Microbiota in Chronic Anal Fissure and Its Association With Prognosis (NCT05405634) | Clinical Trial Compass
UnknownNot Applicable
Microbiota in Chronic Anal Fissure and Its Association With Prognosis
80 participantsStarted 2022-09
Plain-language 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?
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
16S/18S RNA
Timeframe: Baseline
2
16S/18S RNA
Timeframe: 3 months
3
PICRUSt2
Timeframe: Baseline
4
PICRUSt2
Timeframe: 3 months
5
Healing of anal fissure after 3 months
Timeframe: 3 months
6
Change from baseline in pain severity both during and after defecation