Deep-phenotyping and personalized therapy of patients with irritable bowel syndrome
Organizational Data
- DRKS-ID:
- DRKS00032767
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-10-20
- Last update in DRKS:
- 2024-03-12
- Registration type:
- Prospective
Acronym/abbreviation of the study
PIONEER-IBS
URL of the study
No Entry
Brief summary in lay language
This study examines a personalized therapy for patients with irritable bowel syndrome. Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders and affects about 5-11% of the adult population worldwide. Symptoms of IBS include recurrent abdominal pain associated with an alteration of bowel habits. The disease is understood as a disturbance of the "microbiota-gut-brain axis", including changes in pain perception, emotional perception or the microbiome. Therapeutic options for IBS range from the use of medication, to dietary measures, to specific psychotherapy manuals. To date, none of the therapies have made a breakthrough in IBS. This may be explained by differences in the patients with IBS, themselves. Research has shown that patients with IBS are a very diverse group, including differences in somatic and psychic patterns and their relationship. To address these differences, this study will test a personalized therapy. For this purpose, patients with IBS will be characterized according to their psycho-somatic profile and subsequently assigned to a therapy. The patients will receive either an optimal personalized therapy, a sub-optimal personalized therapy, or an enhanced standard treatment (i.e., a control). The primary aim of the study is to assess the feasibility of personalized therapy in the treatment of IBS. The secondary aim of the study is to gain an insight into the relative effectiveness of optimal personalized therapy.
Brief summary in scientific language
This study is a pilot RCT-study for a personalized therapy for patients with IBS. The study is planned as a three-arm study: Treatment group A: Optimal personalized therapy Treatment group B: Sub-optimal personalized therapy Control: Enhanced standard treatment A psycho-somatic profile will be constructed for all participating patients using entries in an online diary initiated prior to the start of the study. In addition, somatic parameters including the microbiome, heart rate variability and pain threshold (measured with a blood pressure cuff) will be documented for all participating patients before the start, during and after the study. The primary aim of the study is to assess the feasibility of personalized therapy in the treatment of IBS. The secondary aim of the study is to gain an insight into the relative effectiveness of optimal personalized therapy.
Health condition or problem studied
- ICD10:
- F45.32
- ICD10:
- K58 - Irritable bowel syndrome
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 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 the individual patient EITHER: Group therapeutic abdominal hypnotherapy weekly for 60 min for 7 weeks OR: Individual therapeutic EMDR treatment (Eye-Movement Desensitization and Reprocessing) weekly 60 min for 7 weeks.
- Arm 2:
- Treatment group B: Sub-optimal personalized therapy Continuation of ongoing treatment with additional sub-optimal personalized therapy. Depending on and according to the psycho-somatic profile of the individual patient optimal therapies will be reversed. Those deemed best suited to group therapeutic abdominal hypnotherapy will be treated with EMDR. Conversely those deemed best suited to EMDR will be treated with Group therapeutic abdominal hypnotherapy.
- Arm 3:
- Control: Enhanced standard treatment Continuation of ongoing treatment with additional telephone counselling (once a week, 5-10 min for 7 weeks).
Endpoints
- Primary outcome:
- 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 outcome:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Using codes allocated to individual patients, a research assistant not involved in the treatment phases of the study will randomly allocate patients to individual treatment groups.
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- Stratified randomisation using computer software Stratification according to: gender, type of IBS (diarrhoea-dominant, constipation-dominant, mixed type, unspecified), psycho-somatic profile.
- Who is blinded:
-
- Data analyst
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Heidelberg 69120
- Doctor's practice 69120
Recruitment period and number of participants
- Planned study start date:
- 2023-11-27
- Actual study start date:
- 2023-11-20
- Planned study completion date:
- 2025-11-01
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 75
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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
* 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
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Heidelberg, Abteilung für Allgemeine Innere Medizin und Psychosomatik69120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Heidelberg, Abteilung für Allgemeine Innere Medizin und PsychosomatikDr. med. Felicitas EngelIm Neuenheimer Feld 410, Innere II69120 HeidelbergGermany
- Telephone:
- 06221 56 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universitätsklinikum Heidelberg, Abteilung für Allgemeine Innere Medizin und PsychosomatikDr. med. Felicitas EngelIm Neuenheimer Feld 410, Innere II69120 HeidelbergGermany
- Telephone:
- +496221 56 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universitätsklinikum Heidelberg, Abteilung für Allgemeine Innere Medizin und PsychosomatikApl. Prof. Dr. sc. hum. Beate WildIm Neuenheimer Feld 410, Innere II69120 HeidelbergGermany
- Telephone:
- +496221 56 0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Medizinische Fakultät der Universität Heidelberg (Clinician Scientist Programm)69120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Medizinische Fakultät der Universität Heidelberg (Dres. Majic/Majic-Schlez-Stiftung)69120 HeidelbergGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-5626460
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizinische-fakultaet-hd.uni-heidelberg.de/einrichtungen/zentrale-einrichtungen/ethikkommission
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-06-01
- Ethics committee number:
- S-330/2023
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-06-21
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry