A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome

NCT05998577 | Unknown DMC

• 1 other identifier: NL82286.068.22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Functional Gastrointestinal Disorders; Lifestyle Factors

Keywords

Experience Sampling Method; Traqq

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks after outpatient clinic visit

Secondary Outcomes (5)

• General Anxiety Disorder-7 (GAD-7)

  12 weeks after outpatient clinic visit

• Multidimensional Fatigue Inventory-20 (MFI-20)

  12 weeks after outpatient clinic visit

• Patient Health Questionnaire-9 (PHQ-9)

  12 weeks after outpatient clinic visit

• Visceral Sensitivity Index (VSI)

  12 weeks after outpatient clinic visit

• European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)

  12 weeks after outpatient clinic visit

Study Arms (2)

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.

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.

Interventions

ESM and Traqq DEVICE

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)

ESM/Traqq

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases; Gastroenteritis; Colitis

Central Study Contacts

Daan Bosch, BSc

CONTACT

0433-884295; daan.bosch@maastrichtuniversity.nl

Zlatan Mujagic, MD, PhD

CONTACT

0433-875021; z.mujagic@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: May 19, 2023
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

NL (1)