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

NCT06583863 | Completed

• 1 other identifier: RC 16-7-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Drug: Echinacea Extract

Group I

ACTIVE COMPARATOR

Drug: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]

Group II

ACTIVE COMPARATOR

Drug: Echinacea Extract; Drug: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]

Interventions

Echinacea Extract DRUG

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

Control Group; Group II

MetroNIDAZOLE 500 MG Oral Tablet [Flagyl] DRUG

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

Group I; Group II

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha faculty of Medicine

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Echinacea extract; Metronidazole; Tablets

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Medical Parasitology

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: September 12, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 12, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Locations

EG (1)