- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05998577
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome (PERCEPTIvE)
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome and Inflammatory Bowel Disease Using Experience Sampling Method (ESM) and a Digital Food Diary (Traqq)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is an unicenter, prospective, proof-of-concept randomized controlled, non-blinded intervention study that focuses on two patient populations, with overlapping symptom patterns and treatment approaches, i.e. patients with IBS and IBD-IBS.
Following written informed consent, the eligibility screening is performed and instructions about the study procedures will be given. Hereafter, both groups will independently be randomized into i) an ESM/Traqq arm or ii) a standard care arm. The intervention group and the control group will complete the IBS-SSS, EO-5D-5L, GAD-7, PHQ-9, VSI, and MFl-20 as well as the Rome IV criteria for IBS and functional dyspepsia at baseline and the intervention group will complete thereafter the ESM and Traqq applications during the first week. After this week, the data will be analysed to identify associations between abdominal pain and psychosocial factors, diet or other GI associated symptoms. About two weeks later, participants will have their second visitation at the outpatient clinic with their treating physician. In the intervention group, but not the control group, the patient and the treating physician will receive the results of the personal data of the patients based on ESM and Traqq. The insight participants and their physicians get from this information, will help them to make changes in lifestyle factors that affect their symptoms or to choose a pharmacological or non-pharmacological treatment. However, the study protocol will not indicate which treatment choice should be made by the patient and their treating physicians. That choice will still be based on shared decision making, just as in the standard care arm, only with the additional data provided. Furthermore, if the patients are referred to a dietician, psychologist, or both, the digital data obtained in the intervention group can be used to personalize the therapy. After giving informed consent by the participant for the data of ESM and Traqq being sent to the dietician or psychologist they are referred to, the coordinating investigator will send the data digitally to the dietician or psychologist that is needed for the personalized treatment. Participants in the control arm will get a consultation with the gastroenterologist as usual after the same period of time as the intervention group get their consultation. The participants of the control group will be given treatment advice only based on this consultation, the PDSkeuzehulp by shared decision making, according to standard care. Twelve weeks after the second outpatient visit, independently of the chosen treatment approach, the participants in both study groups will be asked to complete IBS-SSS, EQ-5D-5L, GAD-7, PHO-9, VSI, MFI-20 and Rome IV criteria for IBS and functional dyspepsia for the second time to evaluate whether there is an effect on 1) reduction of abdominal pain and 2) quality of life, psychological aspects or fatigue of the participants due to the insight provided by ESM and Traqq.
After those twelve weeks, the coordinating investigator will contact the participants of the intervention group and control group by phone for the last time. Participants are asked what treatment they have gotten and what lifestyle modifications they have done to reduce abdominal pain. To improve compliance for completing the questionnaires by the control group, the participants in the control group will get the opportunity to use the ESM and Traqq applications after the study has been completed. This will not be part of this study but can be beneficial for those individuals who have not got any additional insight about their symptoms by getting the standard care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daan Bosch, BSc
- Phone Number: 0433-884295
- Email: daan.bosch@maastrichtuniversity.nl
Study Contact Backup
- Name: Zlatan Mujagic, MD, PhD
- Phone Number: 0433-875021
- Email: z.mujagic@maastrichtuniversity.nl
Study Locations
-
-
Limburg
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Maastricht, Limburg, Netherlands, 6229HX
- Recruiting
- Maastricht UMC+
-
Contact:
- Daan Bosch, BSc
- Phone Number: 0433-884295
- Email: daan.bosch@maastrichtuniversity.nl
-
Contact:
- Zlatan Mujagic, MD, PhD
- Phone Number: 0433-875021
- Email: z.mujagic@maastrichtuniversity.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria IBS patients
A diagnosis of IBS according to Rome IV criteria, as follows:
- Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria:
- Related to defecation;
- Associated with a change in stool frequency; oAssociated with a change in stool form (appearance).
- Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- Minimal baseline score of 150 points on the IBS-SSS scale
- Age between 18 and 70 years;
- Ability to understand and speak the Dutch language
- Ability to understand how to utilize the ESM and Traqq applications.
Inclusion criteria IBD patients
Patients with IBD diagnosed in accordance with current ECCO guidelines, with IBD- IBS and with chronic abdominal pain, as follows:
- MIAH score <3
- Fecal calprotectin < 150 ug/g
- Fulfilling the Rome IV criteria for IBS.
- Age between 18 and 70 years;
- Minimal baseline score of 150 points on the IBS-SSS scale
- Ability to understand and speak the Dutch language
- Ability to understand how to utilize the ESM and Traqq applications.
Exclusion criteria IBS patients
- Any organic explanation for the abdominal symptoms;
- A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy is present;
- Pregnant or lactating at the baseline visit.
Exclusion criteria IBD patients
- Uncertainty about the absence of active inflammation
- Uncertainty about other explanatory causes for the GI symptoms, such as bile acid malabsorption, intestinal stenosis, or small intestinal bacterial overgrowth;
- Pregnant or lactating at the baseline visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ESM/Traqq
Use of ESM and Traqq for one week to get a personalised analysis of the abdominal pain and triggerfactors that can be used at the outpatient clinic visit to select an effective treatment option.
|
Two telephone applications: ESM is a psychosocial diary and Traqq is a food diary to measure abdominal pain as well as possible triggerfactors (i.e.
diet, stress, anxiety)
|
No Intervention: Standard care
Will not be using ESM and Traqq, but will only get a standard outpatient clinic visit together with PDSkeuzehulp to make a decision for a treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Irritable Bowel Syndrome- Symptom Severity Score (IBS-SSS)
Time Frame: 12 weeks after outpatient clinic visit
|
Change in IBS-SSS to see whether IBS symptoms are improved Scale 0-500 A higher score means worse outcome |
12 weeks after outpatient clinic visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Anxiety Disorder-7 (GAD-7)
Time Frame: 12 weeks after outpatient clinic visit
|
Change in GAD-7 to see whether complaints of anxiety are improved Scale 0-21 A higher score means worse outcome |
12 weeks after outpatient clinic visit
|
Multidimensional Fatigue Inventory-20 (MFI-20)
Time Frame: 12 weeks after outpatient clinic visit
|
Change in MFI-20 to see whether fatigue is improved Scale 20-100 A higher score means worse outcome |
12 weeks after outpatient clinic visit
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 12 weeks after outpatient clinic visit
|
Change in PHQ-9 to see whether complaints of depression are improved Scale 0-27 A higher score means worse outcome |
12 weeks after outpatient clinic visit
|
Visceral Sensitivity Index (VSI)
Time Frame: 12 weeks after outpatient clinic visit
|
Change in VSI to see whether complaints of GI related anxiety are improved Scale 0-75 A higher score means worse outcome |
12 weeks after outpatient clinic visit
|
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Time Frame: 12 weeks after outpatient clinic visit
|
Change in EQ-5D-5L to see whether quality of life is improved Scale 5-25 A higher score means worse outcome |
12 weeks after outpatient clinic visit
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Disease
- Signs and Symptoms, Digestive
- Gastroenteritis
- Colonic Diseases, Functional
- Colonic Diseases
- Syndrome
- Irritable Bowel Syndrome
- Inflammatory Bowel Diseases
- Abdominal Pain
- Crohn Disease
- Gastrointestinal Diseases
- Digestive System Diseases
- Intestinal Diseases
Other Study ID Numbers
- NL82286.068.22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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