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OpenTrials
Completed

NCT Number: NCT02536131

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

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).

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gut-directed Hypnotherapy

Other

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

Other names: Gut-focused hypnotherapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 31, 2015
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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