Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection (CDI) in Pediatric and Young Adult Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Resolution of C. difficile
研究概览
简要总结
C-diff infection often causes belly pain and diarrhea and can be very hard to treat with medicine. One of the possible reasons that C-diff infection is hard to treat is because there is too much "bad" bacteria in the colon. Investigators believe that putting more "good" bacteria into the colon will help fight the "bad" bacteria. We do this by doing a fecal (poop) transplant.
Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital. Since our Investigators have not done this before, this study will help us learn the best way to do the transplant. Investigators also believe this transplant might help improve symptoms for patients with C-diff.
详细描述
Visit 1 - screening visit: This visit will take about 1 hour. The study doctor will talk to the patient about C-diff infection and fecal transplant in detail. Investigators will ask you questions about your medical history and health. A complete physical examination will be done. Investigators will order a pregnancy test (for girls who are old enough to become pregnant) and take blood (about 1.5 teaspoons) to make sure you do not have any other illness or infections (other than C-diff.) If the pregnancy test comes back positive on a patient who is younger than age 18, both the patient and parent(s) will be informed. The study doctor will then choose a possible stool donor. The study doctor will ask the donor to fill out a questionnaire about their medical history, past and present diseases, allergies and medications. If this donor seems suitable, blood and stool tests will be performed on the donor.
Before the next visit: Before the fecal transplant is scheduled the study doctor will look at your all of the lab results from you and the donor to make sure it is safe for the fecal transplant to take place. This will take up to two weeks. If the donor is not a suitable donor, another donor will be chosen. Every possible donor will need to sign a consent form and fill out questionnaires. When a suitable donor is found, we will to schedule the fecal transplant.
There are two ways in which the fecal transplant can be given. One is by enema and the other is during a colonoscopy. The study doctor believes that the best way to give the transplant is during a colonoscopy. If you needs to have a colonoscopy done for clinical purposes (in the routine medical care of your C-diff infection), the fecal transplant will happen during that procedure. The doctor will explain the colonoscopy to you in detail and will be given special instructions on how to prepare for the colonoscopy. You will need to sign a separate consent for the colonoscopy. The other way the fecal transplant can be given is by enema. If you are not having a colonoscopy or for some other reason the doctor believes it is better to do so, you will receive the transplant through an enema.
The study doctor will talk with you about stopping medicines that are not allowed during the study. If you are taking antibiotics (such as metronidazole, vancomycin, or rifaximin, nitazoxanide, and fidaxomicin) as a treatment for C-diff, you will be asked to stop these medicines 2 days before the transplant.
Visit 2 - the day of the fecal transplant: This visit will take about 4-6 hours. A pregnancy test will be repeated. If the pregnancy test comes back positive for a patient who is younger than age, both the patient and parent will be informed. The study doctor will ask you and the donor how they are feeling. If either the patient or the donor is not feeling well, the transplant will be reschedule to another day. If both are well, the fecal transplant will proceed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient inclusion criteria:
- •Documented laboratory-confirmed clostridium difficile infection
- •Documentation of ongoing diarrhea at time of recruitment
- •Children ≥2 years old, <18 years old; young adults >18 years old, <21 years old
- •Undergoing clinically-indicated colonoscopy
- •Recurrent c-diff infection (three or more occurrences)
- •Donor inclusion criteria:
- •First-degree relative recommended, but not compulsory
- •≥ 18 years old
- •In good health
- •No antibiotic use within the last 90 days
- •In "low risk" category on modified DHQ (See above)
排除标准
- •Recipient exclusion criteria
- •Severe comorbid condition (at discretion of the principal investigator)
- •On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone)
- •Severe or fulminant C. difficile colitis
- •Toxic appearance
- •Signs of hemodynamic instability
- •Peritoneal signs on physical exam
- •Anemia on complete blood count
- •electrolyte imbalances on basic metabolic panel
- •Considerations for Increased Risk of Adverse Events Should Be Given to patients with decompensated liver cirrhosis, advanced HIV/acquired immune deficiency syndrome, recent bone marrow transplant, or other cause of severe immunodeficiency.
- •History of severe anaphylactic shock
- •Donor exclusion criteria:
- •Abnormal stools
- •Abdominal complaints
- •History of inflammatory bowel disease or gastrointestinal malignancy
- •Symptoms indicative of irritable bowel syndrome or other chronic pain syndromes (e.g. chronic fatigue syndrome, fibromyalgia)
- •History of systemic autoimmunity (e.g. multiple sclerosis, connective tissue disease)
- •Recent use of potent immunosuppressive medications (calcineurin inhibitors, exogenous glucocorticoids, biological agents, etc..)
- •Recent ingestion of a potential allergen (e.g. nuts) where recipient has a known allergy to this (these) agent(s)
- •Known communicable disease
- •Neurologic, neurodevelopmental or neurodegenerative disorders
- •History of malignancy
- •Has consumed any foods/medications to which the recipient is allergic within the designated period of time
结局指标
主要结局
Resolution of C. difficile
时间窗: 6 months post transplant
The primary objective of the study is to establish the cure rate of C. difficile infection in pediatric patients.
次要结局
- Adverse events(Six months post transplant)
研究者
Jonathan Gisser
Faculty
Nationwide Children's Hospital