Irritable Bowel SyndromePERCEPTIvENCT05998577
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome
A study testing ESM and Traqq in people with Irritable Bowel Syndrome and Inflammatory Bowel Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Apart from its use to provide insight in IBS disease courses and in clinical research, ESM can provide patients with feedback about individual triggers of their symptoms, and thereby function as part of a personalized therapeutic strategy. This is also true for IBD-IBS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- ESM and Traqq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 May 2023to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- Age between 18 and 80 years;
- Ability to understand and speak the Dutch language
- Ability to understand how to utilize the ESM and Traqq applications.
- Patients with IBD diagnosed in accordance with current ECCO guidelines, with IBD- IBS and with chronic abdominal pain, as follows:
- MIAH score <3 and/or
- Fecal calprotectin < 150 ug/g or negative IUS or colonoscopy and
- Fulfilling the Rome IV criteria for IBS.
- Age between 18 and 80 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Apart from its use to provide insight in IBS disease courses and in clinical research, ESM can provide patients with feedback about individual triggers of their symptoms, and thereby function as part of a personalized therapeutic strategy. This is also true for IBD-IBS. Treatment strategies in IBS and IBD-IBS are largely based on reassurance, identification and elimination of triggering factors, and in more severe cases pharmaco- and psychotherapy. The ESM approach has the potential to increase therapeutic efficacy in IBS and IBD-IBS and will assist patients in disease self-management. The Traqq application can provide more detailed information about the dietary pattern of IBS and IBD-IBS patients. Traqq in combination with ESM will give an overview of abdominal pain and associated symptoms and psychosocial factors are exposed to during the day. The insight provided using ESM and Traqq may improve patient understanding of their personal symptom dynamics and triggers, as well as the physician's insight into the symptom patters of the specific patients, which may aid treatment choice and eventually improve the outcome of any treatment provided in daily clinical care.
Read the 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.
- Conditions
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Functional Gastrointestinal Disorders, Lifestyle Factors
- Being tested
- ESM and Traqq
- Keywords
- Experience Sampling Method, Traqq
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESM and TraqqDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| ESM/Traqq | Experimental | 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. Receives: Device: ESM and Traqq |
| Standard care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome- Symptom Severity Score (IBS-SSS)
Change in IBS-SSS to see whether IBS symptoms are improved
Scale 0-500 A higher score means worse outcome
Measured: 12 weeks after outpatient clinic visit
Secondary outcomes (5)
General Anxiety Disorder-7 (GAD-7)
Change in GAD-7 to see whether complaints of anxiety are improved
Scale 0-21 A higher score means worse outcome
Measured: 12 weeks after outpatient clinic visit
Multidimensional Fatigue Inventory-20 (MFI-20)
Change in MFI-20 to see whether fatigue is improved
Scale 20-100 A higher score means worse outcome
Measured: 12 weeks after outpatient clinic visit
Patient Health Questionnaire-9 (PHQ-9)
Change in PHQ-9 to see whether complaints of depression are improved
Scale 0-27 A higher score means worse outcome
Measured: 12 weeks after outpatient clinic visit
Visceral Sensitivity Index (VSI)
Change in VSI to see whether complaints of GI related anxiety are improved
Scale 0-75 A higher score means worse outcome
Measured: 12 weeks after outpatient clinic visit
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Change in EQ-5D-5L to see whether quality of life is improved
Scale 5-25 A higher score means worse outcome
Measured: 12 weeks after outpatient clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start19 May 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998577
- Sponsor's protocol ID
- NL82286.068.22
- Acronym
- PERCEPTIvE
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All research data will be saved as an SPSS file with all available metadata such as variables, value labels and definitions of missing data in accordance with the existing codebooks. In addition, the research data will be saved as csv files. After completion of the study, the data will be archived and the data will be stored in accordance with the required format of the relevant data archive.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05998577
- Acronym / sponsor ID
- PERCEPTIvE / NL82286.068.22
- Conditions
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Functional Gastrointestinal Disorders, Lifestyle Factors
- Keywords
- Experience Sampling Method, Traqq
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Apart from its use to provide insight in IBS disease courses and in clinical research, ESM can provide patients with feedback about individual triggers of their symptoms, and thereby function as part of a personalized therapeutic strategy. This is also true for IBD-IBS. Treatment strategies in IBS and IBD-IBS are largely based on reassurance, identification and elimination of triggering factors, and in more severe cases pharmaco- and psychotherapy. The ESM approach has the potential to increase therapeutic efficacy in IBS and IBD-IBS and will assist patients in disease self-management. The Traqq application can provide more detailed information about the dietary pattern of IBS and IBD-IBS patients. Traqq in combination with ESM will give an overview of abdominal pain and associated symptoms and psychosocial factors are exposed to during the day. The insight provided using ESM and Traqq may improve patient understanding of their personal symptom dynamics and triggers, as well as the physician's insight into the symptom patters of the specific patients, which may aid treatment choice and eventually improve the outcome of any treatment provided in daily clinical care.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESM/Traqq | Experimental | Device: ESM and TraqqUse 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. |
| Standard care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- A diagnosis of IBS according to Rome IV criteria, as follows:
- Minimal baseline score of 150 points on the IBS-SSS scale
- Age between 18 and 80 years;
- Ability to understand and speak the Dutch language
- Ability to understand how to utilize the ESM and Traqq applications.
Key exclusion criteria (6 listed)
- 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.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESM and TraqqTwo 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) | Device | ESM/Traqq |
Primary outcome
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
5 secondary outcomes
General Anxiety Disorder-7 (GAD-7)
Time frame: 12 weeks after outpatient clinic visit
Multidimensional Fatigue Inventory-20 (MFI-20)
Time frame: 12 weeks after outpatient clinic visit
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 weeks after outpatient clinic visit
Visceral Sensitivity Index (VSI)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. All research data will be saved as an SPSS file with all available metadata such as variables, value labels and definitions of missing data in accordance with the existing codebooks. In addition, the research data will be saved as csv files. After completion of the study, the data will be archived and the data will be stored in accordance with the required format of the relevant data archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESM and Traqq in people with Irritable Bowel Syndrome and Inflammatory Bowel Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome- Symptom Severity Score (IBS-SSS) (time frame: 12 weeks after outpatient clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.