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临床试验/NCT02536131
NCT02536131已完成不适用

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

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Changes in gut microbiome as assessed through analyzing fecal samples

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of IBS or IBD
  • Eligible for gut-directed hypnotherapy
  • Adult age (18-89)
  • Sufficient knowledge of german language

排除标准

  • Severe somatic or psychiatric illness
  • Operations of the GI tract

结局指标

主要结局

Changes in gut microbiome as assessed through analyzing fecal samples

时间窗: 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

时间窗: 10 days

Hospital Anxiety and Depression Scale

时间窗: 7 days

Total score as a measure of psychological distress

次要结局

  • Harvey-Bradshaw-Index(2 days)
  • Quality of life visual analogue scales(10 days)
  • Severity Scoring System for Irritable Bowel Syndrome(10 days)
  • Faecal calprotectin(1 day)
  • GI single symptom visual analogue scales(10 days)
  • Connor-Davidson Resilience Scale(10 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriele Moser

Prof. Dr. Gabriele Moser

Medical University of Vienna

研究点 (2)

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