Clinical trial NCT06933862: Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District
Official title: Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnourished Children
Keywords: snakehead fish extract
malnourished children
Calprotectin
striatin
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Dexa Medica Group
First posted: 2025-04-18
Enrollment: 122
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study participants were divided into 2 groups namely group A which received snakehead fish extract or inbumin forte sachet and group B which received a placebo. The study was conducted randomly and double blinded.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Z-score (weight for age)
timeFrame: three months after intervention
measure: z-score (height for age)
timeFrame: three months after intervention
Secondary outcomes:
measure: Concentrations of fecal calprotectin
timeFrame: From enrollment to the end of treatment at 3 months
measure: Concentrations of Alpha 1 Anti Trypsin (AAT) levels in stool
timeFrame: From enrollment to the end of treatment at 3 months
measure: Concentrations of amino acid in blood samples
timeFrame: From enrollment to the end of treatment at 3 months
measure: Complete hematological profiles
timeFrame: From enrollment to the end of treatment at 3 months
measure: Iron status levels
timeFrame: From enrollment to the end of treatment at 3 months
measure: Intestinal microbiota profiles
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
Locations:
city: South Bangka or Toboali
country: Indonesia
facility: Indonesian territories
state: Bangka Belitung
city: Central Jakarta
country: Indonesia
facility: IMERI Faculty of Medicine Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Taniawati Supali
role: STUDY_CHAIR
References:
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citation: Potential effect of Striatin (DLBS0333), a bioactive protein fraction isolated from Channa striata for wound treatment
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