The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The decline in the inflammatory bowel disease activity index to less than 50% compared to baseline.
研究概览
简要总结
the goal of this interventional observational study is to To evaluate the efficacy , safety of lactobacillus probiotics or trace elements when added to (ulcerative colitis) infliximab in maintaining remission in UC patients and to To compare the efficacy of adding lactobacillus probiotics versus adding trace elements to infliximab This study will be open label, parallel, prospective interventional study which will be conducted in the outpatient clinic of IBD and gastroenterology of the National Hepatology and tropical medicine research institute (NHTMRI), Cairo, Egypt.
The recruited patients will be randomly allocated in one of three groups:
Group I. will receive 20 billion colony forming unit (CFU) of Lactobacillus acidophilus for six months together with infliximab Group II. Study group 2 will receive 1 tablet twice daily of trace elements as Vitayami together infliximab fpr six months Group III. Control group will receive infliximab only Primary outcome The decline in the mayo score to less than 50% after six months compared to baseline.
Secondary outcome The improvement in mucosal healing after six months of intervention measured by colonoscopy compared to baseline.
physical examination will be done at the baseline then every 2 weeks of the study lab tests will be performed at base line then every 3 months intestinal ultrasound , Colonoscope will be done twice at the beginning and at the end of trial the patients also will be asked to report any adverse events every 2 weeks quality of life of patients will be assed 3 times during trial by Short Irritable Bowel Disease Questionnaire (SIBDQ) , food frequency questionnaire will be done once at the beginning of the study
详细描述
Objectives
- To evaluate the efficacy of lactobacillus probiotics when added to UC standard of care in maintaining remission in UC patients.
- To evaluate efficacy of trace elements when added to UC standard of care in maintaining remission in UC patients.
- To compare the efficacy of adding lactobacillus probiotics versus adding trace elements to UC standard of care.
- To evaluate safety of lactobacillus probiotics and trace elements when added to UC standard of care in maintaining remission in UC patients.
Methodology Inclusion criteria
1. Age 18-65 years. 2. Patients diagnosed with mild to moderate UC (according to Mayo Score (36) for Ulcerative Colitis).
3. Patients are on standard of care (biological therapy e.g., infliximab ). Exclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •Patients diagnosed with mild to moderate UC (according to Mayo Score (36) for Ulcerative Colitis).
- •Patients are on standard of care (biological therapy e.g., infliximab ).
排除标准
- •Patients with neurological problems including Alzheimer disease and other dementias, multiple sclerosis, Parkinson's disease, history of large stroke, severe psychiatric disease as it may affect their ability to adhere to their medication and the clinical trial rules and their ability to perform the tests and questionnaires involved in the study (37).
- •Patients with communication problems, that can affect their ability to fully understand the purpose of the trial, difficulty in communicating by phone or ability to come in scheduled visits (38).
- •Patients with autoimmune diseases.
- •Patients with colorectal cancer.
- •Patients previously received probiotics or trace elements in the previous month before recruitment.
- •Liver cirrhosis.
- •Chronic kidney disease (CKD) which is defined as an estimated glomerular filtration rate (eGFR) less than 60 ml/min per 1.73 m2, persisting for 3 months or more (39).
- •Pregnancy or Lactation (40)
- •Patients on conventional therapy (5-amino salicylic acid treatment).
研究组 & 干预措施
arm 1 : lactobacillus acidophilus
arm 1 : will receive Lactobacillus acidophilus 20 billion colony forming unit (CFU) of Lactobacillus acidophilus (1 capsule of 10 billion CFU twice daily) for six months
干预措施: Lactobacillus acidophilus will be assigned for arm 1 (Drug)
Arm 3 (control)
will receive infliximab only , no lactobacillous or trace elements no intervention drug
干预措施: Control Arm - standard of care (Other)
arm 2: Vitayami caps
44 patients included will receive 1 tablet twice daily of vitayami caps which is a trace elements contains (zinc 15 mg, chromium 15 mcg, selenium 15 mcg, copper 1000 mcg, iodine 75 mcg, iron 30 mg, magnesium 2.5 mg, molybdenum 15 mcg) with infliximab in a dose of 5mg/kg) for six months
干预措施: trace elements (Drug)
结局指标
主要结局
The decline in the inflammatory bowel disease activity index to less than 50% compared to baseline.
时间窗: 6 months
the Mayo Scoring System for Assessment of Ulcerative Colitis Activity will be assessed at baseline and at the end of treatment (week 24) where decline in Mayo score to less than 50% compared to baseline will be considered as the primary outcome
The decline in the inflammatory bowel disease activity index to less than 50% compared to baseline.
时间窗: 24 weeks
the Mayo endoscopic Scoring System for Assessment of Ulcerative Colitis Activity will be assessed at baseline and at the end of treatment (week 24) The score can range from 0-12 with higher scores indicating worse severity.the decline in Mayo score to less than 50% compared to baseline will be considered as the primary outcome
次要结局
- The improvement in mucosal healing measured by colonoscopy compared to baseline(24 weeks)
研究者
Mai Abd el moneim
Clinical Pharmacist at National Hepatology and Tropical Medicine Research Institute (NHTMRI)
National Hepatology & Tropical Medicine Research Institute