Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease

NCT06392061 | Recruiting

• 1 other identifier: LebaneseUni
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Quality of Life Status

  8 weeks

Study Arms (2)

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.

Dietary Supplement: Trilac

Control

NO INTERVENTION

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

Interventions

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.

Probiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnant or lactating women
• patients who use probiotics within the study period.

Sponsors & Collaborators

• Lebanese University: lead

Study Sites (1)

zahra Sadek

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Food Intolerance; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colitis; Colonic Diseases

Study Officials

• Mahmoud Hallal

  Al Zahraa Hospital University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zahra Sadek, PhD

CONTACT

+9613947985; zahrasadek81@hotmail.com

Nadeen Zayour

CONTACT

+96170039975; nadeen.zayour@zhumc.org.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 30, 2024
• Study Start: April 1, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)