Effects of Adalimumab in Iranian Pediatric with Inflammatory Bowel Disease

Phase 3

Recruiting

Conditions: Inflammatory bowel disease.
Inflammatory polyps of colon with intestinal obstruction
K51.412

Registration Number: IRCT20220409054467N3

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 25

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.