Inflammatory bowel disease. Inflammatory polyps of colon with intestinal obstruction
Conditions
Interventions
Intervention group: Administration of adalimumab (40 mg/0.8 ml) which is injected in patients weighing less than 40 kg based on the following dose: 80 mg first, 40 mg two weeks later, 20 mg two weeks
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: Willingness to cooperate and sign the informed consent form after full knowledge of the objectives and methods of the study. Girls and boys aged 2 to 18 years Diagnosis of IBD based on endoscopic, laboratory studies, and clinical examinations. Absences other diseases and chronic and acute liver disorders (hepatitis B, C, etc.), biliary disease, other gastrointestinal diseases, chronic diseases (including type one or two diabetes, cardiovascular, pulmonary and celiac disease), autoimmune diseases Known and inherited and metabolic disorders. No history of alcohol consumption or alcohol consumption more than 10 grams per day in women and more than 20 grams per day in men. No pregnancy or breastfeeding in women. No substance abuse, no chronic inflammatory disease, no history of cancer, no hormone therapy. Presence of perianal fistula. Active disease despite the administration of corticosteroids Failure to respond to immunomodulators
Exclusion criteria
Exclusion criteria: Having any acute illness The occurrence of any accident that affects a person's health. Use of antibiotics during the study Acceptance rate less than 80% Immigration Exclusion based on personal preference of participants or their parents Changes in medications taken during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity index. Timepoint: Beginning and end of the study. Method of measurement: Software for calculating pediatric Crohn's disease activity index (PCDAI) and pediatric ulcerative colitis activity index (PUCAI).;Fecal calprotectin level. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Weight. Timepoint: Beginning and end of the study. Method of measurement: scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum C-reactive protein (CRP) levels. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit.;Body mass index. Timepoint: Beginning and end of the study. Method of measurement: Calculation.;Serum Albumin. Timepoint: Beginning and end of the study. Method of measurement: Laboratory kit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactPejman Rohani
Tehran University of Medical Sciences
Outcome results
None listed