CompletedPhase 4

Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People

600 participantsStarted 2016-01

Plain-language summary

This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein proteins on the gastrointestinal symptoms for the health people who self-reported to be lactose intolerant.

Who can participate

Age range

20 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 20\~50 years old male or female subjects; * Non-regular milk drinker with self-reported intolerance to commercial milk; * Suffered from mild to moderate digestive discomfort after milk consumption; * Have normal electrocardiograms (ECG) and blood pressure during quiet respiration; * Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk; * Be willing to comply with all the requirements and procedures of the study; * Agree to sign the informed consent form; * Agree not to enroll in another interventional clinical research study while participating in this study; * Fully understand the nature, objective, benefit and the potential risks and side effects of the study. Exclusion Criteria: * Female on pregnant or feeding； * Have known dairy allergy; * Have severe response to milk intolerance; * Have history of faecal impaction; * Trying to lose weight by following a diet or exercise regimen designed for weight loss, or taking any drug influencing appetite and any drug for weight loss for the last three months ; * Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening; * Currently taking medicines for cardiovascular or metabolic disease; * Have history of or be diagnosed of any of the following diseases that may affect the study results: gastrointestinal disorders, hepatopathy, nephropathy, endocrine disease, blood disorders, respiratory a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastrointestinal Symptom VAS scores at 3 hours

Timeframe: Three hours after product intervention at each of Visit 1 and Visit 2

Trial details

NCT IDNCT02878876

Sponsora2 Milk Company Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03

View on ClinicalTrials.gov More Lactose Intolerance trials

Who can participate

Age range

20 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.