Clinical trial NCT01113619: Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effectiveness, Safety and Tolerability of RP-G28 in Subjects With Symptoms Associated With Lactose Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lactose Intolerance
Keywords: lactose maldigestion
dairy intolerance
intolerance to milk
intolerance to dairy
milk intolerance
GI disorder
lactose metabolism
GI symptoms after dairy ingestion
Lead sponsor: Ritter Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1) Change from Baseline in breath hydrogen production on Hydrogen Breath Test. 2) Change from Baseline in lactose intolerance symptom assessment during lactose challenge
timeFrame: Baseline, 36 days
Secondary outcomes:
measure: Number of Subjects with Adverse Events as Measure of Safety and Tolerability
timeFrame: 36 days
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Covance, Inc. - Honolulu
state: Hawaii
city: Dallas
country: United States
facility: Covance, Inc. - Dallas
state: Texas
Study officials:
References:
citation: Savaiano DA, Ritter AJ, Klaenhammer TR, James GM, Longcore AT, Chandler JR, Walker WA, Foyt HL. Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial. Nutr J. 2013 Dec 13;12:160. doi: 10.1186/1475-2891-12-160.