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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 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. |
|
| Control | No Intervention | The patients will be asked to continue their usual lifestyle without change in their usual medication and nutritional intake. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilac | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease course | Change in frequency of flares over 2 months | 8 weeks |
| Disease course | Change in hospitalizations rates over 2 months | 8 weeks |
| Nutrition Status | Change in macro- and micronutrient intake by administrating 24 h recall to be analysed by Nutritionist Pro Software | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Status | Change in quality-of-life score as per WHOQOL Bref | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zahra Sadek, PhD | Contact | +9613947985 | zahrasadek81@hotmail.com | |
| Nadeen Zayour | Contact | +96170039975 | nadeen.zayour@zhumc.org.lb |
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Hallal | Al Zahraa Hospital University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| zahra Sadek | Recruiting | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D000073923 | Food Intolerance |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003092 | Colitis |
| D003108 | Colonic Diseases |