bowel disorder intestinal complaints
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical symptoms using scores on the IBS Severity Scoring System (IBS-SSS), Patient Health Questionnaire-15 (PHQ-15), Multidimensional Fatigue Inventory (MFI) and mental symptoms using scores on the Generalized Anxiety Disorder 7-Item Scale (GAD-7) and Patient Health Questionnaire-9 (PHQ-9). All measures used are identical across all study sites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biological materials: gut microbial profile through sequencing of bacterial DNA in faecal sample, intestinal permeability measured trough passage of ingested sugars in urine, bacterial products in blood. | — |
Countries
Netherlands
Outcome results
None listed