Efficacy of Striatin on Weight Gain, Improvement of Acute Phase Inflammatory Marker, and the Change of Firmicutes Bacteroidetes (F/B), SCFA, BDNF Proteins in Malnourished Children: A Preliminary Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a double-blind randomized-controlled clinical trial to identify the effect of Striatin (snakehead fish extract) supplementation in increasing body weight, improving acute inflammatory markers and microbiota profiles in children with severe acute malnutrition (SAM) treating with standard nutritional therapy. The main questions to answer are: Does Striatin supplementation effective in increasing body weight and improving acute inflammatory markers in SAM children? What are the adverse events of Striatin supplementation in SAM children? Researchers will compare Striatin supplementation and placebo (a look-alike substance that contains no drug) to identify the increase of body weight, improvement of acute inflammatory markers and microbiota profiles.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 4
Healthy Volunteers: f
View:
• Severe acute malnutrition (SAM) children based on WHZ and/or MUAC
• Consents are given by parents/caregivers.
Locations
Other Locations
Indonesia
Community Health Center and Pediatric outpatient clinic at Mohammad Hoesin Hospital
RECRUITING
Palembang
Contact Information
Primary
Agrifina H Pratiwi, Bachelor
agrifinahelga@gmail.com
+628117811765
Backup
Moretta D Fauzi, Master
md4eay@gmail.com
081387743885
Time Frame
Start Date:2025-05-20
Estimated Completion Date:2025-10-01
Participants
Target number of participants:30
Treatments
Experimental: Striatin
Participant in the intervention group will consume 1 sachet of the study product daily for 14 days. Each sachet contains 5 g of Striatin extract and 0.25 g of curcumin, to be dissolved in 10 ml of solvent syrup. The product is white in powder form, has sweet taste, and turns into a light-orange liquid after dissolution.
Placebo_comparator: Placebo
Participant in the control group will consume 1 sachet of Placebo daily for 14 days. Each sachet contains 4.89 g Mannitol, also to be dissolved in 10 ml of solvent syrup. The color and taste of the placebo match those of the intervention product to maintain blinding.