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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003477

Enrollment

400

Registered

2012-02-08

Start date

2011-06-14

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A04.3 D59.3 K58 F43.1

Interventions

Group 1: Observation group: Investigation of the Prevalence of Post Traumatic Stress disorder in patients with enterocolitis due to enterohemorrhagic escherichia coli (EHEC) with or without hemolytic

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 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.	—

Measure

Time frame

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 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.

—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactViola Andresen

Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie Universitätsklinikum Hamburg-Eppendorf

andresen@ik-h.de040-7410-53993

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026