Development, dIagnostic and prevention of gender-related Somatic and mental COmorbitiEs in iRritable bowel syndrome In Europe

Completed

• Conditions: bowel disorder; intestinal complaints; 10017943; 10027946

• Registration Number: NL-OMON51010
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

* Signed written informed consent
* Age at least 18 years at baseline visit
* Fulfilling criteria for at least one of the comorbid conditions (checklists
in CRF):
* The psychiatric patient group (1):
* anxiety and/or depression during the MINI interview
* The somatic patient group (2) should (also) have:
* chronic fatigue syndrome according to 2015 IOM/SEID or
* fibromyalgia according to ACR criteria (2011)
* The psychiatric patient group with somatic comorbidities (3) should fulfil
both of the above diagnoses
* Ability to understand and willingness to comply with the study procedures,
and to give consent.

Exclusion Criteria

* Participation in another clinical study 1 month prior to screening visit and
throughout the study
* Abnormal results on the screening laboratory tests, clinically relevant for
study participation
* Other gastrointestinal disease(s) explaining the patient*s symptoms, as
judged by the investigator
* Other severe disease(s) such as malignancy, severe heart disease, kidney
disease or neurological disease, interfering with study evaluations
* Symptoms indicating other severe disease(s) such as gastrointestinal
bleeding, weight loss or fever
* Severe psychiatric disease, other than the comorbid conditions explicitly
studied, with necessary additional psychopharmacotherapy or psychiatric
intervention involving day-care/ inpatient treatment at start of study or
during the study, especially a diagnosis of bipolar disorder, schizophrenia,
autism spectrum disorder, schizoaffective disorder or organic psychiatric
disorder (current OR lifetime).
* Previous history of drug or alcohol abuse 6 months prior to screening
* Consumption of antibiotics 3 months prior to the baseline visit
* Pregnant or lactating at the baseline visit
* Use of probiotics in the last three months

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Physical symptoms using scores on the IBS Severity Scoring System (IBS-SSS),<br /><br>Patient Health Questionnaire-15 (PHQ-15), Multidimensional Fatigue Inventory<br /><br>(MFI) and mental symptoms using scores on the Generalized Anxiety Disorder<br /><br>7-Item Scale (GAD-7) and Patient Health Questionnaire-9 (PHQ-9). All measures<br /><br>used are identical across all study sites.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Biological materials: gut microbial profile through sequencing of bacterial DNA<br /><br>in faecal sample, intestinal permeability measured trough passage of ingested<br /><br>sugars in urine, bacterial products in blood.</p><br>