Randomised clinical trial and meta-analysis: mesalazine treatment in irritable bowel syndrome-effects on gastrointestinal symptoms and rectal biomarkers of immune activity.

"Declaration of personal interests: VCT, LA, GL and JPH declare no conflict of interest. LÖ has served as Consultant/Advisory Board member for Genetic Analysis AS, has received unrestricted research grants from AstraZeneca and as a speaker for Takeda, AbbVie and Meda. BF has served as Consultant for BMS, AstraZeneca, Calliditas, Pharmalink, Astellas, ALEXION, CSL Behring, SANDOZ, has ownership interest in Calliditas (<1%), has received research funding from BMS, Pharmalink, Astellas, SANDOZ, CSL Behring, has received honoraria from BMS, NOVARTIS, Sandoz, Astrazeneca, Roche, Calliditas, ALEXION, and has personal pending patent and Advisory or Leadership Role: Calliditas, Astellas, ALEXION,CSL Behring, Sandoz, BioAnalogica AB, Transcutan AB, BioConcept AB. ØH has served as Consultant/Advisory Board member/speaker for Jansen‐Cilag. PV is the major owner of Diagnostics Development and owns worldwide patents of the immunoassay of human neutrophil lipocalin and phospholipase B‐precursor. MS has received unrestricted research grants from Glycom and Danone Nutricia Research and served as advisory board member/consultant and/or speaker for Biocodex Glycom, Danone Nutricia Research, Ironwood, Genetic Analysis AS, Kyowa Kirin, Menarini, Arena, Adnovate, Tillotts, Takeda, Alimentary Health, AlfaSigma, Falk Foundation and Shire. HT has served as a speaker for Biocodex, Takeda and Tillotts."

"FUNDING INFORMATION This study was funded by Eurostars project grant E!5691, an unrestricted grant from Tillotts Pharma AB (mesalazine (Asacol) and placebo), and by grants from the Swedish state under the agreement between the Swedish government and the county councils ALF‐agreement (ALFGBG 295071, 620,221, 726,561, 875,581)."

"The study was conducted in accordance with the Declaration of Helsinki. All aspects of the study had been approved by Swedish and Norwegian Regional Ethical Review Boards (2011/1793–31/2, 2013/2032) and Medical Products agencies (2011–003418‐18, 13/16072). The study was registered at ClinicalTrials.gov, identifier NCT01699438."