Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease
NCT ID: NCT06392061
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-01
2024-06-30
Brief Summary
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Patients with UC and CD will be recruited from the endoscopy unit's outpatients and divided into two groups: a control group and an intervention probiotic group. The intervention probiotic group will receive the probiotic intervention for 2 months. During the study period, two visits will be scheduled for all patients.
At each visit, medical and nutrition surveys will be filled out, and body composition measurements will be conducted. These assessments will help evaluate the impact of probiotic administration on the participants' disease progression, their quality of life, and their nutritional status.
Overall, the study aims to provide insights into the potential benefits of probiotic supplementation in managing IBD and improving the well-being of patients with these conditions.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Probiotic
Contains 4 strains of naturally-occurring bacteria including: Lactobacillus acidophilus, LA-5®, Bifidobacterium animalis, BB-12®, Streptococcus thermophiles, STY-31 and Lactobacillus delbrueckii subsp. Bulgaricus LBY-27 in concentration of 4.5 milliards CFU/capsule.
Trilac
Trilac® is a dietary supplement developed by Surveal Pharma to support digestive health and overall well-being. This probiotic contains 4 strains of naturally-occurring bacteria including: Lactobacillus acidophilus, LA-5®, Bifidobacterium animalis, BB-12®, Streptococcus thermophiles, STY-31 and Lactobacillus delbrueckii subsp. Bulgaricus LBY-27 in concentration of 4.5 milliards CFU/capsule. Patients in the probiotic group will be instructed to take one tablet per day for a period of 8 weeks.
Control
The patients will be asked to continue their usual lifestyle without change in their usual medication and nutritional intake.
No interventions assigned to this group
Interventions
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Trilac
Trilac® is a dietary supplement developed by Surveal Pharma to support digestive health and overall well-being. This probiotic contains 4 strains of naturally-occurring bacteria including: Lactobacillus acidophilus, LA-5®, Bifidobacterium animalis, BB-12®, Streptococcus thermophiles, STY-31 and Lactobacillus delbrueckii subsp. Bulgaricus LBY-27 in concentration of 4.5 milliards CFU/capsule. Patients in the probiotic group will be instructed to take one tablet per day for a period of 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* have stable inactive disease.
* have not used any probiotics within the two months before the investigation.
Exclusion Criteria
* patients who use probiotics within the study period.
18 Years
65 Years
ALL
Yes
Sponsors
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Lebanese University
OTHER
Responsible Party
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Zahra SADEK
Associate Professor
Principal Investigators
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Mahmoud Hallal
Role: PRINCIPAL_INVESTIGATOR
Al Zahraa Hospital University Medical Center
Locations
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zahra Sadek
Beirut, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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zahra Sadek, PhD
Role: primary
Other Identifiers
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LebaneseUni
Identifier Type: -
Identifier Source: org_study_id