Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Food Intolerance; Flare Up
• Intervention / Treatment: Dietary supplement: Trilac

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: zahra Sadek, PhD; Phone Number: +9613947985; Email: zahrasadek81@hotmail.com
• Study Contact Backup: Name: Nadeen Zayour; Phone Number: +96170039975; Email: nadeen.zayour@zhumc.org.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • zahra Sadek
    • Contact: zahra Sadek, PhD; Phone Number: +9613947985; Email: zahrasadek81@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control; The patients will be asked to continue their usual lifestyle without change in their usual medication and nutritional intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Status	Change in quality-of-life score as per WHOQOL Bref	8 weeks

Collaborators and Investigators

• Sponsor: Lebanese University
• Investigators: Principal Investigator: Mahmoud Hallal, Al Zahraa Hospital University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Food Intolerance
• Other Study ID Numbers: LebaneseUni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No