Efficacy of Striatin in Malnourished Children

April 27, 2026 updated by: Moretta Damayanti Fauzi, MD, Universitas Sriwijaya

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sumatra
      • Palembang, South Sumatra, Indonesia, 30000
        • Community Health Center and Pediatric outpatient clinic at Mohammad Hoesin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Subjects who require special anthropometric examinations (condition such as edema, organomegaly, amputation, cerebral palsy GMFCS > 2)
  3. Children who have history of severe hypersensitivity to snakehead fish and/or cow's milk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Inbumin Forte
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.
Drug: Placebo
Daily administration of 1 sachet of placebo will be carried out for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute and relative weight increase
Time Frame: Baseline, every three days, and Day 15.
Weight in grams
Baseline, every three days, and Day 15.
The change of Prealbumin
Time Frame: Baseline and Day 15.
Prealbumin level
Baseline and Day 15.
The change of hsCRP
Time Frame: Baseline and Day 15.
hsCRP level
Baseline and Day 15.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of SCFA
Time Frame: Baseline and Day 15.
Short chain fatty acids (SCFA)
Baseline and Day 15.
The change ofB/F ratio
Time Frame: Baseline and Day 15.
Bacteroides-Firmicutes ratio (B/F ratio)
Baseline and Day 15.
Level of neurocognitive biomarker.
Time Frame: Baseline and Day 15.
Brain Derived Neurotropic Factor (BDNF)
Baseline and Day 15.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sriwijaya

Collaborators

Dexa Medica Group

Investigators

  • Study Director: Agrifina Helga, Bachelor, University of Sriwijaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2025

Primary Completion (Actual)

February 25, 2026

Study Completion (Actual)

April 16, 2026

Study Registration Dates

First Submitted

June 17, 2025

First Submitted That Met QC Criteria

July 20, 2025

First Posted (Actual)

July 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Sriwijaya

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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