Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-30 @ 1:33 AM
Study NCT ID:
NCT06722404
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2024-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synbiotics for the Management of Malnutrition (Children)
Sponsor:
University of Veterinary and Animal Sciences, Lahore - Pakistan
Organization:
Study Overview
Official Title:
Effect of Synbiotics on Hematological Indices of Malnourished Children
Status:
COMPLETED
Status Verified Date:
2024-12
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:
In this study, dose related effect of synbiotics on the blood indices of severely acute malnourished (SAM) children (6-59 months) was carried out in hospitalized setting. Fifty SAM children were enrolled in a double-blind, randomized design.
Detailed Description:
The study was done at Nutrition Rehabilitation Unit (NRU), Department of Social \& Preventive Pediatrics, Mayo Hospital, Lahore, Pakistan, a Tertiary Care large urban teaching and referral hospital and was approved by human ethics Institutional Review Board (IRB) .Galacto-oligosaccharides (Oligomate) as prebiotics were procured from Yakult Pharmaceutical Industry, Japan and Resiton (lactobacillus paracasei subsp. paracasei) as probiotics were procured from MakNsons Pharmaceutical Industry, Italy. In the present study we enrolled 50 severely acute malnourished (SAM) in patients of 6-59 months of age while follow-up treatment was given at the out-patient department. We define SAM as weight-for height of less than 70% of the median, nutritional edema (Kwashiorkor), or both, mid-upper arm circumference (MUAC) of less than 11.5cm. Anthropometry protocols were followed by research standards
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PIN No. 085-14090-AV5-176 | OTHER_GRANT | Higher Education Commission (HEC), Pakistan | View |