Crohns DiseaseInteGastNCT02476643
Integrative Gastroenterology - an Observational Trial
An observational study of Crohns Disease and Ulcerative Colitis, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohns Disease, Ulcerative Colitis, Irritable Bowel Syndrome
- What is being tested?
- Integrative Therapy
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients with Inflammentory Bowel Disease admitted to the Department of Internal and Integrative Medicine. 100 patients with Irritable Bowel Syndrome admitted to the Department of Internal and Integrative Medicine.
Who may be able to join
- 18 years or older
- diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
- written informed consent
Who cannot join
- participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, 45276
About this study
Official title: Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine
This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.
Read the detailed description
see above
- Conditions
- Crohns Disease, Ulcerative Colitis, Irritable Bowel Syndrome
- Being tested
- Integrative Therapy
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative TherapyOther
This group receives an integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Therapy | This group receives and integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy.
Patients are admitted to the hospital ward for 14 days. Receives: Other: Integrative Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms Severity IBS-SSS
Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
Measured: 2 weeks
Symptoms Severity CAI
Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)
Measured: 2 weeks
Symptoms Severity CDAI
Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
Measured: 2 weeks
Secondary outcomes (14)
Symptoms Severity IBS-SSS
Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
Measured: 24 weeks
Symptoms Severity CAI
Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)
Measured: 24 weeks
Symptoms Severity CDAI
Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
Measured: 24 weeks
Disability MYMOP
Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)
Measured: 2 weeks
Disability MYMOP
Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)
Measured: 24 weeks
Quality of Life IBS-QOL
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)
Measured: 2 weeks
Quality of Life IBS-QOL
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)
Measured: 24 weeks
Quality of Life IBDQ
Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)
Measured: 2 weeks
Quality of Life IBDQ
Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)
Measured: 24 weeks
Self efficacy questionnaire SWE
Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)
Measured: 2 weeks
Self efficacy questionnaire SWE
Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)
Measured: 24 weeks
Body awareness BAQ
Body awareness assessed by Body Awareness Questionnaire (BAQ) (Shields et al., 1989)
Measured: 24 weeks
Body awareness BRS
Body awareness assessed by Body Responsiveness Scale (BRS) (Daubenmier, 2005)
Measured: 24 weeks
Adverse effects
Number of participants with any adverse effect during the study period
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2018
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohns DiseaseStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof, MD, Principal investigator, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476643
- Sponsor's protocol ID
- 15-6183-BO InteGast
- Acronym
- InteGast
- Status last verified
- Apr 2018
- First submitted
- 12 Jun 2015
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine
- ClinicalTrials.gov ID
- NCT02476643
- Acronym / sponsor ID
- InteGast / 15-6183-BO InteGast
- Conditions
- Crohns Disease, Ulcerative Colitis, Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Jun 2015 (estimated)
- 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.
This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.
Detailed description
see above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative Therapy | – | Other: Integrative TherapyThis group receives and integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy. Patients are admitted to the hospital ward for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with Inflammentory Bowel Disease admitted to the Department of Internal and Integrative Medicine. 100 patients with Irritable Bowel Syndrome admitted to the Department of Internal and Integrative Medicine.
Key inclusion criteria (3 listed)
- 18 years or older
- diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
- written informed consent
Key exclusion criteria (1 listed)
- participation in other clinical studies
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 |
|---|---|---|
| Integrative TherapyThis group receives an integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy. | Other | Integrative Therapy |
Primary outcome
Symptoms Severity IBS-SSS
Time frame: 2 weeks
Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
Symptoms Severity CAI
Time frame: 2 weeks
Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)
Symptoms Severity CDAI
Time frame: 2 weeks
Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
14 secondary outcomes
Symptoms Severity IBS-SSS
Time frame: 24 weeks
Symptoms Severity CAI
Time frame: 24 weeks
Symptoms Severity CDAI
Time frame: 24 weeks
Disability MYMOP
Time frame: 2 weeks
Disability MYMOP
Time frame: 24 weeks
Quality of Life IBS-QOL
Time frame: 2 weeks
Quality of Life IBS-QOL
Time frame: 24 weeks
Quality of Life IBDQ
Time frame: 2 weeks
Quality of Life IBDQ
Time frame: 24 weeks
Self efficacy questionnaire SWE
Time frame: 2 weeks
Self efficacy questionnaire SWE
Time frame: 24 weeks
Body awareness BAQ
Time frame: 24 weeks
Body awareness BRS
Time frame: 24 weeks
Adverse effects
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
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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.
Gustav Dobos, Prof, MD principal investigator
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohns Disease and Ulcerative Colitis, run by Universität Duisburg-Essen at 1 site in Germany.
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 3 inclusion and 1 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 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms Severity IBS-SSS (time frame: 2 weeks). The study lists 3 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 2 May 2018; AzTrials last refreshed its copy on 26 Oct 2026.