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Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536131
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriele Moser, Medical University of Vienna

Brief Summary:
Longitudinal Investigation of intestinal microbiome, fecal inflammation markers, stress and psychological variables in patients with irritable bowel syndrome and inflammatory bowel disease undergoing gut-directed hypnotherapy (GHT).

Condition or disease Intervention/treatment Phase
IBS IBD Other: Gut-directed hypnotherapy Not Applicable

Detailed Description:

Study design is a within-subject design with assessment at 4 points in time. Data will be collected 3-1 month before first GHT session (T1), immediately before first session (T2), at the last session (T3), and 3-6 months after last session (T4).

Study patients will be recruited consecutively at the special outpatient-clinic for psychosomatics at the division of Gastroenterology and Hepatology, department for Internal Medicine III, University Hospital Vienna.

Patients undergo GHT in group setting, which has been shown to reduce irritable bowel syndrome (IBS) symptoms and to increase psychological wellbeing. The GHT protocol used will be the Manchester protocol of gut-directed hypnotherapy and consists of 10 weekly sessions (45 minutes) with six up to eight patients per group over a treatment period of 12 weeks.

The following variables will be assessed using standardized questionnaires: anxiety and depression (HADS-D), perceived stress (PSQ), resilience (CDRISC), and quality of life (visual analogue scales). IBS symptoms will be captured by the IBS Severity Scoring System (IBS-SSS), inflammatory bowel disease (IBD) disease activity via Harvey-Bradshaw-Index. Additionally, medication intake and food supplements will be assessed.

Microbiome data will be gained by frozen stool samples, collected by patients at home. Patients will be provided with a delivery kit to keep the samples frozen. Patients are asked to collect the first stool of the day and not to change diet, medication and intake of pre/probiotics during the hole study period, if possible (documented). At each time point (T1-T4) patients are ask to bring two immediately frozen (stored in their home freezer) double samples (2 stool samples within 1 week) to the hospital to be immediately stored at minus 20 degree Celsius. If patients do not have a home freezer, stool will be collected and frozen at the hospital.

Planned analyses comprise longitudinal and cross-sectional comparisons Intestinal colonization will enter in the analyses according to an algorithm assigning values for an increase or reduction of dysbiosis. Dysbiosis is hereby defined by the following markers: reduction of fecal biodiversity, lowered occurrence of the species Bifidobacterium, Lactobacillus and Faecalibacterium prausnitzi, increased occurrence of Enterobacteriaceae, and a higher quotient Firmicutes:Bacteroidetes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
Study Start Date : August 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Study group
7-10 sessions gut-directed hypnotherapy within 12 weeks
Other: Gut-directed hypnotherapy
relaxation technique with hypnotic induction and suggestions aimed at fostering sense of control, acceptance and calming of bowels.
Other Name: Gut-focused hypnotherapy




Primary Outcome Measures :
  1. Changes in gut microbiome as assessed through analyzing fecal samples [ Time Frame: 7 days ]
    Analysis of faeces by taxonomic and functional classification via 16s ribosomal ribonucleic acid (rRNA) sequencing with special regard to commensal microbiota and pathobionts

  2. Perceived Stress Questionnaire [ Time Frame: 10 days ]
  3. Hospital Anxiety and Depression Scale [ Time Frame: 7 days ]
    Total score as a measure of psychological distress


Secondary Outcome Measures :
  1. Connor-Davidson Resilience Scale [ Time Frame: 10 days ]
  2. Severity Scoring System for Irritable Bowel Syndrome [ Time Frame: 10 days ]
  3. Faecal calprotectin [ Time Frame: 1 day ]
    Intestinal inflammation marker

  4. Harvey-Bradshaw-Index [ Time Frame: 2 days ]
    Disease activity index for IBD's

  5. Quality of life visual analogue scales [ Time Frame: 10 days ]
    Visual analogue scales pertaining to physical, psychological and general wellbeing

  6. GI single symptom visual analogue scales [ Time Frame: 10 days ]


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of IBS or IBD
  • Eligible for gut-directed hypnotherapy
  • Adult age (18-89)
  • Sufficient knowledge of german language

Exclusion Criteria:

  • Severe somatic or psychiatric illness
  • Operations of the GI tract

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536131


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gabriele Moser, MD, Prof Medical University of Vienna
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabriele Moser, Prof. Dr. Gabriele Moser, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02536131    
Other Study ID Numbers: EK 1502/2014
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Keywords provided by Gabriele Moser, Medical University of Vienna:
Psychosomatics
Gastroenterology
Psychoneuroimmunology
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Colonic Diseases, Functional
Colonic Diseases