NL-OMON51010已完成不适用
Development, dIagnostic and prevention of gender-related Somatic and mental COmorbitiEs in iRritable bowel syndrome In Europe - DISCOvERIE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •* Signed written informed consent
- •* Age at least 18 years at baseline visit
- •* Fulfilling criteria for at least one of the comorbid conditions (checklists
- •* 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.
排除标准
- •* 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
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