{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,1,16]],"date-time":"2026-01-16T12:35:18Z","timestamp":1768566918167,"version":"3.49.0"},"posted":{"date-parts":[[2024,1,5]]},"group-title":"Endocrinology (including Diabetes Mellitus and Metabolic Disease)","reference-count":41,"publisher":"openRxiv","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2024,1,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:p>\n                  Individuals with cystic fibrosis (CF) have dysfunctional intestinal microbiota and increased gastrointestinal (GI) inflammation also known as GI dysbiosis. It is hypothesized that administration of high-dose cholecalciferol (vitamin D\n                  <jats:sub>3<\/jats:sub>\n                  ) together with a prebiotic (inulin) will be effective, and possibly additive or synergistic, in reducing CF-related GI dysbiosis and improving intestinal functions. Thus, a 2 \u00d7 2 factorial design, placebo-controlled, double-blind, clinical trial was proposed to test this hypothesis. Forty adult participants with CF will be block-randomized into one of four groups: 1) high-dose oral vitamin D\n                  <jats:sub>3<\/jats:sub>\n                  (50,000 IU weekly) plus oral prebiotic placebo daily; 2) oral prebiotic (12 g inulin daily) plus oral placebo vitamin D\n                  <jats:sub>3<\/jats:sub>\n                  weekly; 3) combined oral vitamin D\n                  <jats:sub>3<\/jats:sub>\n                  weekly and oral prebiotic inulin daily; and 4) oral vitamin D\n                  <jats:sub>3<\/jats:sub>\n                  placebo weekly and oral prebiotic placebo. The primary endpoints will include 12-week changes in the reduced relative abundance of gammaproteobacteria, and gut microbiota richness and diversity before and after the intervention. This clinical study will examine whether vitamin D\n                  <jats:sub>3<\/jats:sub>\n                  with or without prebiotics will improve intestinal health and reduce GI dysbiosis, which in turn, should improve health outcomes and quality of life of patients with CF.\n                <\/jats:p>","DOI":"10.1101\/2024.01.04.24300860","type":"posted-content","created":{"date-parts":[[2024,1,10]],"date-time":"2024-01-10T01:36:49Z","timestamp":1704850609000},"source":"Crossref","is-referenced-by-count":0,"title":["Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis: Rationale and design for a randomized, placebo-controlled, double-blind, 2 \u00d7 2 trial of administration of prebiotics and cholecalciferol (vitamin D\n                  <sub>3<\/sub>\n                  ) (Pre-D Trial) in adults with cystic fibrosis"],"prefix":"10.64898","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-7531-6740","authenticated-orcid":false,"given":"Alisa K.","family":"Sivapiromrat","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pichatorn","family":"Suppakitjanusant","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanling","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jose","family":"Binongo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William R.","family":"Hunt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Gewirtz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica A.","family":"Alvarez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chengcheng","family":"Hu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samuel","family":"Weinstein","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ishaan","family":"Jathal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas R.","family":"Ziegler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vin","family":"Tangpricha","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"54368","reference":[{"key":"2024010921524566000_2024.01.04.24300860v1.1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200701-160UP"},{"key":"2024010921524566000_2024.01.04.24300860v1.2","doi-asserted-by":"publisher","DOI":"10.1007\/s00018-016-2391-y"},{"key":"2024010921524566000_2024.01.04.24300860v1.3","doi-asserted-by":"publisher","DOI":"10.3390\/metabo11020123"},{"key":"2024010921524566000_2024.01.04.24300860v1.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2015.02.049"},{"key":"2024010921524566000_2024.01.04.24300860v1.5","doi-asserted-by":"publisher","DOI":"10.1097\/MCO.0000000000000209"},{"issue":"1","key":"2024010921524566000_2024.01.04.24300860v1.6","first-page":"43","article-title":"Gastrointestinal Manifestations of Cystic Fibrosis","volume":"12","year":"2016","journal-title":"Gastroenterol Hepatol (N Y"},{"key":"2024010921524566000_2024.01.04.24300860v1.7","doi-asserted-by":"publisher","DOI":"10.1038\/srep24857"},{"key":"2024010921524566000_2024.01.04.24300860v1.8","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1714373115"},{"key":"2024010921524566000_2024.01.04.24300860v1.9","doi-asserted-by":"publisher","DOI":"10.1186\/s12866-017-1006-6"},{"key":"2024010921524566000_2024.01.04.24300860v1.10","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0061176"},{"key":"2024010921524566000_2024.01.04.24300860v1.11","doi-asserted-by":"publisher","DOI":"10.4161\/gmic.22430"},{"key":"2024010921524566000_2024.01.04.24300860v1.12","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0000000000000683"},{"key":"2024010921524566000_2024.01.04.24300860v1.13","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0198457"},{"key":"2024010921524566000_2024.01.04.24300860v1.14","doi-asserted-by":"publisher","DOI":"10.1007\/s12519-017-0033-6"},{"key":"2024010921524566000_2024.01.04.24300860v1.15"},{"key":"2024010921524566000_2024.01.04.24300860v1.16","doi-asserted-by":"publisher","DOI":"10.1016\/j.carbpol.2016.04.020"},{"key":"2024010921524566000_2024.01.04.24300860v1.17","doi-asserted-by":"publisher","DOI":"10.1038\/srep21641"},{"key":"2024010921524566000_2024.01.04.24300860v1.18","doi-asserted-by":"publisher","DOI":"10.1111\/1751-2980.12591"},{"key":"2024010921524566000_2024.01.04.24300860v1.19","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2017-01983"},{"key":"2024010921524566000_2024.01.04.24300860v1.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.metabol.2017.02.006"},{"key":"2024010921524566000_2024.01.04.24300860v1.21","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsbmb.2016.11.001"},{"key":"2024010921524566000_2024.01.04.24300860v1.22","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-1279"},{"key":"2024010921524566000_2024.01.04.24300860v1.23","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsbmb.2015.09.013"},{"key":"2024010921524566000_2024.01.04.24300860v1.24","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2011-3050"},{"key":"2024010921524566000_2024.01.04.24300860v1.25","doi-asserted-by":"crossref","unstructured":"Ferguson J.H. , Chang A.B . Vitamin D supplementation for cystic fibrosis. Chrane Database Syst. Rev. 2014 May 14;(5):CD007298","DOI":"10.1002\/14651858.CD007298.pub4"},{"key":"2024010921524566000_2024.01.04.24300860v1.26","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2008-2012"},{"key":"2024010921524566000_2024.01.04.24300860v1.27","doi-asserted-by":"publisher","DOI":"10.3390\/nu10020201"},{"key":"2024010921524566000_2024.01.04.24300860v1.28","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2016-313271"},{"issue":"3","key":"2024010921524566000_2024.01.04.24300860v1.29","doi-asserted-by":"crossref","first-page":"711","DOI":"10.1053\/j.gastro.2017.05.055","article-title":"Prebiotics Reduce Body Fat and Alter Intestinal Microbiota in Children Who Are Overweight or With Obesity","volume":"153","year":"2017","journal-title":"Gastroenterology"},{"key":"2024010921524566000_2024.01.04.24300860v1.30","doi-asserted-by":"publisher","DOI":"10.3390\/nu10030286"},{"key":"2024010921524566000_2024.01.04.24300860v1.31","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2013-3598"},{"key":"2024010921524566000_2024.01.04.24300860v1.32","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ejhg.5200850"},{"key":"2024010921524566000_2024.01.04.24300860v1.33","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02555-14"},{"key":"2024010921524566000_2024.01.04.24300860v1.34","doi-asserted-by":"publisher","DOI":"10.1007\/s00335-015-9560-4"},{"key":"2024010921524566000_2024.01.04.24300860v1.35","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200812-1845PP"},{"key":"2024010921524566000_2024.01.04.24300860v1.36","doi-asserted-by":"publisher","DOI":"10.2146\/ajhp090168"},{"key":"2024010921524566000_2024.01.04.24300860v1.37","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcte.2021.100273"},{"key":"2024010921524566000_2024.01.04.24300860v1.38","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcf.2019.08.022"},{"key":"2024010921524566000_2024.01.04.24300860v1.39","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.2008.03216.x"},{"key":"2024010921524566000_2024.01.04.24300860v1.40","doi-asserted-by":"publisher","DOI":"10.3390\/nu13114048"},{"key":"2024010921524566000_2024.01.04.24300860v1.41","doi-asserted-by":"publisher","DOI":"10.4161\/derm.20332"}],"container-title":[],"original-title":[],"link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1101\/2024.01.04.24300860","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T19:47:47Z","timestamp":1768506467000},"score":1,"resource":{"primary":{"URL":"http:\/\/medrxiv.org\/lookup\/doi\/10.1101\/2024.01.04.24300860"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1,5]]},"references-count":41,"URL":"https:\/\/doi.org\/10.1101\/2024.01.04.24300860","relation":{"is-preprint-of":[{"id-type":"doi","id":"10.1016\/j.conctc.2024.101278","asserted-by":"subject"}]},"subject":[],"published":{"date-parts":[[2024,1,5]]},"subtype":"preprint"}}