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
Phase 4 · Testing Lactobacillus acidophilus will be assigned for arm 1, trace elements and Control Arm -… · 1 site · National Hepatology & Tropical Medicine Research Institute
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Lactobacillus acidophilus will be assigned for arm 1 (a drug), trace elements (a drug) and Control Arm - standard of care as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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 ).
There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 132 participants are expected to take part.
- Start date: 2025-07-02.
- Main results expected around 2027-03-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Egypt.
Main thing being measured
- The decline in the inflammatory bowel disease activity index to less than 50% compared to baseline. (24 weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | National Hepatology & Tropical Medicine Research Institute |
| Enrollment | 132 (estimated) |
| Start date | 2025-07-02 |
| Primary completion (est.) | 2027-03-01 |
| First posted | 2026-08-11 |
| Last updated | 2026-09-16 |
| Official title | The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients |
| ClinicalTrials.gov ID | NCT07758335 |
Interventions
- Lactobacillus acidophilus will be assigned for arm 1 (Drug)
lacteole forte capsules contains 20 billion colony forming unit (CFU) of Lactobacillus acidophilus - trace elements (Drug)
each 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)
control arm contain no drug only standard of care
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| NHTMRI(national hepatology and tropical medicine research institute) | Cairo | Egypt | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.