Cure8 research brief
If therapies that restore intestinal barrier function can be reliably tested and measured, future treatments might be developed that specifically target barrier healing — a mechanism linked to symptom relief and possibly better long-term outcomes for people with IBD.
Clinicians running or designing IBD clinical trials, researchers studying intestinal barrier biology or biomarker development, and regulators or funders shaping trial standards.
An international panel of 12 experts used a modified Delphi process to create consensus recommendations for designing clinical trials that evaluate therapies targeting the intestinal barrier in IBD.
Fourteen statements reached consensus covering whether and how barrier assessment should be used as an endpoint, timing of reassessment, protocol requirements, and disease-specific considerations.
The recommendations also address which assessment tools to prioritise and standardise, including imaging techniques, functional permeability assays, and endogenous biomarkers, plus implementation issues and areas for future research.
This report provides a structured framework to guide future trials but does not present results from trials of barrier-restoring therapies; rather it offers standardized design and measurement guidance grounded in expert agreement and literature review.
This item is an international expert consensus reported in Gut based on systematic review and Delphi voting. It provides design and measurement recommendations but not clinical trial results; practical uptake will depend on future studies adopting these standards.
Review the original publication for the complete reporting, methods, and context.
Conflict statement: Competing interests: SV received speaker’s fees from AbbVie, Celltrion, Ferring, Janssen, Takeda and support travel from AbbVie, Celltrion, Ferring, Galapagos, Janssen, Eli Lilly, Pfizer, Takeda and ThirtyfiveBio. RA: Abbvie, Abivax, AlfaSigma, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, CED Service GmbH, Celltrion Healthcare, Falk Foundation, Galapagos, Gilead, GSK plc., Gut Inc., InDex Pharmaceuticals, Johnson & Johnson, Eli Lilly, MSD Sharp & Dohme, Pfizer, Pandion Therapeutics, Roche Pharma, Takeda Pharma, Viatris. AB: lecture fees from AbbVie, Takeda, Janssen, Alfasigma, Pfizer, GSK, Giuliani. JC has no conflicts of interest related to this manuscript. SC has no conflicts of interest related to this manuscript. SD declares consultancy/advisory fees from AbbVie, Allergan, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Ferring Pharmaceuticals, Gilead Sciences, Hospira, Janssen, Johnson & Johnson, MSD, Mundipharma, Pfizer Inc, Roche, Sandoz, Takeda, TiGenix, UCB and Vifor; lecture/speaker fees from AbbVie, Amgen, Ferring Pharmaceuticals, Gilead Sciences, Janssen, Mylan, Pfizer Inc. and Takeda; and has directorship/ownership interests in Gastroenterology and Endoscopy. MF received speaker and/or consulting fees from Eli Lilly, OnoPharma, Quell Therapeutics and Foghorn and grant support from Eli Lilly. SG has received research grants from Eli Lilly and Company; served on steering committees for AbbVie and Bristol Myers Squibb; and received consulting fees from AbbVie, Celltrion, Ferring Pharmaceuticals, Galapagos NV, Janssen, Pfizer and Takeda. MI received grant research support from the Helmsley charitable trust, Eli Lilly and Olympus and speaker fees from Pentax, Pfizer, Eli Lilly and Janssen. VJ has received consulting/advisory board fees from AbbVie, Alimentiv, Asieris, Astra Zeneca, Biomebank, Boehringer Ingelheim, Caldera Therapeutics, Calluna, Celltrion, Domain Therapeutics, Eli Lilly, Enthera, Ensho, Exeliom Biosciences, Ferring Ventures, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Granite Bio, Janssen, Merck, Metacrine, Mountainfield, MRM Health, Nxera, Organon, OSE Immunotherapeutics, Pandion, Pendopharm, Pfizer, Prometheus Biosciences, Roche, Salvina, Sanofi, Shattuck Labs, Sorriso, Spyre, Synedgen, Takeda, Teva, Thabor Therapeutics, Union Therapeutics, Ventus, Ventyx, Vividion, Xencor and Zealand and pharma speaker’s fees from AbbVie, Ferring, Eli Lilly, Fresenius Kabi, Janssen, Pfizer, Takeda and Tillotts. RL declares advisory board membership from AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences and Takeda and research grant recipient from Joanna Tiddy University of Sydney, McKusker Charitable Foundation, Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer and Medical Research Future Fund Australia. MFN has served as advisor or speaker for Pentax, Roche Pharma, Takeda Pharma, Pfizer, MSD, PPM, Janssen, Gilead, Dr Falk Pharma, Boehringer Ingelheim, Amgen and AbbVie. NP has no conflicts of interest related to this manuscript. MP has no conflicts of interest related to this manuscript. TR received consultant fees from Takeda Pharma GmbH, Eli Lilly, Olympus Medical, Pentax Medical and Mauna Kea Technologies and speaking fees from Olympus Medical, Pentax Medical, Mauna Kea Technologies, Medtronic, Takeda, Galapagos, Falk, Janssen, AbbVie, Repha, Medical Tribune, Eli Lilly and Janssen. PR received consultancy fees from AbbVie, Celltrion, Johnson and Johnson and Takeda; ST grants/research support from AbbVie, Celgene, Celsius, ECCO, Galapagos, GSK, Helmsley Trust, IOIBD, Janssen, Eli Lilly, Pfizer, Takeda, UKIERI, 35Bio, Vifor and Norman Collisson Foundation; consulting fees from Alimentiv, Apexian, Apollo, Arcturis, AstraZeneca, BMS, Clario, Cosmo, Dova Health, Endpoint Health, EQrX, Equillium, Ferring, Galapagos, Genentech/Roche, Gilead, GSK, Janssen, Iterative Health, Eli Lilly, Mestag, Microbiotica, ONO, Pfizer, Phesi, Protagonist, Sanofi, Satisfai, Sensyne Health, Spyre, Takeda, Teva, Theravance and Tr1X Bio; speaker fees from BMS, Ferring, GSK, Janssen, Eli Lilly, Pfizer, Sun Pharma and Takeda; and share options from Dova Health Inc. SZ received consultant fees from AbbVie Deutschland GmbH & Co KG, Amgen GmbH, Biogen GmbH, Bristol-Myers Squibb GmbH & Co KG, Celgene GmbH, Celltrion Healthcare, Ferring Arzneimittel GmbH, Galapagos Biopharma Germany GmbH, Hogg Robinson GmbH, Janssen Pharmaceutica NV, Janssen Cilag GmbH, MICE Service GmbH, Mylan, Pfizer Pharma GmbH, Takeda Pharma GmbH. Speaker fees: AbbVie Deutschland GmbH & Co KG, Amgen GmbH, Biogen GmbH, Bristol-Myers Squibb GmbH & Co KG, CED Service GmbH, Falk Foundation e.V., Ferring Arzneimittel GmbH, FORGA Solutions GmbH, GWT-TUD GmbH, Janssen Cilag GmbH, Janssen Pharmaceutica NV, MSD Sharp & Dome, Roche, Pfizer Pharma GmbH, Pharma Zentrale GmbH, Takeda Pharma GmbH and WebMD Global. JW has no conflicts of interest related to this manuscript. LP-B declares consulting fees from AbbVie, Abivax, Adacyte, Alimentiv, Alfasigma, Amgen, Apini, Banook, BMS, Celltrion, Enthera, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, GSK, Hemay, Iterative Health, Janssen, Eli Lilly, LifeMine, Medac, Mirador, Morphic, MSD, Nordic Pharma, Novartis, Oddifact, Oncodesign Precision Medicine, Onco3RONO Pharma, OSE Immunotherapeutics, Palisade Bio, Par'Immune, Pfizer, Prometheus, Roche, Roivant, Samsung, Sandoz, Sanofi, Sorriso, Spyre, Takeda, Teva, ThirtyfiveBio, Tillots, Vectivbio, Vedanta and Ventyx; stock options from Iterative Health, Oragen, Pharmanest and Thetis; and lecture/speaker fees from AbbVie, Alfasigma, Amgen, Biogen, Celltrion, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead, Iterative Health, Janssen, Eli Lilly, Medac, MSD, Nordic Pharma, Novartis, Pfizer, Roche, Sandoz, Takeda and Tillots.
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