Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease

Quality of Life Clinical Trial

Official title:

Assessment of Medical and Nutritional Status Post-Probiotic Intake in Patients Diagnosed With Inflammatory Bowel Disease: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392061
• Other study ID #: LebaneseUni
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Lebanese University
• Contact: zahra Sadek, PhD
• Phone: +9613947985
• Email: zahrasadek81[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Lebanon	zahra Sadek	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Lebanese University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease course	Change in frequency of flares over 2 months	8 weeks
Primary	Disease course	Change in hospitalizations rates over 2 months	8 weeks
Primary	Nutrition Status	Change in macro- and micronutrient intake by administrating 24 h recall to be analysed by Nutritionist Pro Software	8 weeks
Secondary	Quality of Life Status	Change in quality-of-life score as per WHOQOL Bref	8 weeks