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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha faculty of Medicine

Banhā, El Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echinacea Extract

Drug

175 mg of Echinacea extract was provided as an immunlant therapy twice daily.

MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]

Drug

500 mg of metronidazole was provided as an oral tablets twice daily

Primary outcomes

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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Parasitic Infection Flares up the Activity of Ulcerative Colitis; However, Combined Immunomodulatory Therapy With Anti-parasitic Treatment Could Proceed Toward Remission

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Sep 4, 2024
Registry last updated: Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed