Intestinal Microbiome and Psychological Correlates in Irritable Bowel Syndrome and Inflammatory Bowel Disease
1 other identifier
interventional
80
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 21, 2015
CompletedFirst Posted
Study publicly available on registry
August 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 5, 2016
October 1, 2016
2 years
August 21, 2015
October 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
7 days
Perceived Stress Questionnaire
10 days
Hospital Anxiety and Depression Scale
Total score as a measure of psychological distress
7 days
Secondary Outcomes (6)
Connor-Davidson Resilience Scale
10 days
Severity Scoring System for Irritable Bowel Syndrome
10 days
Faecal calprotectin
1 day
Harvey-Bradshaw-Index
2 days
Quality of life visual analogue scales
10 days
- +1 more secondary outcomes
Study Arms (1)
Study group
OTHER7-10 sessions gut-directed hypnotherapy within 12 weeks
Interventions
relaxation technique with hypnotic induction and suggestions aimed at fostering sense of control, acceptance and calming of bowels.
Eligibility Criteria
You may qualify if:
- Diagnosis of IBS or IBD
- Eligible for gut-directed hypnotherapy
- Adult age (18-89)
- Sufficient knowledge of german language
You may not qualify if:
- Severe somatic or psychiatric illness
- Operations of the GI tract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Related Publications (1)
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.
PMID: 30095672DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriele Moser, MD, Prof
Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Gabriele Moser
Study Record Dates
First Submitted
August 21, 2015
First Posted
August 31, 2015
Study Start
August 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 5, 2016
Record last verified: 2016-10