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It is characterized by dry mouth, erythema, mucosal soreness, ulcers, and pain, and it may impact patient outcomes. Bovine colostrum and <jats:italic>Aloe vera<\/jats:italic> contain a wide variety of biologically active compounds that promote mucosal healing. A non-randomized phase II study was designed to assess the safety and efficacy of a combined bovine colostrum and <jats:italic>Aloe vera<\/jats:italic> oral care protocol to prevent and to treat severe oral mucositis in transplant patients. Two commercially available products were given to patients in addition to the standard protocol: Remargin Colostrum OS\u00ae mouthwash and Remargin Colostrum Gastro-Gel\u00ae taken orally. Forty-six (78.0%) patients experienced oral mucositis, 40 (67.8%) developed mild\u2013moderate forms, and 6 (10.2%) severe ones. Comparing the study group\u2019s outcomes with those of a homogeneous historical control group, severe oral mucositis decreased significantly (10.2% vs. 28.4%; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.01), as did its duration (0.5\u2009\u00b1\u20091.9 vs. 1.5\u2009\u00b1\u20093.0\u00a0days; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.01). Febrile neutropenia episodes (69.5% vs. 95.1%; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.01) and duration (4.0\u2009\u00b1\u20094.7 vs. 6.2\u2009\u00b1\u20094.5\u00a0days; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.01) also decreased. These findings show that the experimental protocol seems effective in preventing severe forms of oral mucositis. However, a randomized controlled trial is necessary to confirm this.<\/jats:p>","DOI":"10.1007\/s00277-022-04934-4","type":"journal-article","created":{"date-parts":[[2022,8,3]],"date-time":"2022-08-03T16:03:09Z","timestamp":1659542589000},"page":"2325-2336","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy and safety of a colostrum- and Aloe vera-based oral care protocol to prevent and treat severe oral mucositis in patients undergoing hematopoietic stem cell transplantation: a single-arm phase II study"],"prefix":"10.1007","volume":"101","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4393-1027","authenticated-orcid":false,"given":"Monica","family":"Guberti","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0678-0242","authenticated-orcid":false,"given":"Stefano","family":"Botti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristiana","family":"Caffarri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Cavuto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luisa","family":"Savoldi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Fusco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0979-7883","authenticated-orcid":false,"given":"Francesco","family":"Merli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5998-476X","authenticated-orcid":false,"given":"Michela","family":"Piredda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7039-6280","authenticated-orcid":false,"given":"Maria Grazia","family":"De Marinis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,8,3]]},"reference":[{"issue":"1","key":"4934_CR1","doi-asserted-by":"publisher","first-page":"33","DOI":"10.12968\/hmed.2019.80.1.33","volume":"80","author":"K Balassa","year":"2019","unstructured":"Balassa K, Danby R, Rocha V (2019) Haematopoietic stem cell transplants: principles and indications. 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