A1 Versus A2® Milk on the Gastrointestinal Physiology, Symptoms and Cognitive Behaviour for the Preschool Children

Last updated: March 10, 2017
Sponsor: a2 Milk Company Ltd.
Overall Status: Completed

Phase

4

Condition

Inflammation

Treatment

N/A

Clinical Study ID

NCT03081845
15-SC-5-A2-002
  • Ages 5-6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a multiple-sites, double-blinded, randomized, controlled, parallel-designed, cross-over study among healthy preschoolers with 5 days consumption of A2 or A1 milk to compare the effects on gut inflammation, gastrointestinal symptoms and behavioral well-being.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non-regular milk drinker;

  • Suffered from mild to moderate milk intolerance;

  • Agree not to take any medication, supplements, nutrition or other dairy productsincluding acidophilus milk;

  • Parent(s) or legal guardian's consent to the study and willing to comply with studyprocedures;

  • Parent(s) or guardian of infant agrees not to enroll infant another clinical studywhile participating in this study;

  • Fully understand the nature, objective, benefit and the potential risks and sideeffects of the study.

Exclusion

Exclusion Criteria:

  • Have known dairy allergy;

  • Suffered from severe milk intolerance;

  • Unable to give written informed consent;

  • Use of antibiotics at the time of screening, or during the past two weeks;

  • Have history of fecal impaction;

  • Trying to lose weight by following a diet or exercise regimen designed for weightloss, or taking any drug influencing appetite and any drug for weight loss for thelast three months;

  • Have participated in similar dairy or probiotics-containing product's clinical trialswithin 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 thestudy results: gastrointestinal disorders, hepatopathy, nephropathy, endocrinedisease, blood disorders, respiratory and cardiovascular diseases;

  • 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;

  • According to investigator's judgment, current frequent users of drugs may affect thegastrointestinal function or immune system.

Study Design

Total Participants: 80
Study Start date:
September 13, 2016
Estimated Completion Date:
January 20, 2017

Study Description

Gut inflammation is reflected by serum C-Reactive Protein (CRP), hemoglobin (HB), interleukin-4 (IL-4), Immunoglobulin G (IgG), Immunoglobulin E (IgE), Immunoglobulin G1 (IgG1), Immunoglobulin G2a (IgG2a), β-Casomorphin-7 (BCM-7), Glutathione, calcium (Ca), iron (Fe) and zinc (Zn) concentration; gastrointestinal (GI) symptoms are measured via Visual Analog Scale (VAS) for gut tolerance, including borborygmus, bloating, break wind, abdominal pain, and diarrhea; behavioral well-being is assessed using Subtle Cognitive Impairment Test (SCIT).

The total duration of study was 24 weeks, including subject enrollment, study intervention, laboratory testing, and providing clinical study report. The cross-over study consisted of 5 days of each product intervention; 10 days of wash-out in phase 1 and phase 2, respectively; and then followed by 6 weeks of statistical analysis and clinical report completion.