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

September 3, 2024 updated by: Heba M. Aboelela, Benha University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Qalyoubia
      • Banhā, El Qalyoubia, Egypt, 13511
        • Benha Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Drug: Echinacea Extract
175 mg of Echinacea extract was provided as an immunlant therapy twice daily.
Active Comparator: Group II
Drug: Echinacea Extract
175 mg of Echinacea extract was provided as an immunlant therapy twice daily.
Drug: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]
500 mg of metronidazole was provided as an oral tablets twice daily
Active Comparator: Group I
Drug: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]
500 mg of metronidazole was provided as an oral tablets twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

June 12, 2024

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

September 4, 2024

Last Update Submitted That Met QC Criteria

September 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 16-7-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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