NL-OMON47555已完成2 期
Fecal Transplantation in adolescents with refractory Irritable Bowel Syndrome - Fecal transplantation in patients with IBS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
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
- 12 至 99（—）
入选标准
- •Age 16-21 years
- •Non-smokers
- •Ability to give informed consent
- •Established irritable bowel syndrome diagnosis according to the Rome IV criteria for children or adults
- •Average daily pain rate of at least 30mm on the pain component of the IBS-SSS
- •Symptoms are present for >= 12 months
- •The patient has received adequate explanation and reassurance for his/her symptoms
- •Appropriate dietary interventions have occurred, including the normalisation of the insoluble fiber intake and a decrease in gas producing foods
- •Absence of response to a minimum of six sessions of psychological treatment (i.e. cognitive behavorial therapy and/or hypnotherapy)
- •Absence of response to an adequate dose of at least one IBS specific pharmacological agent tried for a minimum of 6 weeks (like Mebeverine or peppermint oil capsules);Donors:
- •Age >=16 years
- •Non-smokers
- •Ability to give informed consent
- •BMI 18-25 kg/m2
- •Regular stool pattern
排除标准
- •Current treatment by another health care professional for abdominal symptoms
- •Known concomitant organic gastrointestinal disease
- •Known diagnosis of inflammatory bowel disease (i.e. Crohn*s disease or ulcerative colitis)
- •Known diagnosis of an autoimmune disease (e.g. hypo- or hyperthyroidism, celiac disease, rheumatoid arthritis)
- •Known diagnosis of cystic fibrosis
- •Known diagnosis of porphyria
- •Anxiety or depression disorder
- •Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, butyl scopolamine, domperidone, peppermint oil capsules, and Iberogast
- •Known pregnancy or current lactation
- •Condition leading to profound immunosuppression
- •o For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies
- •o Use of systematic chemotherapy
- •Life expectancy < 12 months
- •Use of concomitant medication, including proton pomp inhibitors (PPI), with the exception of pain medication
- •o Pain medication in the form of Paracetamol or NSAIDs is allowed
- •Use of systemic antibiotics in preceding 6 weeks
- •Use of probiotic treatment in preceding 6 weeks
- •Positive stool culture for Helicobacter pylori
- •Positive Dual Faeces Test for Giardia lamblia, Dientamoeba fragilis, Entamoeba histolytica
- •XTC, amphetamine or cocaine abuse
- •History of surgery:
- •o Hemicolectomy (defined as: surgery resulting in a resection of > 0.5 of the colon)
- •o Presence of a pouch due to surgery
- •o Presence of stoma
- •Known intra-abdominal fistula
- •Vasopressive medication, ICU stay
- •Signs of ileus, diminished passage
- •Allergy to macrogol or substituents, e.g. peanuts, shellfish
- •Insufficient knowledge of the Dutch language;Donors:
- •Abnormal bowel motions, abdominal complaints or symptoms indicative of irritable bowel syndrome
- •An extensive travel behaviour
- •Unsafe sex practice (questionnaire)
- •Use of any medication including PPI
- •Antibiotic treatment in the past 12 weeks
- •A positive history/clinical evidence for inflammatory bowel disease (Crohn*s disease or ulcerative colitis) or other gastrointestinal diseases, including chronic diarrhoea or chronic constipation
- •A positive history/clinical evidence for autoimmune disease (type 1 diabetes, Hashimoto hypothyroidism, Graves hyperthyroidism, rheumatoid arthritis, celiac disease) and/or patients receiving immunosuppressive medications
- •History of or present malignant disease and/or patients who are receiving systemic anti-neoplastic agents
- •Psychiatric disease (depression, schizophrenia, autism, Asperger*s syndrome)
- •Chronic neurological/neurodegenerative disease (e.g. Parkinson*s disease, multiple sclerosis)
- •Predisposing factors for potential transmittable diseases (e.g. regular sexual contact with prostitutes/promiscuity)
- •Positive blood tests for the presence of: HIV, HTLV, lues, Strongyloides, amoebiasis
- •Active hepatitis A, B-, C- or E-virus infection, acute infection with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
- •Positive faecal tests for the presence of:
- •o Bacteria:
- •* Clostridium difficile, Helicobacter pylori
- •* Salmonella spp., Shigella spp., pathogenic Campylobacter spp., Yersinia enterocolitica, Aeromonas spp., Plesiomonas shigelloides
- •* Antibiotic resistant bacteria: Extended spectrum beta-lactamase (ESBL)-producin
研究者
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