NCT07089329

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universitas Sriwijaya · Academic / Other
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Detailed description

1. Children aged 12-59 months diagnosed with SAM based on weight-for-height Z score (WHZ) and/or mid-upper arm circumference (MUAC) will be included in the study. 2. Informed consents will be given and drawn from mother or legal caregiver. 3. Blood and stool samples will be taken before and after intervention in all participants. Markers which will be checked are: prealbumin, hsCRP, and brain-derived neurotropic factor (BDNF), from blood. Moreover, short-chain fatty acid (SCFA) and Bacteroides/Firmiculates ratio will be analyzed from stool. 4. Block randomization will be conducted to allocate participants into two groups: intervention group who receive Striatin supplementation, and control group who receive placebo. 5. The intervention will be given for 14 days. Neither researchers nor participants aware of the type of intervention (Striatin or placebo). 6. Both groups will receive standard F-100 formula or oral nutrition therapy (ONS) as nutritional treatment for SAM, vitamin C, vitamin B complex, and folic acid. 7. Intervention group will receive 1 sachet of Striatin and control group will receive 1 sachet of Placebo every 24 hours. Both Striatin and placebo will be dissolved in 10 ml of solvent syrup. The route of administration can be oral or via nasogastric tube. 8. Weight will be measured every three days, and any complaint or side effect that appeared will be recorded every day.

Conditions

• Severe Acute Malnutrition

Interventions

Type	Name	Description
DRUG	Striatin	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.
DRUG	Placebo	Daily administration of 1 sachet of placebo will be carried out for 14 days.

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-09-30
• Completion: 2025-10-01
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: Indonesia