Clinical trial NCT06957717: Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls
Official title: Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls in Yogyakarta, Indonesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: Kefir
Short Chain Fatty Acid
Hemoglobin
Ferritin
Iron Deficiency Anemia
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Its research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta, as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment
Primary purpose: TREATMENT

Brief summary: Introduction: The prevalence of anemia among adolescent girls in Indonesia is still quite high. According to the Indonesian Health Survey (IHS) in 2023, it was 18% and is still a national problem. Long-term supplementation of blood supplement tablets (TTD) as an effort made by the government to prevent/overcome anemia has caused side effects, namely dysbiosis by pathogenic bacteria. Giving cow's milk kefir containing various probiotics can overcome the side effects of supplementation, and its metabolites accelerate iron absorption so that iron status in the blood increases and ultimately restores anemia in adolescent girls. Method: It's research is an experimental study, with a Randomized Controlled Trial (RCT) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at SMKN 1, 2, and 3 Kasihan, Bantul Regency, Yogyakarta as many as 80 students. Subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and TTD 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and TTD 1 grain/week. The duration of administration was 2 months. The study outcomes were Short Chain Fatty Acid (SCFA) levels in feces by Gas Chromatography-Mass Spectrometry (GC-MS) method, hemoglobin by Hematology Analyser method, and serum ferritin by Ferritin ELISA measured at the beginning and end of the study. Statistical analysis included univariate, bivariate, and multivariate analysis. Clinical analysis was also conducted to estimate the effect size of the treatment

Detailed description: This protocol represents the only doctoral research dissertation proposal I will undertake as part of my dissertation, which does not exist.

Eligibility criteria: Inclusion Criteria:

* Adolescent girls aged 15-18 years
* Have a mild and moderate degree of anemia (Hb 8-11.9 g/dl)
* Have a normal menstrual cycle and duration

Exclusion Criteria:

* Suffering from thalassemia, hemosiderosis, blood cancer, and malaria, based on the doctor's diagnosis in the last 3 months
* Taking supplements other than TTD
* Taking antibiotics in the last 3 months
* Suffering from lactose intolerance through interviews

Primary outcomes:
measure: Short Chain Fatty Acid
timeFrame: 2 months after intervention
measure: hemoglobin
timeFrame: 2 months after intervention
measure: Ferritin
timeFrame: 2 months after intervention
Secondary outcomes:
measure: Nutrient intake
timeFrame: 2 months after intervention
measure: Nutritional status of adolescent girls (body mass index / age)
timeFrame: 2 months after intervention
measure: Menstrual cycle and duration of adolescent girls
timeFrame: 2 months after intervention
measure: Diarrhea
timeFrame: 2 months after intervention
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Gadjah Mada University
Study officials:
References: