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Recruiting
NCT07758335
The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients the Patient Will be Recruited From Outpatient Clinic of IBD and Gastroenterology of the National Hepatology and Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.
Conditions: To Evaluate the Efficacy of Lactobacillus Probiotics When Added to UC Standard of Care in Maintaining Remission in UC Patients
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 132
Sponsor: National Hepatology & Tropical Medicine Research Institute
Location: NHTMRI(national hepatology and tropical medicine research institute) Cairo
Summary
the goal of this interventional observational study is to To evaluate the efficacy , safety of lactobacillus probiotics or trace elements when added to UC standard of care in maintaining remission in UC patients and to To compare the efficacy of adding lactobacillus probiotics versus adding trace elements to UC standard of care 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. Study group 1 Forty-four patients will receive 20 billion colony forming unit (CFU) of Lactobacillus acidophilus for six months together with IBD standard of care (biological therapy e.g., infliximab in a dose of 5mg/kg ) Group II. Study group 2 Forty-four patients will receive 1 tablet twice daily of trace elements (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) as Vitayami® together with the IBD standard of care biological therapy e.g., infliximab in a dose of 5mg/kg) Group III. Control group Forty-four Patients will be receiving the UC standard of care (biological therapy e.g., infliximab in a dose of 5mg/kg) according to the hospital protocol without receiving lactobacillus or trace elements.
Primary outcome The decline in the inflammatory bowel disease activity index to less than 50% compared to baseline.
Secondary outcome The improvement in mucosal healing measured by colonoscopy compared to baseline.
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).
Source: ClinicalTrials.gov (NCT07758335). StuddyBuddy aggregates publicly available trial information.