiota-directed food MDF a ready-to-use supplementary food by modifying the original MDCF recipe to meet the nutritional requirement of MAM children as well as to make it align with the existing WHOUNICEF specifications for a nutritional intervention for treating acute malnutrition The proposed formulation of MDF with adequate calorie content will improve the nutritional status by modulating and improving the gut microbial dysbiosis that is present in MAM children Therefore 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
Hypothesis if any
The locally developed MDF would be proven beneficial in nutritional recovery repairing microbiota and restoring plasma biomarkers of healthy growth when compared to standard RUSF among children suffering from MAM
Objectives
Primary objectives
To assess the efficacy of MDF in improving the weight-for-length Z score WLZ of MAM children
Secondary
To investigate the efficacy of MDF in repairing the microbiota of MAM children
To measure the efficacy of MDF in improving the Weight-for-Age Z-score WAZ in children with MAM
To measure the efficacy of MDF in improving the Length-for-Age Z-score LAZ in children with MAM
To explore and validate the impact of MDF supplement in restoring plasma and fecal biomarkers
To monitor the change produced by MDF in rebalancing the body composition fat mass and fat-free mass
To explore the efficacy of MDF in improving the cognitive motor and language function of MAM children
Methods
Study Design This study will be a double-blind randomized controlled trial
Participants The trial will recruit 6-24-months-old children with Moderate Acute Malnutrition
Study Site Bauniabadh and the adjacent slum area of Mirpur in Dhaka city
Sample Size 230 2 arms 115 per arm
Intervention Children in one arm will receive the MDF and the children in the control arm will receive the conventional RUSF
The children will receive intervention for 12 weeks with either the MDF or RUSF
6-24-months children with MAM - 12 weeks intervention with MDF 12 weeks follow up
6-24-months children with MAM - 12 weeks intervention with RUSF 12 weeks follow up
Study Procedure Screening and enrolment of study participants will be done in Bauniabadh and the adjacent slum area of Mirpur in Dhaka city Initially 6-24-months-old children will be screened by the study health workers Parents of eligible children who meet the inclusion criterion will be approached about enrolment into the study A trained Field Research Assistant will explain the study in detail answer any questions from the parents and invite the parents to enroll the child in the study After acquiring consent from the parents at the beginning of the study information will be sought on the demographic characteristics families wealth standard of housing family structure home environment parental characteristics etc Morbidity data will be collected weekly during the intervention period and biweekly in the follow-up phase
In this study nutritional status will be assessed through anthropometry comparing with WHO growth reference standards BIA is a method of assessing body composition by measuring body fat in relation to lean body mass It is an integral part of a health and nutrition assessment BIA will be used to measure total fat and fat-free mass before and after treatment This non-invasive test simply involves the placement of electrodes on the persons hand and foot A low-level imperceptible electrical current is sent through the body The flow of the current is affected by the amount of water in the body The device measures how this signal is impeded through different types of tissue as it passes through the body and provides estimates of body water from which body fat is calculated
A food frequency questionnaire will be used to collect data on Infant and Young Child Feeding IYCF practices Food frequency data will be evaluated using the Minimum Acceptable Diet indicator as it meets standards for both minimum dietary diversity and minimum meal frequency
The Bayley Scales of Infant and Toddler Development BSID-IV will be used to assess the early childhood development cognitive motor and language development before and after the intervention The Caregiver Reported Early Development Instruments CREDI long form developed by Harvard University will also be used in this study 21
Blood samples will be collected before after the interventiontreatment and at the end of the follow-up period for measuring haemoglobin serum protein total protein and albumin thiamine zinc vitamin B12 vitamin D and folate levels
Non-diarrheal stool samples will be collected at enrolment then monthly during the intervention and follow-up phase from all the participants for measuring biomarkers of gut inflammation and assessment of the composition of gut microbiota and features of the microbiome
Oral swab samples will be collected by using commercial kit from each child at enrolment after the interventiontreatment and at the end of the follow-up period for measuring microbiota
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None