Crohn Disease, Flare Up, Food Intolerance, Inflammatory Bowel Diseases, Quality of Life, Ulcerative Colitis
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTTrilac
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.
Sponsors
Lebanese University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* pregnant or lactating women * patients who use probiotics within the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease course | 8 weeks | Change in frequency of flares over 2 months |
| Nutrition Status | 8 weeks | Change in macro- and micronutrient intake by administrating 24 h recall to be analysed by Nutritionist Pro Software |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Status | 8 weeks | Change in quality-of-life score as per WHOQOL Bref |
Countries
Lebanon
Contacts
Primary Contactzahra Sadek, PhD
Backup ContactNadeen Zayour
Outcome results
None listed