Clinical Trials in South Korea / NCT06252636
Active, not recruiting
Not applicable
Evaluation of the Efficacy and Safety of A2 Milk on Digestion
NCT06252636 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Digestive Discomfort
Investigational drug(s) / intervention(s)
A2 MilkA1/A2 Milk
A2 Milk: Cow's milk that contains only A2 β-Casein.
A1/A2 Milk: Cow's milk that contains both A1 β-Casein and A2 β-Casein.
Study summary
The aim of this study is to evaluate the efficacy and safety of A2 milk versus a control (A1/A2 milk) in individuals with digestive discomfort following milk consumption.
Eligibility
Inclusion Criteria:
1. Between 20 to 70 years of age
2. Participants who are experiencing digestive symptoms (bloating, gas, heaviness, abdominal pain, gurgling stomach, belching, bowel urgency) following milk consumption on Visit 1 with each score on the digestive discomfort symptom survey being 2 points or less. (Individuals who have indicated 0 in all symptoms or 3 in at least one symptom will be excluded.)
3. Those who have agreed to participate and given written consent through the Informed Consent Form prior to the study
Exclusion Criteria:
1. Currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal and urinary, neurological, musculoskeletal, mental, infectious, metabolic diseases, and malignancies
2. Diagnosed with or has a history of gastrointestinal diseases (irritable bowel syndrome, colitis, ulcerative colitis, abdominal diseases etc.), or has undergone gastrointestinal surgery
3. Individuals with severe lactose intolerance
4. History of bowel obstruction
5. Alcohol addiction or substance abuse
6. Hospitalized within the last 3 months of Visit 1
7. Has taken medication affecting body weight {anti-obesity drugs (appetite suppressants, fat absorption inhibitors, Glucagon-like peptide-1 (GLP-1) receptor agonists etc.), psychiatric drugs such as antidepressants and antipsychotics, diuretics, contraceptives, steroids, female hormones, thyroid hormones} within the last 3 months of Visit 1
8. Has taken immunosuppressive drugs or anti-inflammatory drugs within the last month (30 days) of Visit 1
9. Administered antibiotics or laxatives within the last 2 weeks of Visit 2
10. Has taken prokinetics (Serotonin type 4 (5-HT4) Agonist, D2 Antagonists, Cholinergic Agonists etc.), laxatives {fiber supplements (Psyllium, Methylcellulose etc.), stool softeners, osmotic laxatives (Sorbitol, Lactulose etc.), stimulant laxatives (Bisacodyl, Anthraquinone etc.)}
11. Pregnant, breastfeeding, or planning to become pregnant during the study period
12. Allergic to dairy products
13. Participated in another interventional clinical trial (including human trials) within the last 3 months of Visit 1, or planning to participate in another interventional clinical trial (including human trials) after the start of this study
14. Individuals deemed inappropriate for the study by the investigator
Primary outcome measure(s)
- Gastrointestinal Symptom Rating Scale (GSRS) Total Score — Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Evaluated through the Gastrointestinal Symptom Rating Scale (GSRS) which uses a 4-point Likert-type scale from 0 (no symptoms or normal) to 3 (severe symptoms) to rate 15 symptom items including both upper and lower abdominal symptoms. Participants will be given the GSRS to complete.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | South Korea |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06252636 on ClinicalTrials.gov ↗ ← All trials in South Korea