Probiotic rectal enema in ulcerative colitis
Phase 3
Recruiting
- Conditions
- ulcerative colitis.Ulcerative colitis
- Registration Number
- IRCT20130514013321N3
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber 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 Outcome Measures
Name Time Method 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).