Integrative Gastroenterology - an Observational Trial (InteGast)

April 30, 2018 updated by: Romy Lauche, Universität Duisburg-Essen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

see above

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • participation in other clinical studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptoms Severity IBS-SSS
Time Frame: 2 weeks
Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
2 weeks
Symptoms Severity CAI
Time Frame: 2 weeks
Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)
2 weeks
Symptoms Severity CDAI
Time Frame: 2 weeks
Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptoms Severity IBS-SSS
Time Frame: 24 weeks
Symptoms Severity assessed by Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (Francis, 1997)
24 weeks
Symptoms Severity CAI
Time Frame: 24 weeks
Symptoms Severity assessed by Clinical Activity Index (CAI) (Rachmilewitz 1989)
24 weeks
Symptoms Severity CDAI
Time Frame: 24 weeks
Symptoms Severity assessed by Crohn Disease Activity Index (CDAI)
24 weeks
Disability MYMOP
Time Frame: 2 weeks
Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)
2 weeks
Disability MYMOP
Time Frame: 24 weeks
Disability assessed by Measure Yourself Medical Outcome Profile (MYMOP) (Paterson 1996)
24 weeks
Quality of Life IBS-QOL
Time Frame: 2 weeks
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)
2 weeks
Quality of Life IBS-QOL
Time Frame: 24 weeks
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL) (Patrick, 1998)
24 weeks
Quality of Life IBDQ
Time Frame: 2 weeks
Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)
2 weeks
Quality of Life IBDQ
Time Frame: 24 weeks
Inflammatory Bowel Disease Questionnaire (IBDQ) (Cooney et al., 2007)
24 weeks
Self efficacy questionnaire SWE
Time Frame: 2 weeks
Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)
2 weeks
Self efficacy questionnaire SWE
Time Frame: 24 weeks
Self efficacy questionnaire (SWE) (Schwarzer and Jerusalem, 1995)
24 weeks
Body awareness BAQ
Time Frame: 24 weeks
Body awareness assessed by Body Awareness Questionnaire (BAQ) (Shields et al., 1989)
24 weeks
Body awareness BRS
Time Frame: 24 weeks
Body awareness assessed by Body Responsiveness Scale (BRS) (Daubenmier, 2005)
24 weeks
Adverse effects
Time Frame: 2 weeks
Number of participants with any adverse effect during the study period
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universität Duisburg-Essen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gustav Dobos, Prof, MD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-6183-BO InteGast

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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