Inflammatory Bowel Diseases Clinical Trial
Official title:
Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease
Iron deficiency anemia is the most common systemic manifestation of Inflammatory Bowel Diseases (IBD)-Crohn's disease and ulcerative colitis. Iron deficiency with or without anemia poses a diagnostic and therapeutic challenge due to chronic gastrointestinal blood loss and the inflammatory nature of IBD. Recent illumination of iron metabolism has brought attention to the systemic iron regulator-hepcidin, a peptide hormone that regulates intestinal iron absorption and systemic iron availability. Elevated hepcidin is associated with oral iron malabsorption in IBD. This study aims to evaluate whether hepcidin concentration at baseline can predict response to oral and intravenous iron therapy in patients with IBD and concomitant iron deficiency with or without anemia.
The PRIme is a multicenter and randomized study that aims to evaluate the capacity of hepcidin at baseline to predict response to oral or intravenous iron therapy in patients with active IBD. Study participants will be randomized and allocated (open-label) to one of the three study arms: intravenous iron therapy, therapy with oral ferrous fumarate, or therapy with oral ferric maltol. During the study, biochemical indices such as hemoglobin, iron status, hepcidin and related cytokines will be measured at week 6, 14, and 24 after the start of the therapy. In addition, the study will evaluate changes in oxidative stress, quality of live, and productivity. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04046913 -
The ADDapt Diet in Reducing Crohn's Disease Inflammation
|
N/A | |
Active, not recruiting |
NCT04989907 -
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
|
||
Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
Active, not recruiting |
NCT04990258 -
A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
|
||
Completed |
NCT06216223 -
Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients
|
N/A | |
Enrolling by invitation |
NCT06015789 -
Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
|
||
Recruiting |
NCT06065995 -
StoMakker Mobile Application
|
N/A | |
Recruiting |
NCT03282786 -
Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease
|
N/A | |
Recruiting |
NCT06002074 -
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
|
N/A | |
Recruiting |
NCT04960826 -
Study of an Environmental Risk Factor in Crohn's Disease
|
||
Recruiting |
NCT05413941 -
Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease
|
N/A | |
Completed |
NCT03668249 -
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
|
||
Completed |
NCT00721812 -
A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686
|
Phase 1 | |
Recruiting |
NCT05809999 -
IBD Neoplasia Surveillance RCT
|
N/A | |
Recruiting |
NCT04138225 -
The Ecological Role of Yeasts in the Human Gut
|
||
Recruiting |
NCT04991324 -
Cholecalciferol Comedication in IBD - the 5C-study
|
Phase 3 | |
Completed |
NCT03173144 -
Chronic Inflammatory Disease, Lifestyle and Treatment Response
|
||
Not yet recruiting |
NCT05043818 -
A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
|
||
Recruiting |
NCT03042091 -
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
|
Early Phase 1 | |
Completed |
NCT02874365 -
Intestinal Stem Cells Characterization
|
N/A |