The Prevalence of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Patients Suspected of Hemorrhagic Proctosigmoiditis

NCT07061899 | Active Not Recruiting

• 1 other identifier: SOS Proctitis
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 5

Brief Summary

Background Chlamydia trachomatis and Neisseria gonorrhoeae can cause infectious proctitis, which macroscopically cannot be distinguished from haemorrhagic proctosigmoiditis (HP) caused by inflammatory bowel disease. In Denmark, general practitioners are advised to consider whether patients presenting with proctitis symptoms might have a sexually transmitted infection (STI). However, there is no requirement for STI testing before referring the patient to a specialised department. At specialised departments, it is not standard practice to systematically inquire about sexual risk behaviour or to test for Chlamydia and Gonorrhoea. As a result, there is no data on how many patients diagnosed with HP due to chronic inflammatory bowel disease are also positive for an STI, either as the sole cause or as a contributing factor to their inflammation. Chlamydia and Gonorrhoea are the most common causes of symptomatic, sexually transmitted proctitis and are increasingly prevalent in Denmark. Materials and methods Since diagnosing haemorrhagic proctosigmoiditis requires an endoscopy (sigmoidoscopy or colonoscopy), all newly diagnosed patients will undergo such an examination. Moreover, an endoscopy is often performed in individuals with refractory proctosigmoiditis. If inflammation is observed up to 35 cm from the anal opening, an additional swab will be taken during the procedure to test for Chlamydia and Gonorrhoea using standard PCR techniques. If the swab is not taken during the endoscopy, it will be collected during a follow-up outpatient visit. The tests will be analysed immediately at the Department of Microbiology, Aarhus University Hospital. Over 24 months, the investigators will examine all patients diagnosed with proctosigmoiditis at the Department of Liver, Digestive, and Gastrointestinal Diseases at Aarhus University Hospital (AUH), Viborg/Silkeborg Regional Hospital, Horsens Regional Hospital, Gødstrup Regional Hospital and Randers Regional Hospital. This includes patients with inflammation extending from the anal opening to 35 cm proximally, as well as those with treatment-refractory proctosigmoiditis. All patient data will be prospectively collected through Region Midt EPJ, Denmark's electronic medical record system, and registered in a REDCap database. The tested patients will undergo standard follow-up at their respective departments. Supple-mentary, patients who test positive for Chlamydia or Gonorrhoea will be offered treatment at the Venereology Outpatient Clinic, Aarhus University Hospital. If they are only on 5-ASA treatment and it is found reasonable to pause their treatment, their IBD treatment will be paused during treatment for STI. The studied patients will form a prospective cohort, and their disease progression, including the extent of haemorrhagic proctitis and current medication, will be recorded. Endpoints Primary endpoint: \- Prevalence of Chlamydia and Gonorrhoea in our cohort of individuals with suspected haemorrhagic proctitis. Secondary endpoints:

• Prevalence of Chlamydia and Gonorrhoea across gender
• Prevalence of Chlamydia and Gonorrhoea across age groups
• Prevalence of Chlamydia and Gonorrhoea depending on time for diagnosis
• Frequency of clinical remission of proctitis after treatment with STI-related antibiotics
• Differences in the frequency of clinical remission between those with a negative or positive STI test at inclusion

Conditions

Proctitis, Ulcerative; Sexually Transmitted Disease (STD); Ulcerative Proctosigmoiditis

Keywords

Proctitis, Ulcerative; Ulcerative Proctosigmoiditis; Chlamydia trachomatis; Neisseria gonorrhoeae; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (2)

• Prevalence of Chlamydia in individuals with suspected haemorrhagic proctitis

  Number of Chlamydia positive individuals on rectal swap

  2 years

• Prevalence of Gonorrhoea in individuals with suspected haemorrhagic proctitis

  Number of Gonorrhoea positive individuals on rectal swap

  2 years

Secondary Outcomes (8)

• Prevalence of Chlamydia across gender

  2 years

• Prevalence Gonorrhoea across gender

  2 years

• Prevalence of Chlamydia across age groups

  2 years

• Prevalence of Gonorrhoea across age groups

  2 years

• Prevalence of Chlamydia depending on time for diagnosis

  2 years

Study Arms (2)

Newly diagnosed haemorrhagic proctitis

First-ever episode, endoscopically confirmed within the specified enrolment window.

Diagnostic Test: Anal swap for Chlamydia and Gonorrhoea

Recurrent haemorrhagic proctitis

One or more prior confirmed episodes and current relapse confirmed endoscopically.

Diagnostic Test: Anal swap for Chlamydia and Gonorrhoea

Interventions

Anal swap for Chlamydia and Gonorrhoea DIAGNOSTIC_TEST

If inflammation is observed on endoscopy up to 35 cm from the anal opening, a swab will be taken during the procedure to test for Chlamydia and Gonorrhoea using standard PCR techniques. If the swab is not taken during the endoscopy, it will be collected during a follow-up outpatient visit. The tests will be analysed immediately at the Department of Microbiology, Aarhus University Hospital. If positve, the patient will be offered treatment at the department of Venerological diseases.

Newly diagnosed haemorrhagic proctitis; Recurrent haemorrhagic proctitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suspected of haemorrhagic proctosigmoiditis with either newly diagnosed or recurrent disease who undergo lower endoscopy

You may qualify if:

• Patients suspected of haemorrhagic proctosigmoiditis with either newly diagnosed or recurrent disease who undergo lower endoscopy

You may not qualify if:

• Patients who does not accept the swap to be taken

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Regional Hospital Randers: collaborator
• Central Jutland Regional Hospital: collaborator
• Gødstrup Hospital: collaborator

Study Sites (5)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Gødstrup Regional Hospital

Herning, 7700, Denmark

Location

Randers Regional Hospital

Randers, 8930, Denmark

Location

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

Viborg Regional Hospital

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Proctitis; Ulcer; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes

Study Officials

• Christan L Hvass, Professor

  Aarhus University Hospital

  STUDY CHAIR

• Line Kibsgaard, MD, Ph.D.

  Aarhus University Hospital

  STUDY CHAIR

• Anders K Dige, Consultant, Ph.D.

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: July 11, 2025
• Study Start: October 1, 2024
• Primary Completion: December 15, 2025
• Study Completion: March 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be shared beginning 9 months and ending 36 months foliowing article publication.
• Access Criteria: Data will be shared to researchers who provide a methodologically sound proposal and have been approved by the principal investigator.

Locations

DK (5)