EUCTR2020-000311-71-FR进行中（未招募）1 期
Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset
AP-HP/DRCD0 个研究点目标入组 80 人开始时间: 2021年9月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •Criteria for inclusion of the patient recipient of the TMF:
- •- Patient aged 8 to 17;
- •- With UC, regardless of the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria;
- •- Flare-up UC defined by a PUCAI score> 35 and responding to treatment with corticosteroids at 40 mg / day maximum with, on inclusion, a PUCAI score <10;
- •- Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months;
- •- Patient capable of ingesting the test capsules;
- •- For girls of childbearing age:
- •- have a negative blood (or urine) pregnancy test;
- •- agree to use a reliable contraceptive method from visit 1 until the end of the research;
- •- Being a beneficiary of a social protection scheme or having rights (excluding AME);
- •- Have an informed consent form signed by both parents or by the person (s) with parental authority.
- •Inclusion criteria of the healthy voluntary subject donor of stool:
- •- Age between 18 and 50 years old (so that the donor's microbiota is in a period of stability of its flora);
- •- 17 kg / m² - Have a usually regular transit consisting of at least one stool every two days and a maximum of 2 stools per day;
- •- For women of childbearing age: have a negative pregnancy blood test;
- •- Being a beneficiary of a social protection scheme or having rights (excluding AME);
- •- Have a signed free and informed consent form.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Criteria for non-inclusion of the TMF Receiver:
- •- Have isolated proctitis (<5 cm)
- •- Have severe colitis defined by a PUCAI score> 65
- •- Be under enteral nutrition
- •- Have received an antibiotic or antifungal treatment in the 4 weeks preceding inclusion
- •- Have a Clostridioides difficile infection in the 4 weeks prior to inclusion
- •- be pregnant or breastfeeding, or have a positive pregnancy test
- •- Have a contraindication to colonoscopy or general anesthesia
- •- Participation in another intervention research involving the human person.
- •Criteria for non-inclusion of the healthy voluntary subject donor of stool (final and temporary) +
- •According to ANSM criteria
研究者
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