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Studies have shown high mortality in Tanzanian children with ESBL-E infections. Gut colonization of ESBL-E, which is a potential risk factor of ESBL-E infections, is reported to be very high among children in Tanzania. Probiotics may potentially reduce gut colonization of multidrug-resistant bacteria. However, there is limited data on whether probiotics may reduce ESBL-E carriage in infants. The ProRIDE Trial aims to evaluate whether the use of probiotics can reduce morbidity and mortality among infants in Haydom, Tanzania, and whether this effect is associated with a reduction in ESBL-E colonization and\/or infections.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods\/design<\/jats:title>\n                <jats:p>This large randomized double-blinded placebo-controlled trial aims to recruit 2000 newborn infants at Haydom Lutheran Hospital and the surrounding area in the period of November 2020 to November 2021. Participants will be enrolled from days 0 to 3 after birth and randomized to receive probiotics or placebo for 4 weeks. Participants will be followed-up for 6 months, during which three visits will be made to collect clinical and demographic information, as well as rectal swabs and fecal samples which will be subjected to laboratory analysis. The primary composite outcome is the prevalence of death and\/or hospitalization at 6 months of age.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>As the use of probiotics may give a more favorable gut composition, and thereby improve health and reduce morbidity and mortality, the results may have implications for future therapy guidelines in Africa and internationally.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> NCT04172012. Registered on November 21, 2019<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-021-05251-3","type":"journal-article","created":{"date-parts":[[2021,4,29]],"date-time":"2021-04-29T07:03:22Z","timestamp":1619679802000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1302-950X","authenticated-orcid":false,"given":"Kanika","family":"Kuwelker","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Langeland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iren H\u00f8yland","family":"L\u00f6hr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua","family":"Gidion","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Manyahi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina John","family":"Moyo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bj\u00f8rn","family":"Blomberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus","family":"Klingenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,4,29]]},"reference":[{"issue":"1","key":"5251_CR1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2015-007675","volume":"6","author":"AM Kipp","year":"2016","unstructured":"Kipp AM, Blevins M, Haley CA, Mwinga K, Habimana P, Shepherd BE, et al. 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Ethical approval of the ProRIDE Trial has been obtained from the Regional Committee for Medical and Health Research Ethics Western Norway in September 2019 (REK Vest 2019\/1025) (see \u201cAdditional file \u201d) and from the National Institute of Medical Research in Tanzania (NIMR) in April 2020 (see \u201cAdditional file \u201d). The formal application to conduct the RCT in Tanzania has in June 2020 been submitted to the regulatory authority; Tanzania Medicines and Medical Devices Authority (TMDA). A response to queries raised by TMDA was submitted in December 2020. Approval has been obtained from TMDA, but technical issues have caused delays in the release of the certificate. Parent\/caretaker will receive oral and written information about the trial and must give a written informed consent before their involvement in the trial. All information is translated in Kiswahili and trained investigators participating in the recruitment process speak the local languages. Participants are free to withdraw from the trial at any time.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"No individual or sensitive data relating to an individual person will be published. Thus, we do not need an informed consent from a person or a parent\/legal guardian for the final publication.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"312"}}