Comparing the Inflammation, Maldigestion and Symptoms Due to Commercial Milk and A2 Milk

Launched by PURDUE UNIVERSITY · Dec 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how two types of cow's milk—A1 milk and A2 milk—affect people who are lactose intolerant. Researchers want to see if drinking A1 milk, which contains a specific protein that may cause more inflammation and symptoms, leads to more discomfort compared to drinking A2 milk, which does not have this protein. Participants will be randomly assigned to drink either A1 or A2 milk to compare the effects on their symptoms and inflammation in their bodies.

To participate, you should be between 18 and 65 years old and have experienced issues with dairy for at least a month. You'll need to be willing to follow the study rules, like avoiding other treatments for dairy intolerance during the trial. Participants can expect to attend several study visits, where they will drink one type of milk and report their experiences. It's important to note that people with certain medical conditions or those who are pregnant or breastfeeding cannot join the study. If you're interested and meet the criteria, this study could help improve our understanding of how different types of milk affect lactose intolerance.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Ability/desire to provide informed consent
• • Aged 18 to 65 years of age inclusive at screening
• • Current or recent history of intolerance to or avoidance of dairy of at least one month duration (by self-report and self-reported symptoms).
• • Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid® Dietary Supplements) during study involvement
• • Willing to return for all study visits and complete all study related procedures
• • Able to understand and provide written informed consent in English
• Exclusion Criteria:
• • • Allergic to milk
• • Currently pregnant
• • Currently lactating
• • Cigarette smoking or other use of tobacco or nicotine containing products within 3 months of screening
• • Diagnosed with any of the following disorders known to be associated with abnormal gastrointestinal motility such as; Gastroparesis, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism
• • History of surgery that alters the normal function of the gastrointestinal tract including, but not limited to: gastrointestinal bypass surgery, bariatric surgery, gastric banding, vagotomy, fundoplication, pyloroplasty \[Note: history of uncomplicated abdominal surgeries such as removal of an appendix more than 12 months prior to screening will not be excluded\]
• • Past or present : Organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, chronic constipation, diverticulosis, inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), small intestine bacterial overgrowth syndrome (SIBO), gastroparesis, gastro-esophageal reflux disease (GERD), Irritable Bowel Syndrome (IBS) or any other medical condition with symptoms that could confound collection of adverse events.
• • Active ulcers, or history of severe ulcers
• • Diabetes mellitus (type 1 and type 2)
• • Congestive Heart Failure (CHF)
• • Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
• • Height: ___ Weight: ___ BMI: ___
• • o Weighing \<16.5 kg and BMI \> 35 kg/m2
• • Recent bowel preparation for endoscopic or radiologic investigation within four weeks of screening (e.g., colonoscopy prep)
• • Use of concurrent therapy(ies) or other products (e.g., laxatives, stool softeners, Pepto Bismol®, Lactaid® Dietary Supplements) used for symptoms of dairy intolerance within 7 days of screening
• • Chronic antacid and/or PPI use
• • Recent use of systemic antibiotics defined as use within 30 days prior to screening
• • Recent high colonic enema, defined as use within 30 days prior to screening
• • Any concurrent disease or symptoms which may interfere with the assessment of the cardinal
• • symptoms of dairy intolerance (i.e., gas, diarrhea, bloating, cramps, stomach pain)
• • History of ethanol (alcohol) and/or drug abuse in the past 12 months
• • Currently undergoing chemotherapy
• • Use of any investigational drug or participation in any investigational study within 30 days prior to screening
• • Prior enrollment in this study
• • Any other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance