CClinicalTrials.gg
Status unknownNCT02476643InteGastUpdated May 2, 2018

Integrative Gastroenterology - an Observational Trial

An observational study in Crohns Disease, Ulcerative Colitis and Irritable Bowel Syndrome, sponsored by Universität Duisburg-Essen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-02.

Sponsored by Universität Duisburg-Essen · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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 complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.

Read the detailed description

see above

02

Conditions studied

  • Crohns Disease
  • Ulcerative Colitis
  • Irritable Bowel Syndrome
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 200 is above the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Universität Duisburg-Essen is the lead sponsor of 82 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 18 years or older
  • diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • participation in other clinical studies
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Integrative Therapy

Interventions

  • OtherIntegrative Therapy

    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.

06

What researchers measure

Primary outcomes

  1. Symptoms Severity IBS-SSS

    Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)

    Time frame: 2 weeks

  2. Symptoms Severity CAI

    Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)

    Time frame: 2 weeks

  3. Symptoms Severity CDAI

    Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)

    Time frame: 2 weeks

Secondary outcomes

  1. Symptoms Severity IBS-SSS

    Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)

    Time frame: 24 weeks

  2. Symptoms Severity CAI

    Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)

    Time frame: 24 weeks

  3. Symptoms Severity CDAI

    Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)

    Time frame: 24 weeks

  4. Disability MYMOP

    Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)

    Time frame: 2 weeks

  5. Disability MYMOP

    Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)

    Time frame: 24 weeks

  6. Quality of Life IBS-QOL

    Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)

    Time frame: 2 weeks

  7. Quality of Life IBS-QOL

    Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)

    Time frame: 24 weeks

  8. Quality of Life IBDQ

    Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)

    Time frame: 2 weeks

  9. Quality of Life IBDQ

    Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)

    Time frame: 24 weeks

  10. Self efficacy questionnaire SWE

    Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)

    Time frame: 2 weeks

  11. Self efficacy questionnaire SWE

    Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)

    Time frame: 24 weeks

  12. Body awareness BAQ

    Body awareness assessed by Body Awareness Questionnaire (BAQ) (Shields et al., 1989)

    Time frame: 24 weeks

  13. Body awareness BRS

    Body awareness assessed by Body Responsiveness Scale (BRS) (Daubenmier, 2005)

    Time frame: 24 weeks

  14. Adverse effects

    Number of participants with any adverse effect during the study period

    Time frame: 2 weeks

07

Study locations

1 site
  • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
    Essen, 45276, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02476643
Lead sponsor
Universität Duisburg-Essen
Responsible party
Romy Lauche (Principal Investigator, Universität Duisburg-Essen) — Principal investigator
First posted
Jun 19, 2015
Start date
Oct 2015
Primary completion
Apr 2018
Completion
Dec 2018 (estimated)
Last update
May 2, 2018

Study contacts

Gustav Dobos, Prof, MD
principal investigator · Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion