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Complaints include infrequent bowel movements, painful defecation due to hard and\/or large stools, faecal incontinence, and abdominal pain. Prebiotic oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking linking additional prebiotic intake to improve symptoms in children with FC. We hypothesise that prebiotic oligosaccharides are able to relieve symptoms of constipation in young children as well.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In the present randomised, double-blind, placebo-controlled, multi-centre study, we will study the effects of two prebiotic oligosaccharides in comparison to placebo on constipation symptoms in children of 1\u20135 years (12 to 72 months) of age diagnosed with FC according to the Rome IV criteria for functional gastrointestinal disorders. The primary outcome measure will be change in stool consistency. Secondary outcomes include stool frequency and stool consistency in a number of cases (%). Tertiary outcomes include among others painful defecation, use of rescue medication, and quality of life. In addition, the impact on gut microbiome outcomes such as faecal microbiota composition and metabolites will be investigated. Participants start with a run-in period, after which they will receive supplements delivered in tins with scoops for 8 weeks, containing one of the two prebiotic oligosaccharides or placebo, followed by a 4-week wash-out period.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This randomised double-blind, placebo-controlled multi-centre study will investigate the effectiveness of prebiotic oligosaccharides in children aged 1\u20135 years with FC.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov NCT04282551. Registered on 24 February 2020.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08050-8","type":"journal-article","created":{"date-parts":[[2024,4,5]],"date-time":"2024-04-05T01:50:53Z","timestamp":1712281853000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7963-7634","authenticated-orcid":false,"given":"Carrie A. M.","family":"Wegh","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margriet H. 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This study is conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013) and in accordance with the WMO. Informed consent has to be signed by, if applicable, both parents before any study-related activities. Moreover, legally required participant insurance and liability insurance are in place.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Written consent is obtained from participants to use their anonymized data for reporting and publication purposes. Results will be published in peer-reviewed journals in which codes of conduct will be followed for authorships, openness of publications, data and statistical code.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"C.A.M.W. and S.C.C.Z. are supported by a grant from TKI (AF17067), FrieslandCampina and Sensus, M.H.C.S. is an employee of FrieslandCampina, E.E.V. is an employee of Sensus (Royal Cosun), M.A.B. has acted as a consultant for Shire, Sucampo, AstraZeneca, Norgine, Allergan, Mallinckrodt, Coloplast, Danone, FrieslandCampina, Sensus, United Pharmaceuticals and Novalac. For the remaining authors, there is no conflict of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"238"}}