Condition 1: Ulcerative Colitis. Condition 2: Ulcerative Colitis. Condition 3: Ulcerative Colitis. Chronic Ulcerative Proctitis Ulcerative (chronic) rectosigmoiditis Left sided colitis left hemicolitis
Conditions
Interventions
Intervention 1: Lacrocare (Zist Takhmir, Tehran, Iran)
Lactobacillus casei, lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum,
Treatment - Drugs
Lacrocare (Zist Takhmir, Tehran, Iran)
Lactobacillus casei, lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcous
Placebo, 500 mg Oral Capsule,containing: Maltodextrin, Lactose, Avicil, Magnesium Stearat, Talc. BID for 8 weeks.
Sponsors
Vice chancellor for research, Golestan University of Medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Main inclusion criteria: 1-Diagnosis of ulcerative colitis established by previous colonoscopy with consistent histology and clinical course; 2-Ulcerative colitis involving at least rectosigmoid region, activity confirmed by colonoscopy prior to the study; 3- Mild-to-moderate relapsing ulcerative colitis, defined as simple clinical colitis activity; 4- Relapsing episodes for less than 4 weeks before study entry; 5- Use of oral 5-aminosalicylic acid, at least 4 weeks before study at a stable dose (mesalazine at least 1.6 g/day) or 6-mercaptopurine (at least 1 mg/kg/day) at least 3 months before study entry at a stable dose. Main exclusion criteria: 1- Crohn's disease or pouchitis; 2- Severe ulcerative colitis according to simple clinical colitis activity index; 3- Use of oral steroids within the last 4 weeks before study entry; 4- Use of antibiotics within the last 2 weeks before study entry; 5- Change in dose of oral 5-aminosalicylic acid, within the last 4 weeks before study entry and within the 8-week study period or a change in dose of oral 6-mercaptopurine and azathioprine drugs within the last 3 months before the study 6- use of rectal 5-aminosalicylic acid, or steroids within 1 week before the study
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of probiotic's effect on improvement of bowel health in the patients with mild to moderate ulcerative colitis. Timepoint: during 8-week study. Method of measurement: Simple colitis activity index by questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNiloofar Rajabli
Golestan Research Center of Gastroenterology and Hepatology
Outcome results
None listed