IBSNCT02536131
Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
A study testing Gut-directed hypnotherapy in people with IBS and IBD, run by Medical University of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- What is being tested?
- Gut-directed hypnotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2014to Aug 2016
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IBS or IBD
- Eligible for gut-directed hypnotherapy
- Adult age (18-89)
- Sufficient knowledge of german language
Who cannot join
- Severe somatic or psychiatric illness
- Operations of the GI tract
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- Gut-directed hypnotherapy
- Keywords
- Psychosomatics, Gastroenterology, Psychoneuroimmunology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut-directed hypnotherapyOther
Also called Gut-focused hypnotherapy
relaxation technique with hypnotic induction and suggestions aimed at fostering sense of control, acceptance and calming of bowels.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | 7-10 sessions gut-directed hypnotherapy within 12 weeks Receives: Other: Gut-directed hypnotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Perceived Stress Questionnaire
Measured: 10 days
Hospital Anxiety and Depression Scale
Total score as a measure of psychological distress
Measured: 7 days
Secondary outcomes (6)
Connor-Davidson Resilience Scale
Measured: 10 days
Severity Scoring System for Irritable Bowel Syndrome
Measured: 10 days
Faecal calprotectin
Intestinal inflammation marker
Measured: 1 day
Harvey-Bradshaw-Index
Disease activity index for IBD's
Measured: 2 days
Quality of life visual analogue scales
Visual analogue scales pertaining to physical, psychological and general wellbeing
Measured: 10 days
GI single symptom visual analogue scales
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBSStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Moser, Medical University of Vienna
- Investigators
- Gabriele Moser, MD, Prof, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536131
- Sponsor's protocol ID
- EK 1502/2014
- Status last verified
- Oct 2016
- First submitted
- 21 Aug 2015
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30095672
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02536131
- Acronym / sponsor ID
- EK 1502/2014
- Keywords
- Psychosomatics, Gastroenterology, Psychoneuroimmunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 31 Aug 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Other: Gut-directed hypnotherapy7-10 sessions gut-directed hypnotherapy within 12 weeks |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of IBS or IBD
- Eligible for gut-directed hypnotherapy
- Adult age (18-89)
- Sufficient knowledge of german language
Key exclusion criteria (2 listed)
- Severe somatic or psychiatric illness
- Operations of the GI tract
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 |
|---|---|---|
| Gut-directed hypnotherapyAlso: Gut-focused hypnotherapyrelaxation technique with hypnotic induction and suggestions aimed at fostering sense of control, acceptance and calming of bowels. | Other | Study group |
Primary outcome
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
Perceived Stress Questionnaire
Time frame: 10 days
Hospital Anxiety and Depression Scale
Time frame: 7 days
Total score as a measure of psychological distress
6 secondary outcomes
Connor-Davidson Resilience Scale
Time frame: 10 days
Severity Scoring System for Irritable Bowel Syndrome
Time frame: 10 days
Faecal calprotectin
Time frame: 1 day
Harvey-Bradshaw-Index
Time frame: 2 days
Quality of life visual analogue scales
Time frame: 10 days
GI single symptom visual analogue scales
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 30095672Peter 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.
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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.
Gabriele Moser, MD, Prof principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gut-directed hypnotherapy in people with IBS and IBD, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Oct 2016. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in gut microbiome as assessed through analyzing fecal samples (time frame: 7 days). 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?
On the ClinicalTrials.gov record for NCT02536131, which also lists 1 linked publication.
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 5 Oct 2016.