NCT02673749

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

Completed Phase 2/Phase 3 Last updated 2 April 2018

What this trial tests

Phase 2/Phase 3 trial testing RP-G28 in Lactose Intolerance in 377 participants. Completed in 1 October 2016.

Timeline

1 February 2016

Primary endpoint
1 October 2016

1 October 2016

Quick facts

Lead sponsor	Ritter Pharmaceuticals, Inc.
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	377
Start date	1 February 2016
Primary completion	1 October 2016
Estimated completion	1 October 2016
Sites	1 location across United States

Drugs / interventions tested

• RP-G28 — full drug profile →
• Placebo

Conditions studied

• Lactose Intolerance — all drugs for Lactose Intolerance →

Sponsor

Ritter Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Lactose Intolerance. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline in abdominal pain
  Time frame: Day 31
  Percent change from baseline to Day 31 of AUC abdominal pain symptom score based on measures taken after a lactose challenge test at 1, 2, 3, 4, and 5 hours. The method of assessment for this outcome measure is an 11-point numeric rating scale completed by the subject.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A double-blind, 377-subject randomized study identifies <i>Ruminococcus, Coprococcus, Christensenella</i>, and <i>Collinsella</i> as long-term potential key players in the modulation of the gut microbiome of lactose intolerant individuals by galacto-oligosaccharides.
   Azcarate-Peril MA, Roach J, Marsh A, Chey WD, et al · · 2021 · cited 25× · PMID 34365905 · DOI 10.1080/19490976.2021.1957536
2. Galacto-Oligosaccharide RP-G28 Improves Multiple Clinical Outcomes in Lactose-Intolerant Patients.
   Chey W, Sandborn W, Ritter AJ, Foyt H, et al · · 2020 · cited 13× · PMID 32290344 · DOI 10.3390/nu12041058