Clinical trials: Inflammatory Bowel Disease (IBD)
Inflammatory Bowel Diseases, Colitis, Ulcerative
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- VEDO TDM RWE (NCT04567628)
- Testing
- No Intervention
- Where
- Canada
- Volunteers
- 7,873 people
- Sponsor
- Takeda
Colitis, Ulcerative
COlonic Salvage by Therapeutic Appendectomy.
Rationale: The annual incidence of ulcerative colitis (UC) amounts to 6-8 new cases per 100.000. Patients are initially treated medically, and colitis refractory to medical management is treated surgically, mostly by means of an…
- Trial name
- COSTA (NCT03912714)
- Testing
- Laparoscopic appendectomy, Endoscopic appendix biopsies
- Where
- Netherlands
- Volunteers
- 123 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Mild-to-moderate Ulcerative Colitis
Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)
The purpose of this study is to provide evidence that a therapy of Ulcerative Colitis (UC) disease adjusted on tight monitoring of non-invasive parameters, such as clinical symptoms and faecal calprotectin (FC) (substance that is…
- Trial name
- OPTIMISE (NCT04340895)
- Testing
- Faecal Calprotectin Home Test, PRO-2 Scoring
- Where
- 42 sites in Czechia, Hungary and 4 more
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals
Inflammatory Bowel Disease (IBD), Crohn's Disease (CD)
Faecal Calprotectin as a Potential Non-invasive Inflammatory Marker in Pregnancy and Inflammatory Bowel Disease
When women with rheumatoid arthritis become pregnant 75% of them will go into remission, despite stopping medication. This phenomenon is not well understood and is not seen in other inflammatory conditions.
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn's Disease (CD), Ulcerative Colitis (UC), Pregnancy
- Trial name
- PREGCAL (NCT02778464)
- Where
- United Kingdom
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
Ulcerative Colitis
Exploratory Clinical Trial of Safety and Efficacy of Sacral Nerve Stimulation in Patients With Ulcerative Colitis.
Although the incidence of inflammatory bowel disease is stable in North American and European countries, the incidence of inflammatory bowel disease is increasing in newly industrialized countries, especially in China.
- Trial name
- NCT05895981
- Testing
- G132 system, Beijing PINS Medical Co., China
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Xijing Hospital
Inflammatory Bowel Diseases
Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease
For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD…
- Trial name
- NCT06342011
- Testing
- Anti-inflammatory diet group
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Crohn's Disease
Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease
This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.
- Trial name
- NCT03870334
- Testing
- BT-11 880 mg
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- NImmune Biopharma
Inflammatory Bowel Disease
Comparison of Surveillance Colonoscopy Techniques in Patients With IBD
We propose a randomized controlled study to determine the detection rates of neoplasia with high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High definition iSCAN virtual chromoendoscopy in…
- Trial name
- NCT02098798
- Testing
- HD Colonoscopy, HD Colonoscopy + iSCAN, HD Colonoscopy + dye spray
- Where
- Canada
- Volunteers
- 270 people
- Sponsor
- University of Calgary
Alopecia Areata, Depressive Episode
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
This study series consists of four related studies and aims to explore and describe many important elements of alopecia areata over three key areas: (1) the current epidemiology of alopecia areata, (2) the prevalence and…
- Conditions
- Alopecia Areata, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders
- Trial name
- NCT04239521
- Testing
- Exposure of interest (studies 2 & 3).
- Where
- United Kingdom
- Volunteers
- 51,955 people
- Sponsor
- Momentum Data
Ulcerative Colitis, Diet Habit
Micronutrient and Additive Modifications May Optimize Diet To Health
This is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the E 400-group with…
- Conditions
- Ulcerative Colitis, Diet Habit, Microbial Colonization
- Trial name
- Mammoth (NCT05743374)
- Testing
- Normal diet, E400 elimination
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Region Skane
Ulcerative Colitis
Indigo Carmine Staining and Narrow Band Imaging (NBI) of Colonic Mucosa for Detection of Dysplasia in Ulcerative Colitis
A prospective, randomized trial to determine indigo carmine dye spraying and narrow band imaging (NBI) of colonic mucosa to detect dysplasia in ulcerative colitis (UC).
- Trial name
- NCT00961948
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Mayo Clinic
Crohn Disease
Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
Primary outcome measure: Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred…
- Trial name
- NCT01157650
- Testing
- Autologous mesenchymal stem cells
- Where
- 3 sites in Spain
- Volunteers
- 15 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
Inflammatory Bowel Diseases, Remission
Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)
The investigators have designed a guided, online, tri-component, stress reduction intervention for participants with inflammatory bowel diseases.
- Conditions
- Inflammatory Bowel Diseases, Remission, Perceived Stress
- Trial name
- NCT03831750
- Testing
- Stress Reduction Intervention
- Where
- Canada
- Volunteers
- 101 people
- Sponsor
- University of Alberta
Colitis, Ulcerative
Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis.
The purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.
- Trial name
- NCT00151944
- Testing
- SPD476 (mesalazine)
- Volunteers
- 400 people
- Sponsor
- Shire
Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration…
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease
- Trial name
- CRADLE (NCT02154425)
- Testing
- Breast milk sampling, Certolizumab Pegol
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 17 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Ulcerative Colitis
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in…
- Trial name
- NCT00347048
- Testing
- tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
Colitis, Ulcerative
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with…
- Trial name
- NCT01900574
- Testing
- Golimumab
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease, Ulcerative Colitis
Expanded Access to Upadacitinib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Crohn Disease, Ulcerative Colitis, Idiopathic Arthritis (Including sJIA, pJIA, or JPsA), Atopic Dermatitis
- Trial name
- NCT04159597
- Testing
- Upadacitinib
- Sponsor
- AbbVie
Crohn Disease
Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.
- Trial name
- FMT (NCT05321758)
- Testing
- Fecal Microbiota Transplantation, Immunosuppressive Agents
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Tongji Hospital
Colitis, Ulcerative
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative…
- Trial name
- NCT00503243
- Testing
- Delayed and extended release mesalazine
- Where
- United States
- Volunteers
- 280 people
- Sponsor
- Shire
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