Clinical Trials in South Korea / NCT06870097
Active, not recruiting
Not applicable
A Study on the Effects of A2 Milk on Gut Beneficial Bacteria Growth and Digestion Improvement
NCT06870097 · 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 effects of A2 milk on gut beneficial bacteria growth, antioxidant activity , digestion, and inflammation improvement
Eligibility
Inclusion Criteria:
* Between 19 to 65 years of age
* Participants who are experiencing digestive symptoms abdominal bloating, abdominal pain, borborygmus, fecal urgency, flatulence, diarrhea, nausea) following milk consumption on Visit 1 with a total score on the digestive discomfort symptom survey being 7 point or more for the following 5 items: abdominal pain, borborygmus , flatulence, diarrhea, nausea. (Individuals who have indicated scored 7 or more on any one item in the symptom will be excluded)
* Those who have agreed to participate and given written consent through the Informed Consent Form prior to the study
Exclusion Criteria:
* Currently undergoing treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal an durinary, neurological, musculoskeletal, mental, infectious, metabolic diseases, and malignancies
* Diagnosed with or has a history of gastrointestinal diseases (irritable bowel syndrome, colitis, ulcerative colitis, abdominal diseases etc.), or has undergone gastrointestinal surgery
* History of bowel obstruction
* Hospitalized within the last 3 months of Visit 1
* Has taken the following drugs or foods within 3 months of visit 1
① Drugs that affect body weight {obesity drugs (appetite suppressants, fat absorption inhibitors, Glucagon-like peptide-1 (GLP-1) recept or agonists etc.) etc.), diabetes drugs, etc.}
② Psychiatric drugs such as antidepressants and antipsychotics
③ Diuretics
④ Systemic steroid preparations and hormonal preparations (including oral contraceptives and thyroid hormone preparations
* Has taken immunosuppressive drugs or anti inflammatory drugs within the last month (30 days) of Visit 1
* Administered systemic antibiotics, systemic antibacterial agents, colonics, bowel cleansers, probiotics, prebiotics, antioxidant related health functional foods (Coenzyme Q10, red ginseng, etc.), and glutathione containing products within 2 weeks of visit 1 (however, vitamin preparations can be used together if taken without changing dosage or medication for more than 3 months
* Has taken prokinetics (Serotonin type 4 (5-HT4) Agonist, D2 Antagonists, Cholinergic Agonists etc.), laxatives {fiber supplements (Psyllium, Methylce llulose etc.), stool softeners, osmotic laxatives (Sorbitol, Lactulose etc.), stimulant laxatives (Bisacodyl , Anthraquinone etc.)} within 1 week of visit 1
* History of alcohol abuse or who chronically consume alcohol\*
\* Drinking alcohol equivalent to an average of 40 g or more per day (280 g/week) for men and more than 20 g of alcohol per day (140 g/we ek) for women.
* Pregnant, breastfeeding, or planning to become pregnant during the study period
* 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
* Allergic to dairy products (bloody stool, muscle/joint pain, headache, dizziness, coma, short term memory impairment, oral ulcer, cardiac arrhythmia, sore throat, increased frequency of urination, acne, depression)
* Individuals deemed inappropriate for the study by the investigator
Primary outcome measure(s)
- Gastrointestinal Symptom Rating Scale (GSRS) Total Score — Screening (week -2), 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 7 point Likert type scale from 1 (no symptoms or normal) to 7(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 NCT06870097 on ClinicalTrials.gov ↗ ← All trials in South Korea