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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
Phase
Not applicable
Started
2025-02-26
Last updated
2026-04-28

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

Sex
ALL
Min age
19 Years
Max age
65 Years
Healthy volunteers
Accepted
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)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si South Korea

Other trials for the same condition

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