RP-G28 / Qualigen Therap - LARVOL DELTA

The use of probiotics and prebiotics can enable the ingestion of dairy products by lactose intolerant individuals. (PubMed, Clin Nutr) - "In summary, the probiotics Limosilactobacillus reuteri DSM 17938 and Lactobacillus acidophilus DDS-1 showed the best results in the management of LI symptoms. The prebiotic GOS (RP-G28) appeared to be more efficient in reducing post-treatment symptoms. However, it is noteworthy that evidence regarding the use of probiotics for the management of LI is considerably scarce; as for prebiotics, data are limited. Studies adopting robust methodologies, especially regarding the complete reporting of data, are therefore warranted."

Journal • Gastrointestinal Disorder • Metabolic Disorders

Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Adult Male and Female Subjects (clinicaltrials.gov) - P1; N=14; Completed; Sponsor: Ritter Pharmaceuticals, Inc.

New P1 trial • Biosimilar

Galacto-Oligosaccharide RP-G28 Improves Multiple Clinical Outcomes in Lactose-Intolerant Patients. (PubMed, Nutrients) - " RP-G28 for 30 days significantly reduced symptoms and altered the fecal microbiome in patients with LI. Treatment with RP-G28 also improved milk/dairy consumption and quality of life and was safe and well tolerated."

Clinical • Clinical data • Journal • CNS Disorders • Pain

Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance (clinicaltrials.gov) - P3; N=557; Completed; Sponsor: Ritter Pharmaceuticals, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion

Ritter Pharmaceuticals announces last patient last visit in its phase 3 ‘Liberatus’ clinical trial of RP-G28 for lactose intolerance (GlobeNewswire) - "'RP-G28 is potentially a breakthrough therapy for patients with LI as there are few effective treatment options available today,' said William J. Sandborn, M.D....'The novel mode of action of RP-G28 based on gut modulation has shown great promise and I'm encouraged by this study's potential to validate the capabilities of gut microbiome modulating therapies while also evaluating relevant clinical outcomes.'"

Media quote

Evaluation of the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance (clinicaltrials.gov) - P3; N=557; Active, not recruiting; Sponsor: Ritter Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed