Efficacy of Striatin in Malnourished Children
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
Universitas Sriwijaya
30 participants
May 20, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Severe acute malnutrition (SAM) children based on WHZ and/or MUAC
- Consents are given by parents/caregivers.
Exclusion Criteria3
- SAM children with malignancy, liver cirrhosis, acute liver failure, severe kidney disorders, acute and chronic infections that attack the liver or other severe infections that require special treatment.
- Subjects who require special anthropometric examinations (condition such as edema, organomegaly, amputation, cerebral palsy GMFCS > 2)
- Children who have history of severe hypersensitivity to snakehead fish and/or cow's milk.
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Interventions
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.
Daily administration of 1 sachet of placebo will be carried out for 14 days.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07089329