NL-OMON33644招募中不适用
The effect of serotonergic modulation on intestinal permeability and visceral perception in healthy individuals and IBS patients - Serotonin intervention
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •IBS-patients
- •1) IBS will be diagnosed according to the Rome III criteria*:
- •Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following:
- •Improvement with defecation
- •Onset associated with a change in frequency of stool
- •Onset associated with a change in form (appearance) of stool
- •* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- •* Discomfort means an uncomfortable sensation not described as pain. In pathophysiological research and clinical trails, a pain/discomfort frequency of at least 2 days a week during screening evaluation is an indication for subject*s eligibility.;2) Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined.
- •3) Age between 18 and 65 years;Healthy individuals
- •1) Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- •2) Age between 18 and 65 years
排除标准
- •Exclusion criteria for IBS patients:;1) History of psychiatric disorders including use of psychoactive medication or psychological symptomatology, defined as a diagnosis on the global severity index score on SCL-90 for females >=150, for males >=131, or HADS scores >= 8. First-degree family members with psychiatric disorders
- •2) Inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, psylliumsead (metamucil), duspatal, metoclopramide, domperidon, erytromycine), or serotonin metabolism (carbidopa, food supplementation) for at least 3 days before tests.
- •3) Administration of investigational drugs in the 180 days prior to the study
- •4) Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- •5) Premenstrual syndrome, dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic), pregnancy, lactation
- •6) Excessive alcohol consumption (>20 alcoholic consumption per week)
- •7) Smoking
- •8) Blood donation within 3 months before the study period
- •9) Self-admitted HIV-positive state
- •10) Irregular day-night rhythm;Exclusion criteria for healthy individuals:
- •1) History of psychiatric disorders including use of psychoactive medication or psychological symptomatology, defined as a diagnosis on the global severity index score on SCL-90 for females >=150, for males >=131, or HADS scores >= 8
- •First-degree family members with psychiatric disorders
- •2) Use of medication, except oral contraceptives, within 14 days prior to testing
- •3) Administration of investigational drugs in the 180 days prior to the study
- •4) Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy allowed, and other surgery upon judgement of principle investigator)
- •5) Premenstrual syndrome, dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic), pregnancy, lactation
- •6) Excessive alcohol consumption (>20 alcoholic consumption per week)
- •7) Smoking
- •8) Blood donation within 3 months before the study period
- •9) Self-admitted HIV-positive state
- •10) Irregular day-night rhythm
研究者
相似试验
已完成
不适用
The Effect of Serotonergic Modulation on Intestinal Permeability and Visceral Hypersensitivity in Healthy Individuals and Irritable Bowel Syndrome (IBS) PatientsIrritable Bowel SyndromeNCT00731003Maastricht University Medical Center60
进行中（未招募）
1 期
Involvement of the serotonergic system in the control of impulsivity in Tourette disorder : ARITEPTourette disorderMedDRA version: 20.0Level: LLTClassification code: 10018271Term: Gilles de la Tourette's disorder Class: 10010331CTIS2023-506370-13-00Hospices Civils De Lyon20
进行中（未招募）
不适用
Effect of Serotonergic Stimulation on the Gut-brain AxisHealthyIrritable Bowel SyndromeNCT03920410Örebro University, Sweden58
已完成
不适用
The effect of a serotonin in the enteric canal to NK activity by oral administration of Aureobasidium pullulanse induced beta glucan, and dose-dependency of the glucan in this effect.Healthy volunteerJPRN-UMIN000012761Kochi University36
招募中
不适用
Serotonergic modulation of population receptive fieldsThere is no specific disease being investigatedNL-OMON54157Spinoza Centre for Neuroimaging40