Factors Associated with Fecal Incontinence in Women of Childbearing Age with Crohn's Disease.
Charlène Brochard, Laurent Siproudhis, Jean Levêque...
https://pubmed.ncbi.nlm.nih.gov/28394805Actively Recruiting
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID05185609
Assessment of Anorectal Function in Healthy Volunteers and Patients With Inflammatory Bowel Disease
Led by Region Örebro County · Updated on 2022-02-03
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring anorectal function in people with inflammatory bowel disease (IBD), focusing on those who have symptoms despite their disease being inactive. The study compares symptomatic IBD patients in remission with healthy volunteers and asymptomatic IBD patients to better understand bowel function issues and related psychological symptoms. It also aims to evaluate two different testing methods for rectal sensitivity and compliance. Participants include healthy volunteers aged 18 to 65, asymptomatic IBD patients in remission, and symptomatic patients with ulcerative colitis or Crohn's disease affecting the lower bowel or perianal area. The study involves tests using high-resolution anorectal manometry (HRAM) and a barostat procedure to measure rectal sensitivity and compliance, alongside questionnaires about gastrointestinal symptoms and psychological health. Biological samples such as blood, stool, and mucosal biopsies are collected for molecular analysis. During the study, participants undergo pressure measurements, sensation tests, and complete multiple validated questionnaires assessing symptoms, anxiety, depression, and personality. Researchers will analyze biological samples and correlate findings with clinical and psychological data. The study measures include rectal compliance and sensitivity, anal pressures, coordination during defecation, symptom severity, psychological factors, and molecular markers. This comprehensive approach helps understand the causes of persistent symptoms in IBD remission and the relationship between different assessment methods.
CONDITIONS
Brief Title
Assessment of Anorectal Function in Patients With Inflammatory Bowel Disease
Who Can Participate
Age: 18Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy volunteers
- Symptomatic IBD patients with moderate to severe disease in remission and ongoing symptoms
- Asymptomatic IBD patients with moderate to severe disease in remission without symptoms
- Age between 18 and 65 years
You will not qualify if you...
- For healthy volunteers: gastrointestinal disease or functional gastrointestinal symptoms
- For healthy volunteers: psychiatric disease
- For all participants: anal or pelvic surgery including interventions during delivery
- For all participants: diabetes, cardiovascular, renal, or hepatic diseases
- For all participants: recent or current treatment with drugs affecting intestinal function or mood, including antidepressants, probiotics, or systemic steroids within 2 weeks
- History of alcohol or drug abuse
- For IBD patients: active disease
- Patients taking antidiarrheal or laxatives must have a 48-hour washout period before participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo anorectal function testing using high-resolution anorectal manometry (HRAM) and a standardized barostat procedure to assess rectal sensitivity and compliance, along with validated questionnaires to evaluate gastrointestinal symptoms and psychological parameters.
1 visit (in-person)
Sample Collection
Duration - 1 day
Participants provide biological samples including blood, stool, and rectal mucosal biopsies for molecular and multi-omics analyses to explore associations with clinical and psychological phenotypes.
1 visit (in-person)
Long-term Monitoring
Duration - Up to study completion date
Participants are observed for ongoing symptoms and clinical outcomes related to anorectal function and inflammatory bowel disease in remission.
Additional assessments may occur depending on participant status
Trial Site Locations
Total: 1 location
1
University hospital Örebro
Örebro, Sweden, 70185
Actively Recruiting
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Research Team
L
Lucian Marinica Grando, phd student
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Published Research Related To This Trial
Risk of anal incontinence in women with inflammatory bowel diseases after delivery.
J Kozeluhova, J Kotyza, K Balihar...
https://pubmed.ncbi.nlm.nih.gov/28664741Fecal Incontinence Among Patients With Crohn's Disease: Does Awareness Change Anything?
David B Stewart
https://pubmed.ncbi.nlm.nih.gov/28682961Validation of Risk Factors for Fecal Incontinence in Patients With Crohn's Disease.
Paul F Vollebregt, Arjan P Visscher, Adriaan A van Bodegraven...
https://pubmed.ncbi.nlm.nih.gov/28682970Prevalence of and Factors Associated With Fecal Incontinence: Results From a Population-Based Survey.
Stacy B Menees, Christopher V Almario, Brennan M R Spiegel...
https://pubmed.ncbi.nlm.nih.gov/29408460Quality of life in inflammatory bowel disease in remission: the impact of IBS-like symptoms and associated psychological factors.
Magnus Simrén, Jenny Axelsson, Rolf Gillberg...
https://pubmed.ncbi.nlm.nih.gov/11866278IBS-like symptoms in patients with inflammatory bowel disease in remission; relationships with quality of life and coping behavior.
Itta M Minderhoud, Bas Oldenburg, Josta A Wismeijer...
https://pubmed.ncbi.nlm.nih.gov/15139501Pelvic floor dysfunction in inflammatory bowel disease.
A Bondurri, A Maffioli, P Danelli
https://pubmed.ncbi.nlm.nih.gov/26603727Prevalence of irritable bowel syndrome-like symptoms in ulcerative colitis patients with clinical and endoscopic evidence of remission: prospective multicenter study.
Nobuhiko Fukuba, Shunji Ishihara, Yasumasa Tada...
https://pubmed.ncbi.nlm.nih.gov/24646420Ulcerative colitis and irritable bowel syndrome: relationships with quality of life.
Reza Ansari, Fatemeh Attari, Hadi Razjouyan...
https://pubmed.ncbi.nlm.nih.gov/18090990