Influence of Smoking Cessation or Switching to THS on Disease Activity in IBD Patients.
- Conditions
- Smoking in IBD Patients
- Interventions
- Other: Smoking cessation
- Registration Number
- NCT05196282
- Lead Sponsor
- HaFCED e.K.
- Brief Summary
The main goal of this study is to evaluate the effects of smoking cessation or switching from cigarette smoking to THS (tobacco heat system) on the clinical course of UC (ulcerative colitis) and CD (Crohn´s disease) in adult smokers who were diagnosed with IBD and are under treatment.
Measures using validated/standardized assessment methods and self-reported outcomes will be assessed in patients who stop smoking or switch from smoking to using THS over the investigational period of 6 months, relative to smokers who continue smoking cigarettes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CD, Smoking cessation Smoking cessation - UC, Smoking cessation Smoking cessation - UC, Smoker Smoking cessation - UC, THS user Smoking cessation - CD, Smoker Smoking cessation - CD, THS user Smoking cessation -
- Primary Outcome Measures
Name Time Method Activity Scores 6.5 months CDAI, Crohn's disease activity index - Range from 0-600. The higher the more active
- Secondary Outcome Measures
Name Time Method