Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

Inclusion Criteria:

- Patient is 18-75 years of age, inclusive, at screening;

- Intolerance to milk and other dairy products;

- Patient agrees to refrain from all other treatments and products used for lactose
intolerance, to follow diet modifications required during periods of the study that
include abstinence from all dairy in some periods and consuming dairy in other
periods;

- Patient meets the defined minimum lactose intolerance symptom composite score; and

- Patient has positive Hydrogen Breath Test (HBT) results for lactase deficiency.

Exclusion Criteria:

- Patient has a disorder associated with abnormal gastrointestinal motility such as
gastroparesis (from any cause), amyloidosis, neuromuscular diseases (including
Parkinson's disease), collagen vascular diseases, uremia, or malnutrition;

- Patient has undergone bowel preparation for endoscopic or radiologic investigation
within 4 weeks of Screening (example, colonoscopy preparation);

- Patient has a history of surgery that alters the normal function of the
gastrointestinal tract including, but not limited to: fundoplication, gastrointestinal
bypass surgery, bariatric surgery, gastric banding, colostomy, vagotomy, pyloroplasty,
colectomy or other surgery for Crohn's disease or ulcerative colitis; and

- Patient has received antibiotic treatment, or had a high colonic enema, colonic
irrigation, colonic hydrotherapy, or colonic cleaning within 30 days prior to or
during Screening.