Microbiota and Probiotic Therapy in Ulcerative Colitis Patients

Tanta University

Status: Completed

Conditions: Ulcerative Colitis; Probiotic Therapy; Microbiota

Treatments: Drug: Probiotics (Bacillus Clausii); Drug: Mesalamine and probiotics (Bacillus Clausii); Drug: Mesalamine

Study type: Observational

Funder types: Other

Identifiers

NCT07180186

35074/11/21

Details and patient eligibility

About

This study aimed to evaluate the role of microbiota and probiotics in Egyptian patients with ulcerative colitis.

Full description

Inflammatory bowel disease (IBD) is a group of chronic diseases that significantly affects patients' quality of life and is mainly represented by Crohn's disease (CD) and ulcerative colitis (UC).

The microbiome is a key contributor to various fundamental aspects of human health, including host metabolism, infection, and the immune response.

Changes in microbiome composition have been linked to complex multifactorial diseases, e.g., type 2 diabetes, metabolic syndrome, and non-alcoholic fatty liver syndrome, as well as inflammatory bowel disease (IBD).

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients more than 18 years.
• Patients with ulcerative colitis in remission as assessed by the clinical activity index (CAI) ≤ 4, endoscopic index (EI) ≤ 4, and no signs of acute inflammation on histological examination.

Exclusion criteria

• Active ulcerative colitis.
• Cardiac, hepatic, or renal disease.
• Pregnancy.
• History of major colonic surgery.
• Patients with any malignancy.
• Previously taking other probiotics.
• Use of steroids within the last 4 weeks before study entry.
• Use of antibiotics within the last 2 weeks before study entry

Trial design

70 participants in 4 patient groups

Group I

Description:

Patients with ulcerative colitis in remission treated with oral mesalamine.

Treatment:

Drug: Mesalamine

Group II

Description:

Patients with ulcerative colitis in remission treated with probiotics (Bacillus Clausii).

Treatment:

Drug: Probiotics (Bacillus Clausii)

Group III

Description:

Patients with ulcerative colitis in remission treated with oral mesalamine and probiotics (Bacillus Clausii).

Treatment:

Drug: Mesalamine and probiotics (Bacillus Clausii)

Group IV

Description:

Apparent healthy controls