Crohn DiseasePhase 4NCT04682522
Flagyl Microbiome in Crohn's Disease
A Phase 4 study testing Metronidazole Oral in people with Crohn Disease, run by University of Louisville at 1 site in United States.
Trial summary
This study will compare the types of bacteria in the colon before and after colon resection surgery. The investigator will also compare standard post-operative antibiotic treatment to flagyl (metronidazole) treatment post-operatively to see if giving the antibiotic, decreases the incidence of return of Crohn's disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Metronidazole Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 15 Aug 2023
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-80 years old who is deemed an acceptable surgical candidate for ileocolic resection.
Who cannot join
- any patients that are dependent on total parenteral nutrition and unable to tolerate oral intake
- patients who will undergo resection but will have an ileostomy created
- patients on maintenance antibiotics for their disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University Surgical Associates
Louisville, Kentucky, 40202
About this study
Official title: Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease
This study will compare the types of bacteria in the colon before and after colon resection surgery. The investigator will also compare standard post-operative antibiotic treatment to flagyl (metronidazole) treatment post-operatively to see if giving the antibiotic, decreases the incidence of return of Crohn's disease.
Read the detailed description
Participants who are scheduled for colon resection for Crohn's disease will be invited to take part in this randomized study. Participants will be randomized 1:1 to either Metronidazole 250 mg three times a day, starting after surgery, for three months, or the local usual standard of care after surgery, which may be a different antibiotic prescribed by the physician.
Participants will also provide a stool sample at the following time points: prior to surgery, the day of discharge, at their follow-up appointment (usually about two weeks after surgery), three months, and six months.
Participants will also be followed to determine their clinical outcome.
- Conditions
- Crohn Disease
- Being tested
- Metronidazole Oral
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole OralDrug
Also called Flagyl
250 mg Three times a day
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Active comparator | Metronidazole 250 mg three times a day Receives: Drug: Metronidazole Oral |
| Standard care | No intervention | Standard post-operative care, which may or may not include post-operative antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bacteria in the gut
Any change in the types of bacteria in the gut during the study period. This will be done by doing genetic analysis of differences in stool over time.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start21 Mar 2021
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 study groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sandykava, University of Louisville
- Investigators
- Sandra Kavalukas, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682522
- Sponsor's protocol ID
- 20.1054
- Status last verified
- Oct 2023
- First submitted
- 9 Dec 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease
- ClinicalTrials.gov ID
- NCT04682522
- Acronym / sponsor ID
- 20.1054
- Conditions
- Crohn Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 23 Dec 2020 (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.
This study will compare the types of bacteria in the colon before and after colon resection surgery. The investigator will also compare standard post-operative antibiotic treatment to flagyl (metronidazole) treatment post-operatively to see if giving the antibiotic, decreases the incidence of return of Crohn's disease.
Detailed description
Participants who are scheduled for colon resection for Crohn's disease will be invited to take part in this randomized study. Participants will be randomized 1:1 to either Metronidazole 250 mg three times a day, starting after surgery, for three months, or the local usual standard of care after surgery, which may be a different antibiotic prescribed by the physician.
Participants will also provide a stool sample at the following time points: prior to surgery, the day of discharge, at their follow-up appointment (usually about two weeks after surgery), three months, and six months.
Participants will also be followed to determine their clinical outcome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 study groups
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Active comparator | Drug: Metronidazole OralMetronidazole 250 mg three times a day |
| Standard care | No intervention | –Standard post-operative care, which may or may not include post-operative antibiotics |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20-80 years old who is deemed an acceptable surgical candidate for ileocolic resection.
Key exclusion criteria (3 listed)
- any patients that are dependent on total parenteral nutrition and unable to tolerate oral intake
- patients who will undergo resection but will have an ileostomy created
- patients on maintenance antibiotics for their disease
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 |
|---|---|---|
| Metronidazole OralAlso: Flagyl250 mg Three times a day | Drug | Metronidazole |
Primary outcome
Change in bacteria in the gut
Time frame: six months
Any change in the types of bacteria in the gut during the study period. This will be done by doing genetic analysis of differences in stool over time.
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 23 Oct 2023.
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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.
Sandra Kavalukas, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole Oral in people with Crohn Disease, run by University of Louisville at 1 site in United States.
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 1 inclusion and 3 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 23 Oct 2023. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in bacteria in the gut (time frame: six months). 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 23 Oct 2023.