Irritable Bowel Syndrome Spastic colon
Conditions
Interventions
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria IBS patients • A diagnosis of IBS according to Rome IV criteria, as follows: o 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; * Associated with a change in stool form (appearance). o Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. • 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. Inclusion criteria IBD patients • Patients with IBD diagnosed in accordance with current ECCO guidelines, with IBD- IBS and with chronic abdominal pain, as follows: o MIAH score <3 and/or o Fecal calprotectin < 150 ug/g o Fulfilling the Rome IV criteria for IBS. • 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.
Exclusion criteria
Exclusion criteria: 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. Patients with a clinical relevant depression or anxiety disorder will not be excluded from participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary aim: To study whether insight into personal symptom dynamics and triggers via the ESM tool and Traqq will improve treatment outcomes of any chosen treatment for abdominal pain in patients with IBS and IBD-IBS, as measured by the IBS-SSS over a 12-week time period. Primary hypothesis: We hypothesize that the IBS-SSS score will decrease at 12 weeks compared to baseline measurement in both treatment arms (standard care and ESM/Traqq) due to regular patient education and provided treatment in daily care, but that the decrease in IBS-SSS score in the ESM/Traqq arm will be greater as compared to standard care in both the IBS and IBD-IBS patients. We compare the difference in IBS-SSS score from baseline in the intervention group with the difference in IBS-SSS score from baseline in the control group. We expect a difference in the IBS-SSS score to be clinically higher, defined as >=50 points difference in IBS-SSS score, in the ESM/Traqq group compared to the standard care group for both IBS and IBD-IBS patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary aims: To explore whether the following parameters will improve more in the ESM/Traqq group compared to the standard care group, as measured at baseline and at 12 weeks after baseline: - Quality-of-life (QoL) as measured by EQ-5D-5L - Overall anxiety, as measured by GAD-7 - GI related anxiety as measured by VSI - Depressive symptoms as measured by PHQ-9 - Fatigue as measured by MFI-20 Furthermore, both patient groups, i.e. IBS and IBD-IBS, will complete the diagnostic Rome IV criteria for IBS at baseline (as an inclusion criterion) and after 12 weeks. Next to that, as there is a strong overlap between IBS and functional dyspepsia, also the Rome IV criteria for functional dyspepsia will be completed at baseline and after 12 weeks. At last, to explore whether the information out of the ESM and Traqq applications is useful in the shared decision making for an optimal intervention for the patient. Secondary hypothesis: We hypothesize that the QoL, general and GI related anxiety, depressive symptoms, overall GI symptoms, and fatigue will improve significantly after symptom dynamics and triggers are more understood and recognized by the patients in the ESM/Traqq group, when compared to the standard care groups, at 12 weeks after baseline. We expect that the information gained out of the ESM and Traqq applications can help in making the right choice for a treatment that fits the patients* needs better than in regular care. | — |
Countries
Netherlands
Contacts
Public ContactDHCA Bosch
Universiteit Maastricht
Outcome results
None listed