Effect of Cow's Milk Kefir on Short Chain Fatty Acid (SCFA), Haemoglobin, and Ferritin Levels of Anemic Adolescent Girls

Lusyana Gloria Doloksaribu

Status: Not yet enrolling

Conditions: Iron Deficiency Anemia

Treatments: Combination Product: cow's milk kefir; Combination Product: pasteurized cow's milk

Study type: Interventional

Funder types: Other

Identifiers

NCT06957717

GadjahMada

Details and patient eligibility

About

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

Full description

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

Enrollment: 80 estimated patients

Sex: Female

Ages: 15 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

intervention group

Active Comparator group

Description:

Fresh cow's milk drink pasteurized at 72 °C, and fermented by kefir grain (5%) for 24 hours at 25 °C, then filtered to produce cow's milk kefir, and stored at 4 °C for 24 hours before drinking, given as 1 bottle/day of 120 ml + 10% liquid sugar for 2 months.

Treatment:

Combination Product: cow's milk kefir

control group

Placebo Comparator group

Description:

Fresh cow's milk drink pasteurized at 72 °C, without fermentation, given 1 bottle/day of 132 ml for 2 months

Treatment:

Combination Product: pasteurized cow's milk