The A1 Protein Free Vs Conventional milk study in lactose tolerant and lactose intolerant consumers

Exclusion Criteria31

• Medical Conditions
• Individual who is pregnant or planning to become pregnant during the duration of the study.
• Any known or suspected contraindications to A1PF milk or Con milk including allergy to cow’s milk or other related conditions (with the exception of lactose intolerance for Cohort 2).
• Individual self-reports as likely to vomit if they drink approximately 300ml (a glass) of milk. Or reports vomiting following milk challenge at screening.
• Any known or suspected contraindications to blood draws, or is unable to provide a blood sample without significant distress, or has poor peripheral venous access and is unsuitable for cannulation/repeated venipuncture.
• Participant has history or evidence of any clinically significant gastrointestinal condition, including oesophageal reflux, peptic ulcer disease, erosive oesophagitis, frequent (more than once per week) occurrence of heartburn, galactosemia, gastroparesis, amyloidosis, inflammatory bowel disease, malnutrition, gastric ulcers, chronic constipation, celiac disease, gastro-oesophageal reflux disease, or any other related condition that in the opinion of thenvestigator or Medical Monitor might obfuscate the study data (e.g., neuromuscular diseases,
• or diseases effecting gastric motility).
• Participant has a documented medical history of human immunodeficiency virus (HIV), acute
• or chronic hepatitis B or acute or chronic hepatitis C (RNA positive), or a positive test for these at screening.
• Participant has concurrent symptoms that may confound AE collection or assessment of symptoms of dairy intolerance: including diarrhoea, abnormal gas, bloating, cramps, or stomach pain.
• Prior/Concomitant Therapy
• Participant has history of medical interventions associated with altered GI function including: bariatric surgery, gastric bypass, or gastrointestinal endoscopy (within last 6 weeks), or any other related surgical intervention that in the opinion of the Investigator or Medical Monitor might obfuscate study data.
• Participant is concurrently using or recently used (within 14 days of Day 1; 30 days for antibiotics) medications that may confound AE collection or assessment of symptoms of dairy intolerance, including: laxatives, stool softeners, antacids, lactase medications (or lactase fortified foods).
• Participant is concurrently using or recently used (within 14 days of Day 1) any prescription drugs, vaccinations, vitamins or supplements unless in the opinion of the Investigator or Medical Monitor, they will not interfere with the study data or procedures.
• Prior/Concurrent Clinical Study Experience
• Participant has participated in any interventional clinical study or had been treated with any investigational drugs within 28 days or 5 half-lives, whichever was longer.
• Diagnostic Assessments
• Abnormal and clinically significant vital signs, after 5 minutes supine rest, with normal ranges as defined by: Systolic Blood Pressure (BP) 140 mmHg; Diastolic BP 90 mmHg; heart rate 85 beats per minute (BPM); tympanic body temperature 37.7; respiratory rate 25. Abnormal values may be repeated once at the discretion of the Investigator.
• Positive screen for drugs of abuse, or alcohol at the Screening Visit.
• A positive test for human immunodeficiency virus (HIV), hepatitis B or hepatitis C (RNA positive), at screening.
• Any abnormal and clinically significant results from screening blood tests (normal/abnormal defined by local laboratory reference values)
• Other Exclusions
• Participant has consumed milk-containing products within 7 days prior to Day 1 (and until completion of the final follow-up on Day 12). Participant must abstain from dairy (animal) milk- containing foods such as: fresh milk, UHT milk, powdered milk, condensed milk, cheese, cream, yogurt, whey protein, milky coffee and tea, ice cream, butter, ghee, and other related products prepared with milk/dairy products.
• Participant has any dietary restrictions or preferences that may interfere with them taking part in the study including being vegan or being unwilling to abstain from consumption of milk products for the length of the study.
• Participant is unwilling to abstain from alcohol for 48 hours prior to dosing and for the 24 hours prior to screening.
• Participant has donated blood in the 3 months prior to Day 1 or Day 8, or plasma in the two weeks prior to screening, Day 1 or Day 8.
• Participant has any planned surgery during the study duration.
• Participant is an employee, consultant, and/or immediate family member (ie, first degree
• relative, spouse, adoptees, or legal dependents) of the site or Sponsor.
• Any other condition which, at the Investigator’s discretion, is believed may present a safety risk
• or impact the feasibility of the study or the study results.