Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
Condition: IBS; IBD
MeSH terms: Inflammatory Bowel Diseases; Irritable Bowel Syndrome
Study type: Interventional

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.
    

Intervention name(s): Gut-directed hypnotherapy
Intervention type(s): Other
Intervention description(s): relaxation technique with hypnotic induction and suggestions aimed at fostering sense of control, acceptance and calming of bowels.
Other intervention name(s): Gut-focused hypnotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Psychosomatics; Gastroenterology; Psychoneuroimmunology