Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
Primary Purpose
IBS, IBD
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Gut-directed hypnotherapy
Sponsored by
About this trial
This is an interventional basic science trial for IBS focused on measuring Psychosomatics, Gastroenterology, Psychoneuroimmunology
Eligibility 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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study group
Arm Description
7-10 sessions gut-directed hypnotherapy within 12 weeks
Outcomes
Primary Outcome Measures
Changes in gut microbiome as assessed through analyzing fecal samples
Analysis of faeces by taxonomic and functional classification via 16s ribosomal ribonucleic acid (rRNA) sequencing with special regard to commensal microbiota and pathobionts
Perceived Stress Questionnaire
Hospital Anxiety and Depression Scale
Total score as a measure of psychological distress
Secondary Outcome Measures
Connor-Davidson Resilience Scale
Severity Scoring System for Irritable Bowel Syndrome
Faecal calprotectin
Intestinal inflammation marker
Harvey-Bradshaw-Index
Disease activity index for IBD's
Quality of life visual analogue scales
Visual analogue scales pertaining to physical, psychological and general wellbeing
GI single symptom visual analogue scales
Full Information
NCT ID
NCT02536131
First Posted
August 21, 2015
Last Updated
October 4, 2016
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02536131
Brief Title
Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
Official Title
Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS, IBD
Keywords
Psychosomatics, Gastroenterology, Psychoneuroimmunology
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Other
Arm Description
7-10 sessions gut-directed hypnotherapy within 12 weeks
Intervention Type
Other
Intervention Name(s)
Gut-directed hypnotherapy
Other Intervention Name(s)
Gut-focused hypnotherapy
Intervention Description
relaxation technique with hypnotic induction and suggestions aimed at fostering sense of control, acceptance and calming of bowels.
Primary Outcome Measure Information:
Title
Changes in gut microbiome as assessed through analyzing fecal samples
Description
Analysis of faeces by taxonomic and functional classification via 16s ribosomal ribonucleic acid (rRNA) sequencing with special regard to commensal microbiota and pathobionts
Time Frame
7 days
Title
Perceived Stress Questionnaire
Time Frame
10 days
Title
Hospital Anxiety and Depression Scale
Description
Total score as a measure of psychological distress
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Connor-Davidson Resilience Scale
Time Frame
10 days
Title
Severity Scoring System for Irritable Bowel Syndrome
Time Frame
10 days
Title
Faecal calprotectin
Description
Intestinal inflammation marker
Time Frame
1 day
Title
Harvey-Bradshaw-Index
Description
Disease activity index for IBD's
Time Frame
2 days
Title
Quality of life visual analogue scales
Description
Visual analogue scales pertaining to physical, psychological and general wellbeing
Time Frame
10 days
Title
GI single symptom visual analogue scales
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Moser, MD, Prof
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
30095672
Citation
Peter J, Fournier C, Durdevic M, Knoblich L, Keip B, Dejaco C, Trauner M, Moser G. A Microbial Signature of Psychological Distress in Irritable Bowel Syndrome. Psychosom Med. 2018 Oct;80(8):698-709. doi: 10.1097/PSY.0000000000000630.
Results Reference
derived
Learn more about this trial
Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
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