NCT07758335 The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients the Patients Will be Recruited From Outpatient Clinic of Inflammatory Bowel Disease (IBD) of the National Hepatology and Tropical Medicine Research Institute NHTMRI, Cairo, Egypt

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 132 participants in total. It began in 2025-07-02 with a primary completion date of 2027-03-01.

Brief Summary

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

Eligibility Criteria

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: 1. 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). 2. 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). 3. Patients with autoimmune diseases. 4. Patients with colorectal cancer. 5. Patients previously received probiotics or trace elements in the previous month before recruitment. 6. Liver cirrhosis. 7. 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). 8. Pregnancy or Lactation (40) 9. Patients on conventional therapy (5-amino salicylic acid treatment).

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