|Inclusion criteria||Exclusion criteria|
• Healthy volunteers ≥ 30 and ≤ 75 years of age.|
• Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2.
• Lactose Challenge Test 6-hour Symptom Score (SSC) >10
• Judged by the Investigator to be in good health.
• Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
• Agree not to initiate any new exercise or diet programs during the entire study period.
• Agree to halt consumption of probiotic products or lactose digestion aids two weeks prior to study.
• Agree not to change their current diet or exercise program during the entire study period.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
• Subjects with congenital lactose deficiency.|
• Any significant GI condition that would potentially interfere with the evaluation of the study product including but not limited to:
o Inflammatory bowel disease (Ulcerative Colitis or Crohn’s Disease)
o Frequent diarrhea
o Surgery for weight loss (e.g., gastric bypass or lap band)
o History of gastrointestinal perforation.
o History of gastroparesis.
• Recent (within two weeks of Visit 1) episode of acute gastrointestinal illness such as nausea, vomiting, or diarrhea.
• Consumption of antibiotics and/or laxatives within the three months prior to the study
• History of immunocompromise or auto-immune disorder.
• Use of any immunosuppressive drugs in the last 12 months (including steroids or biologics)
• Active infection requiring antibiotics, anti-viral medication, or hospitalization
• Subjects with known sensitivities to the ingredients in the study product
• Subjects who are pregnant or lactating
• Subjects with a history of seizure
• Subjects on anticoagulation therapy
• Subjects with known alcohol abuse or recreational drug abuse
• Subjects with brain and/or spinal cord injury
• Untreated or unstable hypothyroidism
• Subjects with any cancer in the last 5 years (except non-melanoma skin cancer)
• Surgery within the last 6 months
• Any clinically significant burn within the last 6 months
• Abnormal physical examination
• Subjects unable to understand or follow the study protocol