Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530485
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Post Discharge Trial to Enhance Immunity in Severely Malnourished Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancing Immunity and Nutrition in Severely Malnourished Children Following Hospital Discharge a Two Arm Open-label Randomized Controlled Trial of Microbiota-Directed Food vs Zinc With Micronutrient Powder and Khichuri
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to evaluate the efficacy of microbiota-directed food in comparison to zinc with micronutrient powder and Khichuri on changes in circulating immune cells monocytes T cells B cells and NK cells in malnourished children after recovery from acute infection
The study aims to answer the research question
Does microbiota-directed food MDF compared to zinc with micronutrient powder MNP and Khichuri therapy enhance immunity in children with severe acute malnutrition The researcher will compare the effectiveness of microbiota-directed food MDF versus zinc with micronutrient powder MNP and Khichuri therapy to see if MDF enhances immunity in severely malnourished children
Severely malnourished children will
Receive microbiota-directed food MDF or zinc with micronutrient powder MNP and Khichuri every day for 12 weeks
Phenotyping of circulating immune cells NK cells T cells B cells will be conducted using flow cytometry and fluorescence-activated cell sorting techniques
The study aims to answer the research question
Does microbiota-directed food MDF compared to zinc with micronutrient powder MNP and Khichuri therapy enhance immunity in children with severe acute malnutrition The researcher will compare the effectiveness of microbiota-directed food MDF versus zinc with micronutrient powder MNP and Khichuri therapy to see if MDF enhances immunity in severely malnourished children
Severely malnourished children will
Receive microbiota-directed food MDF or zinc with micronutrient powder MNP and Khichuri every day for 12 weeks
Phenotyping of circulating immune cells NK cells T cells B cells will be conducted using flow cytometry and fluorescence-activated cell sorting techniques
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None