Anal FissureNCT05405634
Microbiota in Chronic Anal Fissure and Its Association With Prognosis
An observational study of Anal Fissure and Microbial Colonization, run by Lasse Krogsbøll.
Trial summary
In this study, we will try to answer the following questions: 1. What are the salient features of the microbiota in chronic anal fissure? 2. Are these features associated with prognosis and response to therapy? 3. Does an anal fissure swab and anal fissure tissue give comparable bacteriological results? Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anal Fissure, Microbial Colonization
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Jun 2023
- Phase
- Observational
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: As above.
Who may be able to join
- Three samples will be included:
- Consecutive patients referred to the outpatient clinic at the Digestive Disease Centre, Bispebjerg Hospital in Denmark for botox injection for chronic anal fissure. Thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy
- Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia
- Healthy volunteers. These will be recruited among staff at the Digestive Disease Centre, Bispebjerg Hospital, Denmark.
- Samples 1 and 2 will not be independent, as patients from group 1 may be included in group 2 depending on the clinical course. No direct comparisons between these two groups are planned (see analysis section).
Who cannot join
- Symptom duration of less than 8 weeks (groups 1 and 2)
- Known or suspected Crohn's disease
- Known or suspected active venereal disease.
Trial locations and contacts
No sites are listed yet.
Andreas Nordholm-Carstensen, MD, PhD contact
About this study
Official title: Microbiota in Chronic Anal Fissure and Its Association With Prognosis - Prospective Cohort Study
In this study, we will try to answer the following questions:
- What are the salient features of the microbiota in chronic anal fissure?
- Are these features associated with prognosis and response to therapy?
- Does an anal fissure swab and anal fissure tissue give comparable bacteriological results?
Read the detailed description
To allow rational planning of therapeutic trials of antimicrobial or biofilm degrading medical therapy, a better understanding of the microbiota of chronic anal fissures is needed. Previous studies have relied on culture, whereas we will employ molecular methods.
We will collect bacteriological samples from patients referred to us with anal fissure, in order to characterize the microbiota. To see if the microbiota is distinct from or similar to the rectal microbiota, we will also collect a swap from the rectum. We will also collect swaps from the anal verge of healthy volunteers without anal fissure, to see if the microbiota in anal fissures are distinct from the normal anodermal microbiota. To examine whether a swap is a reliable method for characterizing the microbiota in anal fissure, we will also collect excised anal fissure tissue from the subset of patients with a clinical indication for fissurectomy in general anaesthesia, and compare the analysis results with those from the swap.
We will re-assess the patients clinically and with a repeat swap after 3 months, and perform an exploratory analysis in order to identify possible features of the microbiota that are associated with poor response to therapy.
- Conditions
- Anal Fissure, Microbial Colonization
- Medical subject headings
- Fissure in Ano, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic analfissure | 1. Consecutive patients referred to the outpatient clinic at the Digestive Disease Centre, Bispebjerg Hospital in Denmark for botox injection for chronic anal fissure. Thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy | |
| Patients with an indication for fissurectomy | Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia | |
| Healthy volunteers | Healthy volunteers. These will be recruited among staff at the Digestive Disease Centre, Bispebjerg Hospital, Denmark. |
What is being measured
The primary outcome is the main question the study is designed to answer.
16S/18S RNA
Measured: Baseline
16S/18S RNA
Measured: 3 months
PICRUSt2
Measured: Baseline
PICRUSt2
Measured: 3 months
Healing of anal fissure after 3 months
Defined by complete patient-reported resolution of pain combined with healed fissure on clinical examination
Measured: 3 months
Change from baseline in pain severity both during and after defecation
Numerical rating scale 1-10.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study startSep 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FissureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lasse Krogsbøll
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lasse Krogsbøll, Bispebjerg Hospital
- Investigators
- Lasse T Krogsbøll, MD, PhD, Principal investigator, Digestive disease center, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405634
- Sponsor's protocol ID
- Microbiota in anal fissure
- Status last verified
- Jun 2022
- First submitted
- 20 May 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota in Chronic Anal Fissure and Its Association With Prognosis - Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05405634
- Acronym / sponsor ID
- Microbiota in anal fissure
- Conditions
- Anal Fissure, Microbial Colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lasse KrogsbøllUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 6 Jun 2022 (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.
In this study, we will try to answer the following questions:
- What are the salient features of the microbiota in chronic anal fissure?
- Are these features associated with prognosis and response to therapy?
- Does an anal fissure swab and anal fissure tissue give comparable bacteriological results?
Detailed description
To allow rational planning of therapeutic trials of antimicrobial or biofilm degrading medical therapy, a better understanding of the microbiota of chronic anal fissures is needed. Previous studies have relied on culture, whereas we will employ molecular methods.
We will collect bacteriological samples from patients referred to us with anal fissure, in order to characterize the microbiota. To see if the microbiota is distinct from or similar to the rectal microbiota, we will also collect a swap from the rectum. We will also collect swaps from the anal verge of healthy volunteers without anal fissure, to see if the microbiota in anal fissures are distinct from the normal anodermal microbiota. To examine whether a swap is a reliable method for characterizing the microbiota in anal fissure, we will also collect excised anal fissure tissue from the subset of patients with a clinical indication for fissurectomy in general anaesthesia, and compare the analysis results with those from the swap.
We will re-assess the patients clinically and with a repeat swap after 3 months, and perform an exploratory analysis in order to identify possible features of the microbiota that are associated with poor response to therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic analfissure | – | –1. Consecutive patients referred to the outpatient clinic at the Digestive Disease Centre, Bispebjerg Hospital in Denmark for botox injection for chronic anal fissure. Thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy |
| Patients with an indication for fissurectomy | – | –Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia |
| Healthy volunteers | – | –Healthy volunteers. These will be recruited among staff at the Digestive Disease Centre, Bispebjerg Hospital, Denmark. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- As above.
Key inclusion criteria (5 listed)
- Consecutive patients referred to the outpatient clinic at the Digestive Disease Centre, Bispebjerg Hospital in Denmark for botox injection for chronic anal fissure. Thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy
- Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia
- Healthy volunteers. These will be recruited among staff at the Digestive Disease Centre, Bispebjerg Hospital, Denmark.
- Samples 1 and 2 will not be independent, as patients from group 1 may be included in group 2 depending on the clinical course. No direct comparisons between these two groups are planned (see analysis section).
Key exclusion criteria (3 listed)
- Symptom duration of less than 8 weeks (groups 1 and 2)
- Known or suspected Crohn's disease
- Known or suspected active venereal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
16S/18S RNA
Time frame: Baseline
16S/18S RNA
Time frame: 3 months
PICRUSt2
Time frame: Baseline
PICRUSt2
Time frame: 3 months
Healing of anal fissure after 3 months
Time frame: 3 months
Defined by complete patient-reported resolution of pain combined with healed fissure on clinical examination
Change from baseline in pain severity both during and after defecation
Time frame: 3 months
Numerical rating scale 1-10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Andreas Nordholm-Carstensen, MD, PhD contact
Lasse T Krogsbøll, MD, PhD principal investigator
Digestive disease center, Bispebjerg Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fissure and Microbial Colonization, run by Lasse Krogsbøll.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lasse T Krogsbøll, MD, PhD (0045 51684692 ext. 0045 28700717, lasse.theis.krogsboell@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16S/18S RNA (time frame: Baseline). The study lists 6 primary outcomes in all. 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 6 Jun 2022.