Health Condition 1: null- Patients with ulcerative colitis in remission
Conditions
Interventions
Intervention1: VSL#3 Sachets, each sachet containing 900 Billion CFU: 1 sachet b.i.d. for 8 weeks
Control Intervention1: Placebo sachets: 1 sachet b.i.d. for 8 weeks
Sponsors
CD Pharma India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and Females; Age 18 to 80 yrs 2.Male or female patient who is voluntarily able to give informed consent 3.Diagnosis of ulcerative colitis established by previous endoscopy, with consistent histology and clinical course 4.At least one previous episode of colitis 5.Ulcerative colitis Activity: Patients must have a stool frequency score of 0, rectal bleeding score of 0 and mucosal appearance score of 0 or 1 (Ulcerative Colitis Disease Activity Index) 6.Current use of only oral 5-ASA compounds (Only Mesalamine), provided, the dose has been stable at 2400 mgs per day for at least 8 weeks prior to enrolment 7.Ability to give informed consent
Exclusion criteria
Exclusion criteria: 1.Evidence of abdominal abscess, toxic megacolon, any colectomy, ileostomy, colostomy at the initial screening visit 2.Chronic hepatitis B or C infection, any identified congenital or acquired immunodeficiency (HIV infection, organ transplantation) or any clinically significant extra-intestinal infection (e.g., pneumonia, pyelonephritis) within 30 days prior to enrolment 3.Female patients who are lactating or are known to be pregnant at the time of enrolment 4.Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety 5.Had any surgical procedure requiring general anaesthesia within 30 days prior to enrolment or is planning to undergo major surgery during the study period 6.Use of any topical treatment (rectal enemas/ suppositories) prior to 4 weeks of enrolment 7.Use of any probiotics in the last 6 weeks prior to enrolment 8.Use of antibiotics in the past 2 weeks prior to recruitment 9.History/ evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to enrolment 10.History or evidence of colonic mucosal dysplasia 11.Diagnosis of Crohns colitis, pouchitis, proctitis or indeterminate colitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in metabolic profile in the colonic biopsies of patients with ulcerative colitis before and after 8 weeks of drug administrationTimepoint: Difference in metabolic profile in the colonic biopsies of patients with ulcerative colitis before and after 8 weeks of drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in metabolic profile in the urine of patients with ulcerative colitis before and after 8 weeks of drug administrationTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Govind Makharia
AIIMS
Outcome results
None listed