Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease
Assessment of Medical and Nutritional Status Post-Probiotic Intake in Patients Diagnosed With Inflammatory Bowel Disease: A Randomized Clinical Trial
Lebanese University
50 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
Summary
The study is a single-center, randomized, single-blinded, controlled trial conducted at ZHUMC's endoscopy unit. It aims to assess the short-term effects of probiotic administration on disease course, quality of life, and nutritional status among patients diagnosed with inflammatory bowel disease (IBD), specifically ulcerative colitis (UC) and Crohn's disease (CD). 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.
Eligibility
Inclusion Criteria3
- Lebanese outpatients with histological diagnosis of Crohn's disease or Ulcerative Colitis from at least 6 months prior to the trial.
- have stable inactive disease.
- have not used any probiotics within the two months before the investigation.
Exclusion Criteria2
- pregnant or lactating women
- patients who use probiotics within the study period.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06392061