{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:51:10Z","timestamp":1782845470057,"version":"3.54.5"},"reference-count":15,"publisher":"JMIR Publications Inc.","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Form Res"],"abstract":"\n Background<\/jats:title>\n Lactose malabsorption is a common condition that affects a broad segment of the population. Clinical diagnosis based on symptom recall can be unreliable and conventional testing can be inconvenient, requiring expensive laboratory-based equipment and conduction of the testing in a clinical setting.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n The aim of this study is to assess the performance of a digital handheld hydrogen breath monitor (GIMate) in diagnosing lactose malabsorption compared to a US Food and Drug Administration (FDA)\u2013cleared device (H2 Check) for the same indication.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n An interventional crossover study was performed in adult participants with a prior confirmed diagnosis of lactose malabsorption or a suspected history of lactose intolerance.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 31 participants (mean age 33.9 years) were enrolled in the study. There was 100% positive percent agreement and 100% negative percent agreement between the GIMate monitor and the H2 Check. Correlation between gastrointestinal symptoms and hydrogen values was positive at 0.82 (P<.001).<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The digital handheld GIMate breath monitor achieved equivalent diagnostic performance to that of an FDA-cleared device in the diagnosis of lactose malabsorption.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n ClinicalTrials.gov NCT04754724; https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04754724<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/33009","type":"journal-article","created":{"date-parts":[[2021,9,20]],"date-time":"2021-09-20T19:59:17Z","timestamp":1632167957000},"page":"e33009","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of a Digital Handheld Hydrogen Breath Monitor to Diagnose Lactose Malabsorption: Interventional Crossover Study"],"prefix":"10.2196","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1961-3360","authenticated-orcid":false,"given":"Simon C","family":"Mathews","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2844-2647","authenticated-orcid":false,"given":"Sandy","family":"Templeton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9805-1639","authenticated-orcid":false,"given":"Stephanie K","family":"Taylor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6425-9108","authenticated-orcid":false,"given":"Sten","family":"Harris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9905-9982","authenticated-orcid":false,"given":"Margaret","family":"Stewart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0216-1564","authenticated-orcid":false,"given":"Shruti M","family":"Raja","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2021,10,18]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v12.i2.187"},{"issue":"6","key":"ref2","doi-asserted-by":"crossref","first-page":"1125","DOI":"10.1016\/S0016-5085(72)80080-5","volume":"62","author":"Gilat, T","year":"1972","journal-title":"Gastroenterology"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1016\/s0016-5085(98)70429-9"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2001.00952.x"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1097\/00004836-199904000-00005"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1093\/qjmed\/hcq082"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1080\/00365519850186607"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2017.46"},{"key":"ref9","unstructured":"Instructions for patientsJohns Hopkins Medicine Gastroenterology and Hepatology Breath Testing Services2021-08-10https:\/\/www.hopkinsmedicine.org\/gastroenterology_hepatology\/_forms\/patient_info\/Breath_test_instructions_updated_6_5_18.pdf"},{"key":"ref10","unstructured":"510(k) Premarket NotificationUS Food and Drug Administration2021-08-10https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm?ID=K963376"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1046\/j.1440-1754.2000.00511.x"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.3390\/nu11071636"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.2196\/25371"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.2196\/22811"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.2196\/resprot.8768"}],"container-title":["JMIR Formative Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/formative.jmir.org\/2021\/10\/e33009","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T17:51:23Z","timestamp":1782841883000},"score":1,"resource":{"primary":{"URL":"https:\/\/formative.jmir.org\/2021\/10\/e33009"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10,18]]},"references-count":15,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.2196\/33009","relation":{"has-preprint":[{"id-type":"doi","id":"10.2196\/preprints.33009","asserted-by":"object"}]},"ISSN":["2561-326X"],"issn-type":[{"value":"2561-326X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,10,18]]}}}