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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.

NCT07758335 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • To Evaluate the Efficacy of Lactobacillus Probiotics When Added to UC Standard of Care in Maintaining Remission in UC Patients

Interventions

DRUG

Lactobacillus acidophilus will be assigned for arm 1

lacteole forte capsules contains 20 billion colony forming unit (CFU) of Lactobacillus acidophilus

DRUG

trace elements

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)

OTHER

Control Arm - standard of care

control arm contain no drug only standard of care

Sponsors & Collaborators

  • National Hepatology & Tropical Medicine Research Institute

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-02
Primary Completion
2027-03-01
Completion
2027-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758335 on ClinicalTrials.gov