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Lactose IntolerancePhase 4NCT02878876

Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People

A Phase 4 study testing Oral consumption of milk with sequence A1-A2 and Oral consumption of milk with sequence A2-A1 in people with Lactose Intolerance, run by a2 Milk Company Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Lactose Intolerance
What is being tested?
Oral consumption of milk with sequence A1-A2 and Oral consumption of milk with sequence A2-A1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
No sites listed yet
Study dates
Jan 2016to Mar 2016
Phase
Phase 4
Are there results?
None posted in the registry

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 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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 and cardiovascular diseases;
  • Current or previous alcohol abuser, currently taking or took illicit drugs, substance or OTC prescription drugs in regular frequency which may affect gastrointestinal disorders and study result;
  • Currently suffering from any gastrointestinal disorders or gastrointestinal disease, including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
  • Had hospitalizations within 3 months before screening;
  • Currently drug frequency user of that may affect the gastrointestinal function or immune system. As judged by investigator.

About this study

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.

Read the detailed description

Study sites: Shanghai, Guangzhou, Beijing

Eligible subjects were enrolled in the study and randomized into one of the 2 study arms:

Sequence A1-A2: Oral consumption of milk containing both A1 and A2 type beta casein at Visit 1 and milk containing only A2 type beta casein at Visit 2; Sequence A2-A1: Oral consumption of milk containing only A2 type beta casein at Visit 1 and milk containing both A1 and A2 type beta casein at Visit 2.

Washout period: 2 weeks between Visit 1 and Visit 2

Being tested
Oral consumption of milk with sequence A1-A2, Oral consumption of milk with sequence A2-A1
Medical subject headings
Lactose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral consumption of milk with sequence A1-A2Dietary supplement

    Oral consumption of 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).

  • Oral consumption of milk with sequence A2-A1Dietary supplement

    Oral consumption of 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).

Study groups in NCT02878876
Study groupRoleWhat they receive
Sequence A1-A2ExperimentalDietary Supplement: Oral consumption of milk with sequence A1-A2
Receives: Dietary Supplement: Oral consumption of milk with sequence A1-A2
Sequence A2-A1ExperimentalDietary Supplement: Oral consumption of milk with sequence A2-A1
Receives: Dietary Supplement: Oral consumption of milk with sequence A2-A1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastrointestinal Symptom VAS scores at 3 hours

    Gastrointestinal symptoms were self-measured by study subjects on a scale from 0 (not at all) to 9 (severe) at 3 hours after product consumption at Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with symptom VAS scores at 3-hour as outcome, study product (A1 or A2) and study visit (1 or 2) as fixed effects, and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.

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

Secondary outcomes (4)

  1. The percentage of improvement in gastrointestinal symptoms after drinking A2 versus A1

    The improvement in gastrointestinal symptoms after drinking A2 versus A1 were classified into 4 mutually exclusive categories according to the following definition:

    • No symptom: have no gastrointestinal symptoms after drinking product A2 while having symptoms after drinking product A1.
    • Significant improvement: still have gastrointestinal symptom after drinking product A2, the reduction of symptom scores >3
    • Slight improvement: still have gastrointestinal symptom after drinking product A2, 1<=reduction of symptom scores<=3
    • No difference (not improved or worsen): reduction of symptom scores<=0

    The frequency and percentage in each category of improvement for each single gastrointestinal symptom, as well as that for all symptoms, are summarized.

    Measured: 1 hour and 3 hours after product intervention

  2. Urinary galactose concentration

    Urinary galactose (U-gal) concentration was measured at baseline and 3-hour of each of Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with fixed effects of study product (A1 or A2) and study visit (1 or 2) and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.

    The U-gal measurements over the whole study period (both Visit 1 and Visit 2) for all subjects were also summarized by study product. Product difference was evaluated using one-way ANOVA.

    Measured: baseline and 3 hours after product intervention of each of Visit 1 and Visit 2

  3. Gastrointestinal Symptom VAS scores at 1 hour

    Gastrointestinal symptoms were self-measured by study subjects on a scale from 0 (not at all) to 9 (severe) at 1 hour after product consumption at Visit 1 and Visit 2. Data was analyzed as a repeated measures design using a mixed effects ANOVA with symptom VAS scores at 1-hour as outcome, study product (A1 or A2) and study visit (1 or 2) as fixed effects, and a random subject effect nested within the sequence of study treatment (A1-A2 or A2-A1) , and adjusted for baseline symptom scores. Type III tests of fixed effects were used for testing the effect of study products. Contrast tests were generated to compare means for each product.

    Measured: One hour after product intervention at each of Visit 1 and Visit 2

  4. Change of urinary galactose concentration from baseline at 3 hours <0.27 mmol/L (Yes/No)

    Based on the results of urinary galactose test, subjects were classified as lactose malabsorbers if they had an increase in urinary galactose concentration of <0.27 mmol/L at 3 hours after oral consumption of 15g lactose (corresponding to 300 ml of product A1). And those with an increase in urinary galactose concentration of ≥0.27 mmol/L at 3-hour were classified as lactose absorbers.

    Measured: 3 hours after product intervention of each of Visit 1 and Visit 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

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 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02878876
Sponsor's protocol ID
15-SC-11-A2-004
Status last verified
Aug 2016
First submitted
16 Aug 2016
Last updated
25 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • He M, Sun J, Jiang ZQ, Yang YX. Effects of cow's milk beta-casein variants on symptoms of milk intolerance in Chinese adults: a multicentre, randomised controlled study. Nutr J. 2017 Oct 25;16(1):72. doi: 10.1186/s12937-017-0275-0.

    PubMed 29070042

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral consumption of milk with sequence A1-A2 and Oral consumption of milk with sequence A2-A1 in people with Lactose Intolerance, run by a2 Milk Company Ltd..

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 9 inclusion and 12 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: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 VAS scores at 3 hours (time frame: Three hours after product intervention at each of Visit 1 and Visit 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02878876, which also lists 1 linked publication.

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 25 Aug 2016.

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