NCT06392061

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Lebanese University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Bowel Diseases
• Quality of Life
• Food Intolerance
• Flare Up
• Ulcerative Colitis
• Crohn Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-05-30
• Completion: 2024-06-30
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

1 site across 1 country: Lebanon