Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease

Lebanese University

Status: Enrolling

Conditions: Food Intolerance; Quality of Life; Ulcerative Colitis; Inflammatory Bowel Diseases; Flare Up; Crohn Disease

Treatments: Dietary Supplement: Trilac

Study type: Interventional

Funder types: Other

Identifiers

NCT06392061

LebaneseUni

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Probiotic

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Trilac

Control

No Intervention group

Description:

The patients will be asked to continue their usual lifestyle without change in their usual medication and nutritional intake.