Smoking in IBD PatientsNCT05196282
Influence of Smoking Cessation or Switching to THS on Disease Activity in IBD Patients.
An observational study of Smoking in IBD Patients, run by HaFCED e.K..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Smoking in IBD Patients
- What is being tested?
- Smoking cessation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2022to 15 Jan 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Smoking IBD patients under treatment
Who may be able to join
- For all patients:
- Patient has signed the ICF (Informed Consent Form) and is able to understand the information provided in the ICF. Patient can sign or not the optional ICF on long-term biobanking of samples.
- 19 years ≤ patient's age ≤ 75 years old
- Patients who were diagnosed with UC or CD.
- Patient's disease activity is mild to moderate (PMS ≤ 6; CDAI: ≤ 300) and has not changed for at least the last 3 months, as judged by the Investigator. a
- Patient is ready to comply with the study procedures (including readiness to accept smoking abstinence and/or use of THS).
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- Patient has smoked at least 5 commercially available and/or "roll your own cigarette" every day (no cigarette brand restriction) for at least the last 1 year, based on self-reporting. Smoking status will be verified based on a urinary cotinine test (i.e., cotinine ≥ 200 ng/mL). Specific to patients who prefer to continue using nicotine-containing and tobacco product after having been advised to quit smoking:
- Not intending to quit using THS or smoking cigarettes within the next 6 months (to be checked at V2). Specific to patients who prefer to stop smoking cigarettes:
- Any patient who is willing to attempt quitting cigarette smoking
Who cannot join
- For all patients:
- Patients with severe disease activity (PMS > 5; CDAI > 300), as judged by the Investigator.
- Female patients who are pregnant or breast-feeding
- Female patients who are planning to become pregnant during the next 8 months
- Patients with a history of recent and current alcohol and substance abuse
- Patient is ineligible as judged by the Investigator to participate in the study for any reason (e.g., medical, psychiatric and/or social reason), including any abnormal safety laboratory values obtained at screening that are judged as clinically significant by the investigator.
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- Patient is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners, or patients who are involuntarily incarcerated).
- Patient with any major illness/condition or evidence of an unstable clinical condition (e. g. renal, hepatic, hematologic, gastrointestinal [except the disease under study], endocrine, cardiovascular, pulmonary, immunologic, or local active infection/infectious illness) that, in the investigator's judgment, could impact study results.
- The patient has colorectal carcinoma or high-grade dysplasia adenoma.
- As per the investigator's judgment, the patient has medical conditions which require or will require in the course of the study, a medical intervention (e. g. start of treatment, surgery, hospitalization), which may interfere with the study participation and/or study results.
- Any other clinically significant medical condition, which as per the judgment of the PI would jeopardize the safety of the patient.
- Clinically significant ECG alterations that will not allow patient to participate in the study, per Investigator's discretion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, 6-arm Parallel Group, Single-center Preference Clinical Study on the Effects of Smoking Cessation or Switching From Cigarette Smoking to the Tobacco Heating System (THS) in Adult Smokers Who Have Been Diagnosed With Inflammatory Bowel Disease (IBD) and Are Under Treatment.
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.
- Conditions
- Smoking in IBD Patients
- Being tested
- Smoking cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessationOther
Patients are forced to stop smoking
| Study group | Role | What they receive |
|---|---|---|
| UC, Smoker | Not described Receives: Other: Smoking cessation | |
| UC, Smoking cessation | Not described Receives: Other: Smoking cessation | |
| UC, THS user | Not described Receives: Other: Smoking cessation | |
| CD, Smoker | Not described Receives: Other: Smoking cessation | |
| CD, Smoking cessation | Not described Receives: Other: Smoking cessation | |
| CD, THS user | Not described Receives: Other: Smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Scores
partial Mayo Score, Range from 0-9. The higher the more active
Measured: 6.5 months
Activity Scores
CDAI, Crohn's disease activity index - Range from 0-600. The higher the more active
Measured: 6.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Jan 2022 (estimated)
- Primary completion15 Jan 2023 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking in IBD PatientsStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaFCED e.K.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196282
- Sponsor's protocol ID
- HW-001-DE
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 6-arm Parallel Group, Single-center Preference Clinical Study on the Effects of Smoking Cessation or Switching From Cigarette Smoking to the Tobacco Heating System (THS) in Adult Smokers Who Have Been Diagnosed With Inflammatory Bowel Disease (IBD) and Are Under Treatment.
- ClinicalTrials.gov ID
- NCT05196282
- Acronym / sponsor ID
- HW-001-DE
- Conditions
- Smoking in IBD Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HaFCED e.K.University, hospital or other
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 19 Jan 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| UC, Smoker | – | Other: Smoking cessation |
| UC, Smoking cessation | – | Other: Smoking cessation |
| UC, THS user | – | Other: Smoking cessation |
| CD, Smoker | – | Other: Smoking cessation |
| CD, Smoking cessation | – | Other: Smoking cessation |
| CD, THS user | – | Other: Smoking cessation |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Smoking IBD patients under treatment
Key inclusion criteria (9 listed)
- Patient has signed the ICF (Informed Consent Form) and is able to understand the information provided in the ICF. Patient can sign or not the optional ICF on long-term biobanking of samples.
- 19 years ≤ patient's age ≤ 75 years old
- Patients who were diagnosed with UC or CD.
- Patient's disease activity is mild to moderate (PMS ≤ 6; CDAI: ≤ 300) and has not changed for at least the last 3 months, as judged by the Investigator. a
- Patient is ready to comply with the study procedures (including readiness to accept smoking abstinence and/or use of THS).
Key exclusion criteria (12 listed)
- Patients with severe disease activity (PMS > 5; CDAI > 300), as judged by the Investigator.
- Female patients who are pregnant or breast-feeding
- Female patients who are planning to become pregnant during the next 8 months
- Patients with a history of recent and current alcohol and substance abuse
- Patient is ineligible as judged by the Investigator to participate in the study for any reason (e.g., medical, psychiatric and/or social reason), including any abnormal safety laboratory values obtained at screening that are judged as clinically significant by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessationPatients are forced to stop smoking | Other | CD, Smoker, CD, Smoking cessation, CD, THS user, UC, Smoker, UC, Smoking cessation, UC, THS user |
Primary outcome
Activity Scores
Time frame: 6.5 months
partial Mayo Score, Range from 0-9. The higher the more active
Activity Scores
Time frame: 6.5 months
CDAI, Crohn's disease activity index - Range from 0-600. The higher the more active
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking in IBD Patients, run by HaFCED e.K..
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 9 inclusion and 12 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 19 Jan 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 Stefanie Howaldt, MD (+4940423265151, Howaldt@hafced.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Scores (time frame: 6.5 months). The study lists 2 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 19 Jan 2022.