{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T10:57:37Z","timestamp":1784977057840,"version":"3.55.0"},"reference-count":21,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2020,4,10]],"date-time":"2020-04-10T00:00:00Z","timestamp":1586476800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Background and Aims: Lactose intolerance (LI) is a global problem affecting more than half of the world\u2019s 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 \u22654-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\u2019 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 \u22654-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.<\/jats:p>","DOI":"10.3390\/nu12041058","type":"journal-article","created":{"date-parts":[[2020,4,13]],"date-time":"2020-04-13T04:45:31Z","timestamp":1586753131000},"page":"1058","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Galacto-Oligosaccharide RP-G28 Improves Multiple Clinical Outcomes in Lactose-Intolerant Patients"],"prefix":"10.3390","volume":"12","author":[{"given":"William","family":"Chey","sequence":"first","affiliation":[{"name":"Gastroenterology and Nutrition Sciences 3912 Taubman Center, SPC 5362, Ann Arbor, MI 48109, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Sandborn","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, University of California San Diego, San Diego, CA 92093, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J.","family":"Ritter","sequence":"additional","affiliation":[{"name":"Ritter Pharmaceuticals, Inc., Los Angeles, CA 90067, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard","family":"Foyt","sequence":"additional","affiliation":[{"name":"Ritter Pharmaceuticals, Inc., Los Angeles, CA 90067, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0325-1289","authenticated-orcid":false,"given":"M. Andrea","family":"Azcarate-Peril","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology and Hepatology and UNC Microbiome Core, School of Medicine, University of North Carolina at Chapel Hill, NC 27514, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8872-6276","authenticated-orcid":false,"given":"Dennis A.","family":"Savaiano","sequence":"additional","affiliation":[{"name":"Meredith Professor of Nutrition Science, Institution: Purdue University, West Lafayette, IN 47907, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2020,4,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1007\/s11894-017-0558-9","article-title":"Lactase Non-persistence and Lactose Intolerance","volume":"19","author":"Bayless","year":"2017","journal-title":"Curr. Gastroenterol. 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