A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients With Lactose Intolerance

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the United States (US) to assess the efficacy of RP-G28 compared to placebo on symptom reduction related to lactose intolerance.

Start Date26 Jun 2018

Sponsor / Collaborator

Ritter Pharmaceuticals, Inc.

NCT03563846 / CompletedPhase 1

Prospective, Open-Label, Randomized, Two-Period, Two-Sequence, Crossover Study Comparing RP-G28 Administered in the Fasted State and the Effect of a Standard Meal on the Pharmacokinetic Profile of RP-G28 in Healthy Volunteers

Randomized, open-label, 2-period, 2-sequence, crossover study to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28.

Start Date09 Mar 2018

Sponsor / Collaborator

Ritter Pharmaceuticals, Inc.

NCT02673749 / CompletedPhase 2/3

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

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

Start Date01 Feb 2016

Sponsor / Collaborator

Ritter Pharmaceuticals, Inc.

100 Clinical Results associated with RP-G28

100 Translational Medicine associated with RP-G28

100 Patents (Medical) associated with RP-G28

Literatures (Medical) associated with RP-G28

01 Dec 2022·Clinical Nutrition

The use of probiotics and prebiotics can enable the ingestion of dairy products by lactose intolerant individuals

Review

Author: Oliveira, Luiza Scalcon de ; Casaril, Kérley Braga Pereira Bento ; Crestani, Ana Paula Jaqueline ; Wendt, Guilherme Welter

OBJECTIVETo investigate, through a systematic review, the efficiency of the clinical application of probiotic and prebiotic supplements in reducing the symptoms of lactose intolerance (LI).METHODSThis systematic review was conducted without limits for publication time and followed the PRISMA 2020 guidelines. The study was registered at the PROSPERO platform (CRD42022295691). The inclusion criteria were: studies addressing the issue of LI associated with the use of probiotics and prebiotics of any nature; studies performed with adults; randomized, placebo-controlled trials; and open access scientific articles, theses, or dissertations. The studies were retrieved from the following databases: SciELO, PubMed, LILACS, ScienceDirect, and gray literature, with no restrictions imposed regarding the years of publication of the investigations. To document the risk of bias, the RoB 2.0 tool was adopted, and to assess the certainty of the evidence, the GRADE tool was used.RESULTSA total of 830 studies were found; however, after applying the inclusion and exclusion criteria, only five studies remained. Two studies used the prebiotic GOS (RP-G28) for the treatment of LI and, together, included 462 subjects. The results of these studies showed improvement of LI symptoms during treatment phase and up to 30 days after cessation of GOS use (RP-G28). Three studies used the probiotics Bifidobacterium bifidum 900791, Limosilactobacillus reuteri DSM 17938 (Lactobacillus reuteri), and Lactobacillus acidophilus DDS-1 to evaluate their effects on LI and comprised 117 subjects. The results showed that B. bifidum 900791 did not significantly improve LI symptoms, and only Limosilactobacillus reuteri DSM 17938 showed significant improvement in symptoms and in reduction of expired hydrogen, while Lactobacillus acidophilus DDS-1 showed significant improvement for LI symptoms. The risk of bias for studies on probiotics suggested concerns in all studies, whereas the risk of bias was low in investigations evaluating prebiotics, with only one study classified as concerning. The certainty of evidence was high for the studies using the GOS (RP-G28) prebiotic and low for the probiotics. Pooling for meta-analysis could not be performed due to the lack of similar probiotic strains or lack of common outcomes.CONCLUSIONIn 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.

01 Dec 2013·Nutrition JournalQ3 · MEDICINE

Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial

Q3 · MEDICINE

ArticleOA

Author: Todd R Klaenhammer ; Justin R Chandler ; W Allan Walker ; Howard L Foyt ; Dennis A Savaiano ; Gareth M James ; Amy T Longcore ; Andrew J Ritter

BACKGROUNDLactose intolerance (LI) is a common medical problem with limited treatment options. The primary symptoms are abdominal pain, diarrhea, bloating, flatulence, and cramping. Limiting dairy foods to reduce symptoms contributes to low calcium intake and the risk for chronic disease. Adaptation of the colon bacteria to effectively metabolize lactose is a novel and potentially useful approach to improve lactose digestion and tolerance. RP-G28 is novel galacto-oligosaccharide (GOS) being investigated to improve lactose digestion and the symptoms of lactose intolerance in affected patients.METHODSA randomized, double-blind, parallel group, placebo-controlled study was conducted at 2 sites in the United States. RP-G28 or placebo was administered to 85 patients with LI for 35 days. Post-treatment, subjects reintroduced dairy into their daily diets and were followed for 30 additional days to evaluate lactose digestion as measured by hydrogen production and symptom improvements via a patient-reported symptom assessment instrument.RESULTSLactose digestion and symptoms of LI trended toward improvement on RP-G28 at the end of treatment and 30 days post-treatment. A reduction in abdominal pain was also demonstrated in the study results. Fifty percent of RP-G28 subjects with abdominal pain at baseline reported no abdominal pain at the end of treatment and 30 days post treatment (p = 0.0190). RP-G28 subjects were also six times more likely to claim lactose tolerance post-treatment once dairy foods had been re-introduced into their diets (p = 0.0389).CONCLUSIONSEfficacy trends and favorable safety/tolerability findings suggest that RP-G28 appears to be a potentially useful approach for improving lactose digestion and LI symptoms. The concurrent reduction in abdominal pain and improved overall tolerance could be a meaningful benefit to lactose intolerant individuals.

NutrientsQ2 · MEDICINE

Galacto-Oligosaccharide RP-G28 Improves Multiple Clinical Outcomes in Lactose-Intolerant Patients

Q2 · MEDICINE

ArticleOA

Author: Ritter, Andrew J ; Foyt, Howard ; Sandborn, William ; Chey, William ; Azcarate-Peril, M Andrea ; Savaiano, Dennis A

Background and Aims: Lactose intolerance (LI) is a global problem affecting more than half of the world’s population. An ultra-purified, high-concentration galacto-oligosaccharide, RP-G28, is being developed as a treatment for patients with LI. The efficacy and safety of RP-G28 in reducing symptoms of lactose intolerance were assessed in a blinded, randomized, placebo-controlled trial. Methods: In this multiclinical site, double-blinded, placebo-controlled trial, 377 patients with LI were randomized to one of two doses of orally administered RP-G28 or placebo for 30 days. A LI test and symptom assessment were performed at baseline and on day 31. The primary endpoint was a ≥4-point reduction or a score of zero on LI composite score on day 31. Voluntary milk and dairy intake and global outcome measures assessed patients’ overall treatment satisfaction and quality of life before therapy and 30 days after therapy. This study received Institutional Review Board (IRB) approval. Results: For the primary endpoint, 40% in the RP-G28 groups reported a ≥4-point reduction or no symptoms on LI symptom composite score compared to 26% with placebo (p = 0.016). Treatment with RP-G28 also led to significantly higher levels of milk and dairy intake and significant improvements in global assessments compared to placebo. RP-G28 but not placebo led to significant increases in five Bifidobacterium taxa. Conclusions: 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.

100 Deals associated with RP-G28

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Lactose Intolerance	Phase 3	US	Ritter Pharmaceuticals, Inc.	26 Jun 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02673749 (Pubmed) Manual	Phase 2/3	Lactose Intolerance	377	Galacto-Oligosaccharide RP-G28	whwdqamiac(sjxygiqgny) = bvmlvwbyvr ebvvfelsxc (wxiatefhvq ) Met	Positive	10 Apr 2020
				Placebo	whwdqamiac(sjxygiqgny) = nsgikwadef ebvvfelsxc (wxiatefhvq ) Met
NCT03597516 (GlobeNewswire) Manual	Phase 3	Lactose Intolerance	557	RP-G28	(jpbtojybap) = aocixguifl vzmbcuxsfu (vaprwemjot ) View more	Negative	12 Sep 2019
				Placebo	(jpbtojybap) = cdkuhnxxst vzmbcuxsfu (vaprwemjot ) View more

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