Clinical trial NCT02673749: Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance
Official title: A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Two Doses of RP-G28 in Subjects With Lactose Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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: 2016-02-04
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RP-G28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products).

Detailed description: Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming 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, cramping, 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. Currently, there are no approved treatments for this condition.

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.

Study Objective:

To access efficacy of two RP-G28 dosing regimes on symptoms related to lactose intolerance relative to placebo after 30 days of treatment. The 30 day post-treatment phase will further evaluate the treatment's potential to prolong relief from symptoms.

Study Design:

The participants will take about 60 days to complete the study. The study consists of 3 distinct phases: Screening, a 30-day Treatment Phase, and a 30-day Post-Treatment Phase (off study treatment observation period). A participant will need to visit the clinical only 6 times throughout the study.

Eligibility criteria: Inclusion/Exclusion Criteria:

* Female subjects must be non pregnant, and non lactating. Females of childbearing potential must use adequate birth control during study participation
* Medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance.
* Must be free from any disorder known to be associated with gastrointestinal disease: irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), ulcerative colitis (UC), Crohn's disease (CD), Celiac disease, diverticulitis, chronic constipation, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, small intestine bacterial overgrowth syndrome (SIBO), active gastric or duodenal ulcers, or history of severe ulcers.
* Must be nicotine free.

Primary outcomes:
measure: Change from baseline in abdominal pain
timeFrame: Day 31
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Covance, Inc.
state: New Jersey
Study officials:
References:
citation: Azcarate-Peril MA, Roach J, Marsh A, Chey WD, Sandborn WJ, Ritter AJ, Savaiano DA, Klaenhammer TR. A double-blind, 377-subject randomized study identifies Ruminococcus, Coprococcus, Christensenella, and Collinsella as long-term potential key players in the modulation of the gut microbiome of lactose intolerant individuals by galacto-oligosaccharides. Gut Microbes. 2021 Jan-Dec;13(1):1957536. doi: 10.1080/19490976.2021.1957536.