Community Health Center and Pediatric outpatient clinic at Mohammad Hoesin Hospital
Palembang, South Sumatra, 30000, Indonesia
NCT Number: NCT07089329
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.
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Notify Me12 month–59 month
All sexes
Interventional
Phase 3
Palembang, South Sumatra, 30000, Indonesia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily administration of Striatin extract will be carried out for 14 days. The dose is 1 sachet/day (5 g of Striatin) which dissolved in 10 mll of syrup.
Other names: Inbumin Forte
Daily administration of 1 sachet of placebo will be carried out for 14 days.
Time frame: Baseline, every three days, and Day 15.
Weight in grams
Time frame: Baseline and Day 15.
Prealbumin level
Time frame: Baseline and Day 15.
hsCRP level
Time frame: Baseline and Day 15.
Short chain fatty acids (SCFA)
Time frame: Baseline and Day 15.
Bacteroides-Firmicutes ratio (B/F ratio)
Time frame: Baseline and Day 15.
Brain Derived Neurotropic Factor (BDNF)
Universitas Sriwijaya
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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