Parasitic Infections and Ulcerative Colitis: Combining Anti-parasitic and Immunomodulatory Treatments May Achieve Remission

Not Applicable

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]; Drug: Echinacea Extract

• Registration Number: NCT06583863
• Lead Sponsor: Benha University

Brief Summary

The study aimed to explore the link between parasitic infections and the severity of ulcerative colitis (UC). 120 UC patients were divided into three groups: those without infection, those with Giardia lamblia infection treated with metronidazole, and those with Giardia infection treated with a combination of metronidazole and E. purpurea. The results revealed that patients with Giardia infections exhibited more severe UC symptoms. All groups experienced improved symptoms following treatment, but the combination therapy group demonstrated the most significant improvement. Remission rates were highest in the group without infection and the group receiving combination therapy. Additionally, the study identified E. purpurea therapy and a substantial reduction in SCCAI score as significant predictors of higher remission rates.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-12
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-12
• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-03
• Last Update Submitted: 2024-09-03
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Ulcerative Colitis patients had active disease,
• Patients had parasitic infection by G. lambellia,
• Patients free of parasitic infection,
• Patients free of exclusion criteria..

Exclusion Criteria

• Patients had Inflammatory Bowel Disease other than Ulcerative Colitis,
• Patients had multiple parasitic infections,
• Patients had infection by parasites other than G. lambellia,
• Patients who were maintained on immunosuppressant therapy,
• Patients who were in remission and patients refused to sign the written consent to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]	-
Group II	MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]	-
Control Group	Echinacea Extract	-
Group II	Echinacea Extract	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients reporting at least a 50% increase in the remission rate of parasitic infection (measured by changes in Serum CRP, Fecal calprotectin, and on the Simple Clinical Colitis Activity Index[SCCAI]) in patients with Ulcerative colitis.	4 weeks	Patients had parasitic infection showed significantly higher pre-treatment SCCAI score and FCP level than patients free of infection. Post-treatment SCCAI scores of all patients were significantly lower than the pre-treatment scores.

Trial Locations

Locations (1)

Benha faculty of Medicine; 🇪🇬 Banhā, El Qalyoubia, Egypt