EUCTR2015-005753-12-GB进行中（未招募）1 期
Prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis. - STOP-Colitis Pilot Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Over 18 and under 50 years of age
- •2)regular morning bowel habits, which can be classified as Bristol stool chart type 2-5
- •3)normal BMI (over 18.5 and under 25)
- •4) presently be non-smokers (not smoked for the past 12 months)
- •5) provide written informed consent
- •1)Confirmed UC for at least 3 months from date of screening
- •2) Age 12-70 years
- •3) Partial Mayo score of between 4 and 8 despite stable 5ASA+/- thiopurine, methotrexate or no treatment
- •4) Rectal bleeding subscore >0
- •5) Written, signed informed consent and/or assent to the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •GI history of:
- •-inflammatory bowel disease
- •-irritable bowel syndrome, idiopathic chronic constipation or chronic diarrhoea
- •-gastrointestinal malignancy or known polyposis
- •-celiac disease
- •-congenital or chronic liver disease
- •-per rectal bleeding
- •-major gastrointestinal surgery (eg gastric bypass)
- •AUTOIMMUNE history of systemic autoimmunity including:
- •-Connective tissue disease
- •-Thyroid disease
- •-Inflammatory arthritis
- •-Psoriasis
- •ATOPIC disease inc.
- •-Atopic dermatitis
- •-Eosinophilic disorders of the gastrointestinal tract
- •CHRONIC PAIN history inc.
- •-Chronic fatigue syndrome
- •-Fibromyalgia
- •CARDIOVASCULAR history of a cardiovascular or metabolic syndrome including:
- •-Diabetes (type 1 or type 2)
- •-High blood pressure
- •-High cholesterol
- •-High fasting glucose
- •-Heart disease (eg atherosclerosis, myocardial infarction, congestive heart failure)
- •NEUROLOGICAL history of neurological conditions including:
- •-Multiple Sclerosis
- •-Parkinson’s disease
- •-Alzheimer’s disease or dementia disorders
- •IMMUNOSUPPRESSION history of any major immunosuppressive mechanisms including:
- •-Calcineurin inhibitors
- •-Exogenous glucocorticoids
- •-Biological agents
- •-Anti-TNF factors
- •-Systemic chemotherapeutic anti-neoplastic agents
- •-Transplantation (eg solid organ, bone marrow, cornea etc)
- •MENTAL HEALTH AND WELL BEING history of having been diagnosed by a clinician with any of the following:
- •-Depression
- •-Bipolar disorder
- •-Schizophrenia or delusional disorder
- •-Eating disorder (eg anorexia and / or bulimia)
- •INFECTIOUS DISEASES
- •-Known to have HIV, HBV and/or HCV infection
- •-Known to have been exposed to HIV, HBV and/or HCV in the preceding 12 months
- •-Risk of Creutzfeldt-Jakob disease (CJD) or variant CJD
- •-Originate from or share sexual partners or have a parent who originates from areas with high-incidence Human T-cell Lymphotropic Virus eg Caribbean, Japan, South America and Africa.
- •-Positive microbiology testing for any of the pathogens described donor testing schedule
- •HIGH RISK ACTIVITIES FOR BLOODBORNE INFECTIONS
- •Engaged in any known high risk activities for blood-borne infections, including:
- •-Sexual contact with an individual with known or suspected HIV, AIDS and/or hepatitis
- 另有 20 项未显示
研究者
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