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

NCT ID: NCT06583863

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2024-06-12

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Group

Group Type ACTIVE_COMPARATOR

Echinacea Extract

Intervention Type DRUG

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

Group I

Group Type ACTIVE_COMPARATOR

MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]

Intervention Type DRUG

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

Group II

Group Type ACTIVE_COMPARATOR

Echinacea Extract

Intervention Type DRUG

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

MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]

Intervention Type DRUG

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

Interventions

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Echinacea Extract

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

Intervention Type DRUG

MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Heba M. Aboelela

Lecturer of Medical Parasitology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha faculty of Medicine

Banhā, El Qalyoubia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC 16-7-2024

Identifier Type: -

Identifier Source: org_study_id

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