A double blind, randomized, placebo controlled trial to investigate the effect of VSL#3 in the metabolic profile of colonic mucosa in patients with ulcerative colitis in remission using 1H magnetic resonance spectroscopy
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Difference in metabolic profile in the colonic biopsies of patients with ulcerative colitis before and after 8 weeks of drug administration
研究概览
简要总结
This is a double blind, randomized, placebo controlled trial to investigate the effect of VSL#3 in the metabolic profile of colonic mucosa in patients with ulcerative colitis in remission using 1H magnetic resonance spectroscopy. Probiotic, VSL#3, has been found to be effective both in induction and maintenance of UC, improving the clinical symptoms and normalizing the colonic mucosa, as proved from a number of published clinical studies. This study is designed to see if addition of VSL#3 to the conventional regimen acts by improving the metabolic profile (as analyzed by magnetic resonance spectroscopy of the colonic biopsies) of the colonic mucosa in UC remission patients. Research question: Does addition of VSL#3 to mesalamine improve the metabolic profile in the colonic mucosa of ulcerative colitis patients in remission and this forms the primary objective of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Difference in metabolic profile in the colonic biopsies of patients with ulcerative colitis before and after 8 weeks of drug administration
时间窗: Difference in metabolic profile in the colonic biopsies of patients with ulcerative colitis before and after 8 weeks of drug administration
次要结局
- Difference in metabolic profile in the urine of patients with ulcerative colitis before and after 8 weeks of drug administration(8 weeks)