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Deep-phenotyping and personalized therapy of patients with irritable bowel syndrome

Deep-phenotyping and personalized therapy of patients with irritable bowel syndrome - PIONEER-IBS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032767
Enrollment
75
Registered
2023-10-20
Start date
2023-11-20
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

F45.32 K58

Interventions

Group 1: Treatment group A: Optimal personalized therapy Continuation of ongoing treatment with additional optimal personalized therapy. Depending on and according to the psycho-somatic profile of t

Sponsors

Universitätsklinikum Heidelberg, Abteilung für Allgemeine Innere Medizin und Psychosomatik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: * Irritable bowel syndrome according to ROM-IV criteria, * Irritable bowel syndrome in clinical assessment, * Patients who agree to participate in the study for at least 5 months, * Written informed consent

Exclusion criteria

Exclusion criteria: * Severe psychopathology preventing group therapy (e.g. acute schizophrenic disorder, acute suicidality, current substance dependence (alcohol/drugs)). * Psychopathology preventing short-term EMDR treatment (e.g. severe dissociative symptoms (DES-II >25%), complex post-traumatic stress disorder). * Severe comorbid organic disorder preventing participation (e.g. palliative terminal cancer, serious nephrological, hepatic, cardiovascular or neurological disease). *Pregnancy

Design outcomes

Primary

MeasureTime frame
Feasibility of the study at the end of treatment The feasibility criterion is considered to be met if a sufficient number of patients agree to participate in the study and if 70% of the original participants remain part of the study until its conclusion.

Secondary

MeasureTime frame
An insight in the effectiveness of optimized personalized therapy will be gained according to the following: • Simultaneous and time-depended relationships between somatic and psychological parameters during the study and at follow-up, measured according to entries in online diaries. • Reduction of symptom severity and illness anxiety measured by IBS-SSS (irritable bowel syndrome severity scoring system) and WI-7 (whiteley index 7) in pre-post comparison and at follow-up. • Improvement in quality of life, measured according to the FDD-Qol (Functional Digestive Disorders Quality of Life) in pre-post comparison and at follow-up. • Reduction in anxiety and depression-related symptoms, measured according to the PHQ-9 (Patient Health Questionnaire 9) and the GAD-7 (Generalized Anxiety Disorder 7) in pre-post comparison and at follow-up. • Change in somatic parameters (microbiome, heart rate variability, pain threshold) in pre-post comparison and at follow-up.

Countries

Germany

Contacts

Public ContactFelicitas Engel

Universitätsklinikum Heidelberg, Abteilung für Allgemeine Innere Medizin und Psychosomatik

Pioneer.zpm@med.uni-heidelberg.de+496221 56 0

Outcome results

None listed

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