Efficacy of Striatin in Malnourished Children

NCT07089329 | Completed Phase 3 DMC

• 1 other identifier: University of Sriwijaya
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Acute Malnutrition

Keywords

Striatin; Malnutrition; Acute inflammation markers; Microbiota; Children

Outcome Measures

Primary Outcomes (3)

• Absolute and relative weight increase

  Weight in grams

  Baseline, every three days, and Day 15.

• The change of Prealbumin

  Prealbumin level

  Baseline and Day 15.

• The change of hsCRP

  hsCRP level

  Baseline and Day 15.

Secondary Outcomes (3)

• The change of SCFA

  Baseline and Day 15.

• The change ofB/F ratio

  Baseline and Day 15.

• Level of neurocognitive biomarker.

  Baseline and Day 15.

Study Arms (2)

Striatin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Inbumin Forte

Striatin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sriwijaya: lead
• Dexa Medica Group: collaborator

Study Sites (1)

Community Health Center and Pediatric outpatient clinic at Mohammad Hoesin Hospital

Palembang, South Sumatra, 30000, Indonesia

Location

Related Publications (2)

• Sigh S, Roos N, Chamnan C, Laillou A, Prak S, Wieringa FT. Effectiveness of a Locally Produced, Fish-Based Food Product on Weight Gain among Cambodian Children in the Treatment of Acute Malnutrition: A Randomized Controlled Trial. Nutrients. 2018 Jul 16;10(7):909. doi: 10.3390/nu10070909.

  PMID: 30012981 BACKGROUND

• Puji Rahayu, Faustine Marcelline, Erna Sulistyaningrum, Maggy Thenawidjaja Suhartono, Raymond Rubianto Tjandrawinata, Potential effect of striatin (DLBS0333), a bioactive protein fraction isolated from Channa striata for wound treatment, Asian Pacific Journal of Tropical Biomedicine, Volume 6, Issue 12, 2016, Pages 1001-1007, ISSN 2221-1691, https://doi.org/10.1016/j.apjtb.2016.10.008. (https://www.sciencedirect.com/science/article/pii/S2221169115308534)

  BACKGROUND

MeSH Terms

Conditions

Severe Acute Malnutrition; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Agrifina Helga, Bachelor

  University of Sriwijaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We use block randomization (http://www.randomization.com) to allocate the participants into intervention or placebo. The participants will receive a sequentially-numbered, opaque, sealed envelope (SNOSE) which each sealed envelope is given a sequential number according to the order of recruitment and it contains the randomization code. Pharmacists are responsible for the distribution of the SNOSE and intervention products.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Child Health Department of Mohammad Hoesin Hospital

Model Details: It is a double-blind randomized controlled clinical trial to identify the effects of Striatin supplementation on weight, acute inflammation markers, and microbiota profiles of SAM children.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 28, 2025
• Study Start: May 20, 2025
• Primary Completion: February 25, 2026
• Study Completion: April 16, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)