ulcerative colitis. Ulcerative colitis
Conditions
Interventions
Intervention 1: Intervention group: The investigational drug contains probiotic, non-pathogenic Bifidobacterium longum. (108 viable microorganisms per ml). Other components are purified water, sodium
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
4 Years to 20 Years
Inclusion criteria
Inclusion criteria: children at age of 4-20 definite diagnosis of ulcerative colitis by colonoscopy and histology with disease severity of mild to moderate at least 2 confirmed prior manifestations of the disease
Exclusion criteria
Exclusion criteria: Infectious colitis or other causes of colitis such as medical drugs, radiation, ischemia of affected intestinal segments Crohn's disease Participation in another clinical trial either simultaneously or within 30 days prior to enrolment a lack of cooperation, neurotic personality, and obesity A history of stool incontinence, perianal fistulae, major colonic surgery, colorectal carcinoma, or or stenosis Ill patients who are unable to cooperate & the patients suspicious to toxic megacolon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who are in clinical remission after the trial. Timepoint: ?At the begining of study, at the physician visits in weeks 2, 4 and 8 & patient self-reported questionnares in weeks 1,3,5,6 and 7. Method of measurement: Assessment of PUCAI by questionnaire (Clinical remission defined as PUCAI less than 10).;Number of patients who experience clinical response after the trial. Timepoint: ?At the physician visits on weeks 2, 4 and 8 & patient self-reported questionnares in weeks 1,3,5,6 and 7. Method of measurement: Assessment of PUCAI by questionnaire (Clinical response defined as changes in PUCAI more than or equal to 20 or achievement of clinical remission). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the level of stool calprotectin. Timepoint: At the physician visits in weeks 2, 4, and 8. Method of measurement: Stool sample.;Changes in the level of inflammatory factors (ESR, CRP). Timepoint: At the physician visits in weeks 2, 4, and 8. Method of measurement: Blood sample.;Extraintestinal manifestations. Timepoint: At the physician visits in weeks 2, 4, and 8. Method of measurement: Questionnaire.;Global health assessment by the physician. Timepoint: At the physician visits in weeks 1, 2, and 8. Method of measurement: questionnaire (6-point scale). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Ah?mad Gholami
Shiraz University of Medical Sciences
Outcome results
None listed