Lactose Intolerance
Conditions
Keywords
lactose maldigestion, dairy intolerance, intolerance to milk, intolerance to dairy, milk intolerance, GI disorder, lactose metabolism, GI symptoms after dairy ingestion
Brief summary
This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.
Detailed description
Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming too much lactose or when lactose is added to a previously low-lactose diet. Lactose intolerance is characterized by one or more of the cardinal symptoms that follow the ingestion of lactose-containing foods. These symptoms include; abdominal pain/cramps, bloating, flatulence \[gas\] and diarrhea. As such, most lactose intolerant individuals avoid the ingestion of milk and dairy products, while others substitute non-lactose containing products in their diet. Based on the health implications from insufficient calcium intake over a lifetime, including increased risk of osteoporosis and hypertension, there is need in the medical community for a tolerable and convenient treatment that allows for all levels of milk and dairy product consumption in people suffering from mild to severe lactose intolerance. This study will evaluate a treatment that provides a simplified dosing regimen as well as the potential for extended relief from symptoms following a limited therapy regimen.
Interventions
DRUGRP-G28 or placebo
Qualified subjects randomized to daily dosing with RP-G28 or placebo
Sponsors
Ritter Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects. Female subjects must be non-pregnant and non-lactating. * 18 to 64 years of age inclusive at Screening * Current or recent history of intolerance to milk and other dairy products * Acceptable Baseline Lactose Intolerance Symptom Scores * Acceptable Result on Baseline Hydrogen Breath Test * Subjects must agree to refrain from all other treatments and products used for lactose intolerance during the study
Exclusion criteria
* Disorders known to be associated with abnormal GI motility * History of surgery that alters the normal function of the gastrointestinal tract * Past or present; organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS) * Active gastric or duodenal ulcers or history of severe ulcers * Diabetes mellitus (type 1 or type 2) * Congestive Heart Failure * History of Human Immunodeficiency Virus (HIV), Hepatitis B or C * Use of concurrent therapy(ies) for symptoms of lactose intolerance * Uncontrolled BP defined as sitting systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥95 mmHg at Visit 1 * History of ethanol abuse in the past 12 months * History of drug abuse within 12 months * History or presence of malignancy within the past 5 years (except basal cell or squamous cell carcinoma removed from a sun-exposed area) * Use of any investigational drug or participation in any investigational study within 30 days prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge | Baseline, 36 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects with Adverse Events as Measure of Safety and Tolerability | 36 days | Number of Subjects with Adverse Events as a Measure of Safety and Tolerability |
Countries
United States
Outcome results
None listed