Efficacy, Safety, and Tolerability Study of RP-G28 in Subjects With Lactose Intolerance

NCT ID: NCT02673749

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 377 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-10-31

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.

Conditions

Lactose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RP-G28 Dose 1

Group Type: EXPERIMENTAL

RP-G28

Intervention Type: DRUG

Study drug taken orally

RP-G28 Dose 2

Group Type: EXPERIMENTAL

RP-G28

Intervention Type: DRUG

Study drug taken orally

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo taken orally

Interventions

RP-G28

Study drug taken orally

Intervention Type: DRUG

Placebo

Placebo taken orally

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ritter Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance, Inc.

Princeton, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34365905 (View on PubMed)

Other Identifiers

G28-003

Identifier Type: -

Identifier Source: org_study_id