An interventional study of Trilac in Inflammatory Bowel Diseases, Quality of Life and Food Intolerance, sponsored by Lebanese University. Recruiting at 1 site in Lebanon. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Lebanese University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Dietary Supplement: Trilac
The patients will be asked to continue their usual lifestyle without change in their usual medication and nutritional intake.
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.
Disease course
Change in frequency of flares over 2 months
Time frame: 8 weeks
Disease course
Change in hospitalizations rates over 2 months
Time frame: 8 weeks
Nutrition Status
Change in macro- and micronutrient intake by administrating 24 h recall to be analysed by Nutritionist Pro Software
Time frame: 8 weeks
Quality of Life Status
Change in quality-of-life score as per WHOQOL Bref
Time frame: 8 weeks
Plan to share: No
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Lebanese University