Inflammatory bowel disease
Conditions
Interventions
Intervention group :iron isomaltoside
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 60 years old. 2. The subject is newly diagnosed with IBD and IDA between January 1, 2023 and December 31, 2024. The diagnosis of IBD is in accordance with "The consensus on diagnosis and treatment of inflammatory bowel diseases in 2018"; The diagnosis of IDA is in accordance with following criterion: a) Hb<13g/dL for male, Hb<12g/dL for female; b) Serum ferritin<100ug/L. 3. The subject plans to accept anti-TNF-a monoclonal antibody treatment. 4. The subject volunteers to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Ambiguous or changed diagnosis during follow-up. 2. The subject has diseases that may also cause anemia, such as autoimmune disease, blood disease, urinary disease, digestive disease, tumor, or surgery within 8 weeks. 3. The subject has diseases with iron overload or impaired iron utilization (e.g., hemochromatosis). 4. The subject has allergy to infliximab or iron isomaltoside. 5. The subject has a planned surgery with excessive blood loss during the study. 6. The subject who has participated in any other clinical studies within 3 months before enrollment. 7. The subject is considered as disadvantaged groups, including subjects who are critically ill, who have psychiatric disorders or cognitive impairment, or who are pregnant or juveniles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic improvement rate;Endoscopic remission rate;Clinical response rate;Clinical remission rate;Enhanced clinical response rate;Mucosal healing; | — |
Countries
China
Contacts
Public ContactQian Cao
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed