Ulcerative ColitisNCT06583863
Parasitic Infections and Ulcerative Colitis: Combining Anti-parasitic and Immunomodulatory Treatments May Achieve Remission
A study testing Echinacea Extract and MetroNIDAZOLE 500 MG Oral Tablet [Flagyl] in people with Ulcerative Colitis, run by Benha University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Echinacea Extract and MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2023to 12 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ulcerative Colitis patients had active disease,
- Patients had parasitic infection by G. lambellia,
- Patients free of parasitic infection,
- Patients free of exclusion criteria..
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Echinacea Extract, MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echinacea ExtractDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Drug: Echinacea Extract |
| Group I | Active comparator | Not described Receives: Drug: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl] |
| Group II | Active comparator | Not described Receives: Drug: Echinacea Extract; Drug: MetroNIDAZOLE 500 MG Oral Tablet [Flagyl] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start12 Sep 2023
- Primary completion1 Apr 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba M. Aboelela, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583863
- Sponsor's protocol ID
- RC 16-7-2024
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasitic Infection Flares up the Activity of Ulcerative Colitis; However, Combined Immunomodulatory Therapy With Anti-parasitic Treatment Could Proceed Toward Remission
- ClinicalTrials.gov ID
- NCT06583863
- Acronym / sponsor ID
- RC 16-7-2024
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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] |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ulcerative Colitis patients had active disease,
- Patients had parasitic infection by G. lambellia,
- Patients free of parasitic infection,
- Patients free of exclusion criteria..
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echinacea Extract175 mg of Echinacea extract was provided as an immunlant therapy twice daily. | Drug | Control Group, Group II |
| MetroNIDAZOLE 500 MG Oral Tablet [Flagyl]500 mg of metronidazole was provided as an oral tablets twice daily | Drug | Group I, Group II |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echinacea Extract and MetroNIDAZOLE 500 MG Oral Tablet [Flagyl] in people with Ulcerative Colitis, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.