Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District (Striatin1)

April 10, 2025 updated by: Monica Puspa Sari, Indonesia University

The goal of this clinical trial is to learn if intervention with channa striata extract or inbumin forte sachet as a food supplement can improve intestinal damage and nutritional status in malnourished children aged 1.5-5 years. The main questions it aims to answer are:

  • Whether there is a change in calprotectin and AAT levels after administration of snakehead fish extract of inbumin forte sachet?
  • Whether there is a difference in changes in nutritional status after administration of snakehead fish extract or inbumin forte sachet? Researchers will compare snakehead fish extract or inbumin forte sachet to a placebo (a look-alike substance that contains no drug) to see if snakehead fish extract or inbumin forte sachet works to treat children malnutrition.

Participants will take snakehead fish extract or inbumin forte sachet or placebo every day for 3 months. Researchers will visit study participants every month to check their weight and height and monitor vitamin administration through photos, notes and videos sent every day and records complaints or symptoms that may arise and at the end of 3 months, researchers will collect stool and blood samples and check nutritional status.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study participants were malnourished children aged 1.5 to 5 years. Data on malnourished children were obtained from the local health department. Based on this data, participants were selected from several sub-districts with the highest malnutrition cases, including Toboali (Rias and Toboali villages), Payung, Air Gegas, and Batu Betumpang sub-districts. After invitations were sent to the participants, they were registered using their family registration card and assigned a queue number or research code. The study plan and research procedures were then explained to the participants. First, anthropometric measurements were conducted including weight and height, with the results entered into the WHO Anthro calculator (-3 SD to <-2 SD). Baseline blood samples were collected, and labeled stool sample bottles were distributed. Fresh stool samples were collected the next day at a designated location. A 100 mg portion of each stool sample was transferred into a 1.5 ml Eppendorf tube and stored in a -20°C freezer. Each sample was divided into two tubes: one for gut microbiota analysis and the other for AAT and calprotectin testing using ELISA. Additionally, the Kato-Katz method was used to examine fresh stool samples for helminth infections. Following stool sample collection, participants were given albendazole at the appropriate dosage. Blood sample analysis included a complete blood count, amino acid testing using filter paper, serum ferritin using mini Vidas immunology analyzer, serum iron, total iron-binding capacity (TIBC) using Vitros chemistry analyzer and serum retinol levels using ELISA. Two weeks after albendazole administration, stool samples were re-examined using Kato-Katz method to confirm the absence of helminth infection. Then, participants were randomly assigned in a double-blind manner into two groups: one receiving snakehead fish extract (Inbumin Forte) and the other receiving a placebo. Based on sample size calculations, a minimum of 98 participants was required, and accounting for a 20% dropout rate, the total sample size was set at 122 children. Data processing was conducted using SPSS. A univariate analysis was performed to determine data distribution on ratio, nominal, and ordinal scales. Categorical data (nominal and ordinal) were presented as frequencies and percentages. Normality tests for numerical data were conducted using the Kolmogorov-Smirnov test, with a normal distribution determined if p > 0.05. Normally distributed data were presented as mean and standard deviation, while non-normally distributed data were shown as median and range (minimum-maximum).

Bivariate analysis was conducted to determine whether there were significant differences in nutritional status, macronutrient and micronutrient levels, inflammatory markers, intestinal permeability, and gut microbiota between children receiving striatin protein supplementation and those receiving a placebo. A paired t-test was used if the data were normally distributed to analyze mean differences between the two groups. If the data were not normally distributed, a chi-square test or Mann-Whitney test was applied. The effect of striatin protein intake on the studied variables was assessed using linear regression analysis. The hypothesis test results were interpreted at a 95% confidence level (α = 0.05), with the null hypothesis (H₀) being rejected if p < 0.05.

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Indonesia
    • Bangka Belitung
      • South Bangka or Toboali, Bangka Belitung, Indonesia, 33783
        • Indonesian territories
        • Contact:
        • Contact:
          • Phone Number: 6285311980272
        • Contact:
          • Monica Puspa Sari, Magister of Biomedic
    • DKI Jakarta
      • Central Jakarta, DKI Jakarta, Indonesia, 10430
        • IMERI Faculty of Medicine Universitas Indonesia

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:

  • Malnourished children aged 1.5-5 years (-3SD to < -2 SD)
  • Parents or guardians are willing to participate in the study
  • Parents or guardians can read and fill out the questionnaire

Exclusion Criteria:

  • Children with chronic diseases such as tuberculosis, congenital heart disease, diabetes, cancer, epilepsy, HIV Aids, sickle cell anemia, and mental illness.
  • Children with history of snakehead fish allergy
  • Children with physical disabilities that complicate data collection

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Malnourished: Striatin
Striatin or inbumin forte is given in the form of a 5 g dose of powder and 250 mg of curmicin. Striation or inbumin forte powder dissolved in 30 ml of drinking water and given one sachet per day, taken in the morning and evening after meals and given for 90 days
Dietary supplement: Striatin
striation or placebo given for 90 days assigned to striatin
Placebo Comparator: Malnourished: Placebo
placebo of striatin containing 4.89 g of mannitol was given in powder form and dissolved in 30 ml of drinking water. Placebo of striatin was given one sachet per day, taken in the morning and evening after meals and given for 90 days.
Dietary supplement: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Z-score (weight for age)
Time Frame: three months after intervention
Z-score according to WHO antropometry that will be collected is based on weight for age. Body Weight in kg will be measured using a SECA brand weight scale. The differences between placebo and Inbumin Forte will be analysed after 3 months of treatment.
three months after intervention
z-score (height for age)
Time Frame: three months after intervention
Z-score according to WHO antropometry that will be collected is based on height for age. Height in cm will be using SECA brand height scale. The differences between placebo and Inbumin Forte will be analysed after 3 months of treatment.
three months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentrations of fecal calprotectin
Time Frame: From enrollment to the end of treatment at 3 months
Calprotectin in stool samples were examined using ELISA (in mcg/g). The differences between placebo and Inbumin will be analysed at the end of 3 months.
From enrollment to the end of treatment at 3 months
Concentrations of Alpha 1 Anti Trypsin (AAT) levels in stool
Time Frame: From enrollment to the end of treatment at 3 months
Alpha 1 Anti Trypsin (AAT) levels in stool samples were examined using ELISA (mcg/g). The differences in the concentrations of AAT levels between placebo and Inbumin Forte groups will be analysed after 3 months of treatment.
From enrollment to the end of treatment at 3 months
Concentrations of amino acid in blood samples
Time Frame: From enrollment to the end of treatment at 3 months
Amino acids levels (µmol/l) in blood samples were examined using LC-MSMS. The differences of amino acid levels between placebo and Inbumin Forte will be analysed at the end of 3 months
From enrollment to the end of treatment at 3 months
Complete hematological profiles
Time Frame: From enrollment to the end of treatment at 3 months
Complete hematological profiles in blood samples were examined using sysmex analyzer. The differences between placebo and Inbumin will be analysed at the end of 3 months.Time Frame: From enrollment to the end of treatment at 3 months
From enrollment to the end of treatment at 3 months
Iron status levels
Time Frame: From enrollment to the end of treatment at 3 months
serum ferritin (ng/ml) were examined using mini vidas immunology analyzer, serum iron (µg/dL), total iron binding capacity (µg/dL) were examined using Vitros Chemistry analyzer. The differences between placebo and Inbumin will be analysed at the end of 3 months.Time Frame: From enrollment to the end of treatment at 3 months
From enrollment to the end of treatment at 3 months
Intestinal microbiota profiles
Time Frame: From enrollment to the end of treatment at 3 months
Intestinal microbiota were examined using PCR technique. The differences between placebo and Inbumin will be analysed at the end of 3 months.Time Frame: From enrollment to the end of treatment at 3 months
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

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

Sponsor

Indonesia University

Collaborators

Dexa Medica Group

Investigators

  • Study Chair: Taniawati Supali, Indonesia University

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

Helpful Links

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 (Estimated)

May 15, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPuspaSari

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

product manufactured in and exported from the U.S.

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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