Digestive DiscomfortNCT06870097
A Study on the Effects of A2 Milk on Gut Beneficial Bacteria Growth and Digestion Improvement
A study testing A2 Milk and A1/A2 Milk in people with Digestive Discomfort, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Discomfort
- What is being tested?
- A2 Milk and A1/A2 Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Feb 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.}
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
About this study
Official title: An 8 Week, Stratified Randomiz Ation , Double Blind , Crossover , Placebo Controlled Trial for the Evaluation of the the Effects of A2 Milk on Gut Beneficial Bacteria Growth, Antioxidant Activity, Digestion, and Inflammation Improvement
The aim of this study is to evaluate the effects of A2 milk on gut beneficial bacteria growth, antioxidant activity , digestion, and inflammation improvement
Read the detailed description
Milk has a high calcium content, and calcium in milk is easily digested and absorbed and has an excellent utilization rate in the body. Milk is rich in lactose, Vitamin D, and peptides that facilitate calcium absorption, and it also contains essential amino acids and bioactive substances that are beneficial to health. Regularly drinking milk has been proven to improve insulin sensitivity, blood pressure, and serum lipid concentrations. Furthermore, milk is reported to be an effective food for nutritional supplementation and improvement in the diet of Koreans, as it contains a well balanced source of essential amino acids that can be lacking in a rice centric diet, along with quality animal protein, calcium, vitamin B2, and other nutrients. However, this increase in dairy consumption can be associated with an increased risk for certain disorders, including digestive disorders.
The actual prevalence of lactose intolerance is unclear in Korea, and reports have ranged from 39.1% to 84.1%. In 2010, it was reported that in most individuals who believed they had lactose intolerance, no evidence of problems with lactose absorption could be found, and thus, gastrointestinal symptoms were unlikely to be associated with lactose. Alternatively, A1 β-Casein and β-Casomorphin-7 (BCM-7) has emerged as a major area for research in relation to digestive discomfort following milk consumption.
Milk is composed of 80% Casein protein and 20% whey. Among Casein proteins, β-Casein can be divided into the A1 type comprised of A1, B, C, F, and G, and the A2 type with A2, A3, D, E, H, I, and J variants. A1 and A2 type β-Casein proteins differ in their 67th amino acid, with A1 containing Histidine and B2 with Proline.
The other remaining variants are only found in low levels or not found in European cattle. Furthermore, BCM-7, which is produced when enzymatic cleavage at the histidine position occurs in A1 β-Casein, has been associated with digestive discomfort. Additionally, milk containing A1 β-Casein has been linked to type 1 diabetes and heart disease. Nevertheless, the majority of dairy cattle in dairy industries continue to produce milk containing A1 β-Casein.
Animal tests have shown that milk with A1 β-Casein takes longer to transit through the digestive tract compared to A2 β-Casein containing milk. In addition, a clinical trial reported that the Bristol stool scores in participants who consumed A1 β-Casein milk were higher than those in A2 β-Casein milk. Another clinical trial announced that A2 β-Casein milk alleviated gastrointestinal symptoms of milk hypersensitivity. In addition, there are reports that blood GSH levels, intestinal short chain fatty acids (Acetic acid, butanoic acid), and intestinal beneficial bacteria (Bifidobacterium genus) content are increased.
Therefore, this study aims to evaluate the effects of A2 milk on gut beneficial bacteria growth, antioxidant activity , digestion, and inflammation improvement compared to a control (A1/A2 milk) in individuals who experience discomfort after consuming milk.
- Conditions
- Digestive Discomfort
- Being tested
- A2 Milk, A1/A2 Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A2 MilkOther
Cow's milk that contains only A2 β-Casein
A1/A2 MilkOther
Cow's milk that contains both A1 β-Casein and A2 β-Casein
| Study group | Role | What they receive |
|---|---|---|
| A2 Milk | Active comparator | A2 milk, 275 mL, twice daily after meal (550 mL/day) Receives: Other: A2 Milk |
| A1/A2 milk | Placebo comparator | A1/A2 milk, 275 mL, twice daily after meal (550 mL/day) Receives: Other: A1/A2 Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale (GSRS) Total Score
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.
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Secondary outcomes (16)
Digestive Discomfort Symptom Survey
Participants rate 7 items (abdominal bloating, abdominal pain, borborygmus , fecal urgency, flatulence, diarrhea, nausea) on a numeral rating scale of 0 (Never) to 10 (Very Severe).
Measured: Surveys given on Screening(week -2), Visit 3(week 2) to recorded once a day; Retrieved on Visit 2(week 0), Visit 4(week 4) to recorded twice a day within 30 minutes to 3 hours after consuming the test food;
Visual analogue scale Irritable Bowel Syndrome (VAS-IBS)
The scale of symptoms felt by 7 items {abdominal symptoms (abdominal pain, diarrhea, constipation, abdominal bloating or flatulence , nausea or vomiting) and health and daily items} is displayed on a 100 mm straight line from 0 mm (very good) to 100 mm (very severe).
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : Glutathione (GSH)
Serum levels of GSH measured in ug/mL
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : 8-Oxo-2'-deoxyguanosine (8-OxodG)
Serum levels of 8-OxodG measured in ng/mL
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : 5-hydroxymethyl-deoxyuridine (5-OHmdU)
Serum levels of 5-OHmdU measured in ng/mL
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : High Sensitive C-reactive protein (hs-CRP)
Serum levels of hs-CRP measured in mg/dL
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood marker : Interleukin-4 (IL-4)
Serum levels of IL-4 measured in pg/mL.
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood marker : Interleukin-6 (IL-6)
Serum levels of IL-6 measured in pg/mL
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : Tumor necrosis factor-α (TNF-α)
Serum levels of TNF-α measured in pg/mL.
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : Dipeptidyl Peptidase-4 (DPP-IV)
Serum levels of DPP-IV measured in ng/mL.
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : β-casomorphin-7 (BCM-7)
Serum levels of BCM-7 measured in ug/mL.
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : β casomorphin-10 (BCM-10)
Serum levels of BCM-10 measured in ug/mL.
Measured: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Stool marker : Short chain Fatty Acid (SCFA)
SCFA in stool measured in mg/g.
Measured: Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Stool marker : Calprotectin
Calprotectin in stool measured in mg/kg.
Measured: Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Stool marker : Microbiome
Gut microbiome composition (abundance, %) will be measured in stool via 16S ribosomal ribonucleic acid (rRNA)
Measured: Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Bowel Frequency and Form
Participants record daily bowel frequency and form. The Bristol Stool Scale will be used to measure stool consistency with type 1 (Separate hard lumps, like nuts hard to pass), type 2 (Sausage shaped but lumpy), type 3 (Like a sausage but with cracks on its surface), type 4 (Like a sausage or snake, smooth and soft), type 5 (Soft blobs with clear cut edges passed easily), type 6 (Fluffy pieces with ragged edges, a mushy stool), and type 7 (watery, no solid pieces, entirely liquid).
Measured: Journal provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4) to record daily; Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start26 Feb 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive DiscomfortStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870097
- Sponsor's protocol ID
- B-2412-943-002
- Status last verified
- Apr 2026
- First submitted
- 28 Feb 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Week, Stratified Randomiz Ation , Double Blind , Crossover , Placebo Controlled Trial for the Evaluation of the the Effects of A2 Milk on Gut Beneficial Bacteria Growth, Antioxidant Activity, Digestion, and Inflammation Improvement
- ClinicalTrials.gov ID
- NCT06870097
- Acronym / sponsor ID
- B-2412-943-002
- Conditions
- Digestive Discomfort
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effects of A2 milk on gut beneficial bacteria growth, antioxidant activity , digestion, and inflammation improvement
Detailed description
Milk has a high calcium content, and calcium in milk is easily digested and absorbed and has an excellent utilization rate in the body. Milk is rich in lactose, Vitamin D, and peptides that facilitate calcium absorption, and it also contains essential amino acids and bioactive substances that are beneficial to health. Regularly drinking milk has been proven to improve insulin sensitivity, blood pressure, and serum lipid concentrations. Furthermore, milk is reported to be an effective food for nutritional supplementation and improvement in the diet of Koreans, as it contains a well balanced source of essential amino acids that can be lacking in a rice centric diet, along with quality animal protein, calcium, vitamin B2, and other nutrients. However, this increase in dairy consumption can be associated with an increased risk for certain disorders, including digestive disorders.
The actual prevalence of lactose intolerance is unclear in Korea, and reports have ranged from 39.1% to 84.1%. In 2010, it was reported that in most individuals who believed they had lactose intolerance, no evidence of problems with lactose absorption could be found, and thus, gastrointestinal symptoms were unlikely to be associated with lactose. Alternatively, A1 β-Casein and β-Casomorphin-7 (BCM-7) has emerged as a major area for research in relation to digestive discomfort following milk consumption.
Milk is composed of 80% Casein protein and 20% whey. Among Casein proteins, β-Casein can be divided into the A1 type comprised of A1, B, C, F, and G, and the A2 type with A2, A3, D, E, H, I, and J variants. A1 and A2 type β-Casein proteins differ in their 67th amino acid, with A1 containing Histidine and B2 with Proline.
The other remaining variants are only found in low levels or not found in European cattle. Furthermore, BCM-7, which is produced when enzymatic cleavage at the histidine position occurs in A1 β-Casein, has been associated with digestive discomfort. Additionally, milk containing A1 β-Casein has been linked to type 1 diabetes and heart disease. Nevertheless, the majority of dairy cattle in dairy industries continue to produce milk containing A1 β-Casein.
Animal tests have shown that milk with A1 β-Casein takes longer to transit through the digestive tract compared to A2 β-Casein containing milk. In addition, a clinical trial reported that the Bristol stool scores in participants who consumed A1 β-Casein milk were higher than those in A2 β-Casein milk. Another clinical trial announced that A2 β-Casein milk alleviated gastrointestinal symptoms of milk hypersensitivity. In addition, there are reports that blood GSH levels, intestinal short chain fatty acids (Acetic acid, butanoic acid), and intestinal beneficial bacteria (Bifidobacterium genus) content are increased.
Therefore, this study aims to evaluate the effects of A2 milk on gut beneficial bacteria growth, antioxidant activity , digestion, and inflammation improvement compared to a control (A1/A2 milk) in individuals who experience discomfort after consuming milk.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A2 Milk | Active comparator | Other: A2 MilkA2 milk, 275 mL, twice daily after meal (550 mL/day) |
| A1/A2 milk | Placebo comparator | Other: A1/A2 MilkA1/A2 milk, 275 mL, twice daily after meal (550 mL/day) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A2 MilkCow's milk that contains only A2 β-Casein | Other | A2 Milk |
| A1/A2 MilkCow's milk that contains both A1 β-Casein and A2 β-Casein | Other | A1/A2 milk |
Primary outcome
Gastrointestinal Symptom Rating Scale (GSRS) Total Score
Time frame: 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.
16 secondary outcomes
Digestive Discomfort Symptom Survey
Time frame: Surveys given on Screening(week -2), Visit 3(week 2) to recorded once a day; Retrieved on Visit 2(week 0), Visit 4(week 4) to recorded twice a day within 30 minutes to 3 hours after consuming the test food;
Visual analogue scale Irritable Bowel Syndrome (VAS-IBS)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : Glutathione (GSH)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : 8-Oxo-2'-deoxyguanosine (8-OxodG)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : 5-hydroxymethyl-deoxyuridine (5-OHmdU)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : High Sensitive C-reactive protein (hs-CRP)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood marker : Interleukin-4 (IL-4)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood marker : Interleukin-6 (IL-6)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : Tumor necrosis factor-α (TNF-α)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : Dipeptidyl Peptidase-4 (DPP-IV)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : β-casomorphin-7 (BCM-7)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Blood Marker : β casomorphin-10 (BCM-10)
Time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Stool marker : Short chain Fatty Acid (SCFA)
Time frame: Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Stool marker : Calprotectin
Time frame: Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Stool marker : Microbiome
Time frame: Stool collection kit provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4); Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Bowel Frequency and Form
Time frame: Journal provided on Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4) to record daily; Retrieved on Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayoung Kim, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A2 Milk and A1/A2 Milk in people with Digestive Discomfort, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Symptom Rating Scale (GSRS) Total Score (time frame: Screening (week -2), Visit 2 (week 0), Visit 3 (week 2), Visit 4 (week 4), Visit 5 (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.