Post-infectious Irritable Bowel Syndrome and Post Traumatic Stress disorder in patients with EHEC/HUS disease: a cohort study with prospective follow-up

Conditions: A04.3
D59.3
K58
F43.1
Enterohaemorrhagic Escherichia coli infection
Haemolytic-uraemic syndrome
Irritable bowel syndrome
Post-traumatic stress disorder

Registration Number: DRKS00003477

Lead Sponsor: Institut und Poliklinik für Psychosomatische Medizin und PsychotherapieUniversitätsklinikum Hamburg-Eppendorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 417

Inclusion Criteria

Infection with EHEC -strain O104:H4
Presentation in in the university hospital of Hamburg or in any one of the participating hospitals with clinically diagnosed EHEC/HUS disease
Minimum age of 18 years
Written informed consent

Exclusion Criteria

Acute medical or psychological symptoms, which require immediate medical intervention (such as suicidal tendency or requiring intensive care treatment)
Knowledge of German language does not suffice to understand and sign the informed consent or to fill in the study questionnaires

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Post-infectious Irritable Bowel Syndrome (PI-IBS) (K58), assessed by ROME III questionnaire (Andresen et al., 2008 u. 2009), 6 months after EHEC/HUS disease compared with a historic control group of patients with traveller’s diarrhea<br>Prevalence of Post-traumatic stress disorder (PTBS) (F43.1), assessed by PDS questionnaire (Foa et al., 1997; dt. Version: Griesel et al., 2006) and validated by SKID interview (Wittchen et al., 1997), 6 months after EHEC/HUS disease compared with a historic control group of 965 patients treated by their general physician.<br>

Secondary Outcome Measures

Name	Time	Method
Multivariate analyses to identify variables that predict the development of a) PI-IBS (K58) and b) post-traumatic stress disorder (PTBS) (F43.1) in patients 6 months after EHEC/HUS disease, specifically: a) female gender, younger age, previous psychological illness, duration of EHEC/HUS disease, bloody diarrhea, abdominal pain, fever, weight loss, anxiety, and b) pre-traumatic factors such as female gender, younger age, low education, previous trauma, family history of psychological illness, peri-traumatic factors during EHEC/HUS disease such as severety of EHEC/HUS-illness, necessitiy of intensive care unit-treatment, peri-traumatic emotional stress, peritraumatic dissociation, subjective feeling of life-threatening disease as well as post-truamtic factos such as chronic stress or lack of social support.