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

NCT ID: NCT06933862

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2026-06-30

Brief Summary

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.

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.

Conditions

Malnourished Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Striatin

Intervention Type: DIETARY_SUPPLEMENT

striation or placebo given for 90 days assigned to striatin

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

placebo

Interventions

Striatin

striation or placebo given for 90 days assigned to striatin

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 17 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dexa Medica Group

INDUSTRY

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Monica Puspa Sari

Head of Laboratory, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taniawati Supali

Role: STUDY_CHAIR

Indonesia University

Locations

Indonesian territories

South Bangka Or Toboali, Bangka–Belitung Islands, Indonesia

IMERI Faculty of Medicine Universitas Indonesia

Central Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Central Contacts

Monica Puspa Sari

Role: CONTACT

monica.puspasari@ukrida.ac.id

+62853-1198-0272

Facility Contacts

Dinas Kesehatan

Role: primary

dinkes@babelprov.go.id

0717-6242141

Role: backup

6285311980272

Monica Puspa Sari, Magister of Biomedic

Role: backup

References

Snakehead Fish (Channa striata) and Its Biochemical Properties for Therapeutics and Health Benefits

Reference Type: BACKGROUND

Potential effect of Striatin (DLBS0333), a bioactive protein fraction isolated from Channa striata for wound treatment

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 9548618 (View on PubMed)

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PMID: 25742018 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Lahav-Ariel L, Caspi M, Nadar-Ponniah PT, Zelikson N, Hofmann I, Hanson KK, Franke WW, Sklan EH, Avraham KB, Rosin-Arbesfeld R. Striatin is a novel modulator of cell adhesion. FASEB J. 2019 Apr;33(4):4729-4740. doi: 10.1096/fj.201801882R. Epub 2018 Dec 28.

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Other Identifiers

MPuspaSari

Identifier Type: -

Identifier Source: org_study_id