Table 1 Inclusion and 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