An observational study in Inflammatory Bowel Diseases and Primary Sclerosing Cholangitis, sponsored by University Hospital Birmingham NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Observational
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Among 112 studies in Inflammatory Bowel Diseases with a site in United Kingdom — 21 open to participants now, 28 under way, 6 of them phase 3. Inflammatory Bowel Diseases · United Kingdom.
Among the 112 studies in Inflammatory Bowel Diseases with a site in United Kingdom, this one is the 40th largest by planned enrollment of the 42 observational ones that give a count, is one of 6 that started in 2022, is one of 42 observational ones, and was the 89th registered.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 425 are open to participants now.
Browse Inflammatory Bowel Diseases studies →21 of the 112 studies in Inflammatory Bowel Diseases with a site in United Kingdom are open now. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United Kingdom
Ages 18–75
GlaxoSmithKline · Sites in United Kingdom
Ages 18–75
Janssen-Cilag Ltd. · Sites in United Kingdom
Ages 18+
Nutricia UK Ltd · Sites in United Kingdom
Ages 3+
Barts & The London NHS Trust · Sites in United Kingdom
Ages 16+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 277 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 117 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
112 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 13 · Phase 3 22 · Phase 4 4
First in 2006; this study’s year is marked. 6 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Median enrollment 95 across the 70 interventional studies, 215 across the 42 observational. Of the 67 that completed or were terminated, 26 (39%) have results posted.
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51 of 112 have an industry lead sponsor. The 10 most frequent:
University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
University Hospital Birmingham NHS Foundation Trust has 1 study filed under Inflammatory Bowel Diseases — fewer than ten, so there is no comparison to draw.
7 of the studies in Inflammatory Bowel Diseases with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05923073Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | 2027-10-27 |
| NCT06723418University of GlasgowDevelopment and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS) | 2026-12 |
| NCT06956703University of NottinghamNAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study | 2026-12-31 |
| NCT06877923Nutricia UK LtdElemental 028 Extra Case Studies | 2027-02 |
| NCT06286709University of BirminghamFAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis | 2027-09-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 112 studies in Inflammatory Bowel Diseases with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). Although rare, PSC is associated with significant and disproportionate unmet needs; with heightened risks of colorectal cancer and colectomy, and greater all-cause mortality rates compared to matched IBD patients. Unfortunately, no medical therapy has been proven to slow disease progression in PSC-IBD, and liver transplantation is the only lifesaving intervention for patients.
The strong association between PSC and IBD has led to several pathogenic hypotheses, in which dysregulated mucosal immune responses are proposed to contribute. Of note, the investigators recently identified distinct mucosal transcriptomic profiles in PSC-IBD; with regards bile acid metabolism, bile acid signalling, and a central role of enteric dysbiosis. In parallel, pilot data from other groups have shown that treatment with oral vancomycin (a non-absorbable, gut-specific antibiotic) attenuates colonic inflammation and improves biochemical markers of cholestasis in PSC. However, there is no mechanistic data exploring the host-microbial alterations under vancomycin treatment in PSC-IBD, neither the impact of vancomycin on bile acid circulation. The investigators of this study hypothesize that oral vancomycin attenuates colonic mucosal inflammation in PSC-IBD, by restoring gut microbiota mediated bile acid homeostatic pathways. Through these means the study aims to identify druggable gut microbial and host molecular pathways associated with bile acid mediated colonic mucosal inflammation in PSC-IBD.
Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). Although rare, PSC is associated with significant and disproportionate unmet needs; with heightened risks of colorectal cancer and colectomy, and greater all-cause mortality rates compared to age- and sex-matched IBD controls. Unfortunately, no medical therapy has been proven to slow disease progression in PSC-IBD, and liver transplantation is the only lifesaving intervention for patients. The strong association between PSC and IBD has led to several pathogenic hypotheses, in which dysregulated mucosal immune responses are proposed to contribute. Of note, the investigators of this study recently identified distinct mucosal transcriptomic profiles in PSC-IBD; with regards bile acid metabolism, bile acid signalling, and a central role of enteric dysbiosis. In parallel, pilot data from other groups have shown that treatment with oral vancomycin (a non-absorbable, gut-specific antibiotic) attenuates colonic inflammation and improves biochemical markers of cholestasis in PSC. However, there is no mechanistic data exploring the host-microbial alterations under vancomycin treatment in PSC-IBD, neither the impact of vancomycin on bile acid circulation.
In this study, fifteen PSC-IBD patients will be recruited through a large tertiary referral centre, who are undergoing lower gastrointestinal examination as per routine standard of care. Participants will be offered 4 weeks of treatment with oral vancomycin, and stool samples collected at different timepoints to evaluate changes in metagenomic, metatranscriptomic, and bile acid profiles. Colonic biopsies will be collected at baseline and at week 4 (flexible sigmoidoscopy) and subjected to FACS sorted RNA sequencing to identify changes in colonic epithelial cell pathways. Multi-omics data integration will be performed to uncover combinations of predictive profiles, model microbial networks, and host transcriptomic changes implicated in the response to oral vancomycin. This study will inform the downstream identification of specific host molecular and microbial pathways that has a potential for development of therapeutic targets for PSC-IBD in clinical practice.
15 patients with active PSC-IBD will undergo 4 weeks of treatment with open label (standard of care) oral vancomycin.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
As part of standard of care
Identify stool metagenomic, metatranscriptomic and bile acid profiles following treatment with oral vancomycin in PSC-IBD
Time frame: 12 months
Investigate changes in colonic mucosal epithelial bile acid and immunological pathways through FACS sorted RNA-sequencing following oral vancomycin
Time frame: 12 months
Identification of druggable host molecular and microbial targets through multi-omic integration analysis
Time frame: 12 months
Plan to share: Undecided
Started Feb 2022 (actual). Primary completion is estimated for Feb 2023, 12 months after the start.
Of 243 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 132. This study's planned 12 months is below that.
Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University Hospital Birmingham NHS Foundation Trust