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
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 ).
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.
Parallel
Lactobacillus acidophilus will be assigned for arm 1
Druglacteole forte capsules contains 20 billion colony forming unit (CFU) of Lactobacillus acidophilus
trace elements
Drugeach vitayami capsule contain (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)
Control Arm - standard of care
Other interventioncontrol arm contain no drug only standard of care
The decline in the inflammatory bowel disease activity index to less than 50% compared to baseline.
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
The improvement in mucosal healing measured by colonoscopy compared to baseline
The secondary outcome will be the improvement in mucosal healing measured by colonoscopy at week 24 of study period compared to baseline (week 0). Safety Assessment
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