Probiotics and Trace Elements Added to Infliximab in Ulcerative Colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, parallel, prospective interventional study enrolling adults with mild-to-moderate UC who are receiving infliximab. Participants are randomized into three groups: Lactobacillus acidophilus plus infliximab, trace elements plus infliximab, or infliximab alone. The study lasts six months and aims to compare the ability of the probiotic versus trace elements to maintain remission, as well as to evaluate safety. Outcomes focus on remission maintenance measured by standard UC assessments and safety signals. Recruitment is from the outpatient clinic of the National Hepatology and Tropical Medicine Research Institute in Cairo, Egypt.

Why it matters

Who can join: the full rules

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).

Where it's running

• NHTMRI(national hepatology and tropical medicine research institute)
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Mai Abd el moneim, Msc of clinical pharmacy
• Email: monem_mai@yahoo.com
• Phone: +201151355664

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.