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OpenTrials
Completed

NCT Number: NCT07089329

Efficacy of Striatin in Malnourished Children

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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Key information

Age range

12 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Community Health Center and Pediatric outpatient clinic at Mohammad Hoesin Hospital

Palembang, South Sumatra, 30000, Indonesia

About this study

  • 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.
  • Informed consents will be given and drawn from mother or legal caregiver.
  • 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.
  • Block randomization will be conducted to allocate participants into two groups: intervention group who receive Striatin supplementation, and control group who receive placebo.
  • The intervention will be given for 14 days. Neither researchers nor participants aware of the type of intervention (Striatin or placebo).
  • 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.
  • 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.
  • Weight will be measured every three days, and any complaint or side effect that appeared will be recorded every day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe acute malnutrition (SAM) children based on WHZ and/or MUAC
  • Consents are given by parents/caregivers.

Exclusion criteria

  • 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.

Treatment and study plan

Striatin

Drug

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

Placebo

Drug

Daily administration of 1 sachet of placebo will be carried out for 14 days.

Primary outcomes

  1. Absolute and relative weight increase

    Time frame: Baseline, every three days, and Day 15.

    Weight in grams

  2. The change of Prealbumin

    Time frame: Baseline and Day 15.

    Prealbumin level

  3. The change of hsCRP

    Time frame: Baseline and Day 15.

    hsCRP level

Secondary outcomes

  1. The change of SCFA

    Time frame: Baseline and Day 15.

    Short chain fatty acids (SCFA)

  2. The change ofB/F ratio

    Time frame: Baseline and Day 15.

    Bacteroides-Firmicutes ratio (B/F ratio)

  3. Level of neurocognitive biomarker.

    Time frame: Baseline and Day 15.

    Brain Derived Neurotropic Factor (BDNF)

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Collaborators

  • Dexa Medica Group

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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