Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Flare Up; Crohn Disease; Inflammatory Bowel Diseases; Quality of Life; Ulcerative Colitis; Food Intolerance
• Interventions: Dietary Supplement: Trilac

• Registration Number: NCT06392061
• Lead Sponsor: Lebanese University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-01
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-26
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Trilac	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.

Primary Outcome Measures

Name	Time	Method
Disease course	8 weeks	Change in hospitalizations rates 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 Outcome Measures

Name	Time	Method
Quality of Life Status	8 weeks	Change in quality-of-life score as per WHOQOL Bref

Trial Locations

Locations (1)

zahra Sadek; 🇱🇧 Beirut, Lebanon