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. 2024 Nov 4;30(11):2037-2045.
doi: 10.1093/ibd/izad293.

Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease

Sudheer K Vuyyuru  1 , Christopher Ma  2   3 , Tanmay Sharma  1 , Tran M Nguyen  4 , Talat Bessissow  5 , Neeraj Narula  6 , Siddharth Singh  7 , Florian Rieder  8   9 , Vipul Jairath  1   4   10
Affiliations

Characteristics of Interventional Trials for Patients Living With Intestinal Stoma Registered in ClinicalTrials.gov With a Focus on Inflammatory Bowel Disease

Sudheer K Vuyyuru et al. Inflamm Bowel Dis. .

Abstract

Background: This systematic review was performed to characterize the landscape of research conducted in patients with intestinal stoma (IS) and highlight unmet needs for clinical research in Crohn's disease (CD) and IS.

Methods: We searched ClinicalTrials.gov from inception to May 25, 2022, to identify clinical trials assessing interventions in patients with an IS, as well as those with an IS and CD. Studies were grouped according to type of intervention. We excluded observational studies with no treatment arm.

Results: A total of 253 studies were included in the final analysis. Most studies investigated devices (n = 122 [48.2%]), or surgical procedures (n = 63 [24.9%]), followed by behavioral interventions (n = 30 [11.8%]), drugs (n = 20 [7.9%]), dietary interventions (n = 2 [0.8%]), skin care products (n = 2 0.8%]), and others (n = 14 [5.5%]). A total of 50.9% (n = 129) of studies had completed recruitment, enrolling 11 116 participants. Only 6 studies (surgery: n = 3; physiological studies: n = 2; drugs: n = 1) exclusively included patients with inflammatory bowel disease (IBD), and 16 studies commented that patients with IBD were excluded in their eligibility criteria. No study assessed efficacy of drugs in patients with CD and IS. Approximately one-quarter of studies (n = 65 of 253) included quality of life as an outcome measure.

Conclusion: There is a paucity of research in IBD patients with IS, with the majority focusing on devices and surgical procedures. There have been no drug trials evaluating efficacy in patients with CD and IS. There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures that enable the inclusion of patients with CD with stoma into clinical trials.

Keywords: Crohn’s; ileostomy; intestinal stoma; ulcerative colitis.

Plain language summary

We analyzed registered trials for patients with intestinal stoma with special focus on Crohn’s disease patients to explore research and unmet needs. Our results indicate a scarcity of studies in this area with most studies limited to surgical procedures and devices.

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Conflict of interest statement

C.M. has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pendopharm, Pfizer, Roche, and Sanofi; speaker fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, Takeda, Pendopharm, and Pfizer; royalties from Springer Publishing; and research support from Ferring, Takeda, and Pfizer. T.B. has served as a speaker or advisor for AbbVie, Alimentiv (formerly Robarts Inc), Amgen, Bristol Myers Squibb, Eli Lilly, Ferring, Fresenius Kabi, Gilead, Iterative Scopes, Janssen, Pendopharm, Merck, Pentax, Pfizer, Roche, Sandoz, Takeda, and Viatris. N.N. has served as a speaker or advisor for Janssen, AbbVie, Takeda, Pfizer, Merck, Sandoz, Fresenius Kabi, Innomar, Iterative Scopes, Bristol Myers Squibb, Viatris and Ferring. S.S. has received institutional research support from Pfizer and AbbVie (in the last 24 months); and personal fees from Pfizer for ad hoc grant review. F.R. has served as a consultant for Adnovate, Agomab, Allergan, AbbVie, Arena, Boehringer Ingelheim, Celgene/BMS, CDISC, Celsius, Cowen, Ferring, Galapagos, Galmed, Genentech, Gilead, Gossamer, Guidepoint, Helmsley, Horizon Therapeutics, Image Analysis Limited, Index Pharma, Janssen, Koutif, Mestag, Metacrine, Mopac, Morphic, Organovo, Origo, Pfizer, Pliant, Prometheus Biosciences, Receptos, RedX, Roche, Samsung, Surmodics, Surrozen, Takeda, Techlab, Theravance, Thetis, UCB, Ysios, and 89Bio. V.J. has received has received consulting/advisory board fees from AbbVie, Alimentiv Inc, Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Reistone Biopharma, Roche, Sandoz, Second Genome, Takeda, Teva, Topivert, Ventyx, and Vividion; and speaker fees from AbbVie, Ferring, Galapagos, Janssen Pfizer Shire, Takeda, and Fresenius Kabi. The other authors disclose no conflicts.

Figures

Figure 1.
Figure 1.
Pie chart showing geographical distribution of registered interventional studies.
Figure 2.
Figure 2.
Pie chart showing disease distribution of included studies.
Figure 3.
Figure 3.
Graph showing temporal trend of registered interventional studies of patients with intestinal stoma.
See this image and copyright information in PMC

References

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