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

NCT07758335 | Recruiting Phase 4 DMC

• 1 other identifier: NHTMRI ,serial :7-2025
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Ulcerative Colitis (UC)

Keywords

ulcerative colitis remission trace elements lactobacillus

Outcome Measures

Primary Outcomes (1)

• The decline in the inflammatory bowel disease activity index to less than 50% compared to baseline.

  the Mayo endoscopic Scoring System for Assessment of Ulcerative Colitis Activity will be assessed at baseline and at the end of treatment (week 24) The score can range from 0-12 with higher scores indicating worse severity.the decline in Mayo score to less than 50% compared to baseline will be considered as the primary outcome

  24 weeks

Secondary Outcomes (1)

• The improvement in mucosal healing measured by colonoscopy compared to baseline

  24 weeks

Study Arms (3)

arm 1 : lactobacillus acidophilus

ACTIVE COMPARATOR

arm 1 : will receive Lactobacillus acidophilus 20 billion colony forming unit (CFU) of Lactobacillus acidophilus (1 capsule of 10 billion CFU twice daily) for six months

Drug: Lactobacillus acidophilus will be assigned for arm 1

arm 2: Vitayami caps

ACTIVE COMPARATOR

44 patients included will receive 1 tablet twice daily of vitayami caps which is a trace elements contains (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) with infliximab in a dose of 5mg/kg) for six months

Drug: trace elements

Arm 3 (control)

PLACEBO COMPARATOR

will receive infliximab only , no lactobacillous or trace elements no intervention drug

Other: Control Arm - standard of care

Interventions

Lactobacillus acidophilus will be assigned for arm 1 DRUG

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

arm 1 : 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)

arm 2: Vitayami caps

Control Arm - standard of care OTHER

control arm contain no drug only standard of care

Arm 3 (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

• 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).
• 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).
• Patients with autoimmune diseases.
• Patients with colorectal cancer.
• Patients previously received probiotics or trace elements in the previous month before recruitment.
• Liver cirrhosis.
• 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).
• Pregnancy or Lactation (40)
• Patients on conventional therapy (5-amino salicylic acid treatment).

Sponsors & Collaborators

• National Hepatology & Tropical Medicine Research Institute: lead

Study Sites (1)

NHTMRI(national hepatology and tropical medicine research institute)

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Trace Elements

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Mai Abd el moneim, Msc of clinical pharmacy

CONTACT

+201151355664; monem_mai@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist at National Hepatology and Tropical Medicine Research Institute (NHTMRI)

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: July 2, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: from 7/8/2026(start date ) end date (1/12/2027)

Locations

EG (1)