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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02536131
Enrollment
80
Registered
2015-08-31
Start date
2014-08-31
Completion date
2016-08-31
Last updated
2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD, IBS

Keywords

Psychosomatics, Gastroenterology, Psychoneuroimmunology

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.

Interventions

relaxation technique with hypnotic induction and suggestions aimed at fostering sense of control, acceptance and calming of bowels.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in gut microbiome as assessed through analyzing fecal samples7 daysAnalysis of faeces by taxonomic and functional classification via 16s ribosomal ribonucleic acid (rRNA) sequencing with special regard to commensal microbiota and pathobionts
Perceived Stress Questionnaire10 days
Hospital Anxiety and Depression Scale7 daysTotal score as a measure of psychological distress

Secondary

MeasureTime frameDescription
Harvey-Bradshaw-Index2 daysDisease activity index for IBD's
Connor-Davidson Resilience Scale10 days
GI single symptom visual analogue scales10 days
Quality of life visual analogue scales10 daysVisual analogue scales pertaining to physical, psychological and general wellbeing
Severity Scoring System for Irritable Bowel Syndrome10 days
Faecal calprotectin1 dayIntestinal inflammation marker

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026