EUCTR2014-005666-29-GB进行中（未招募）1 期
A Phase 1 randomised, double-blind, placebo-controlled study to assess the safety and tolerability of Bacteroides thetaiotaomicron in young people aged 16 to 18 years with stable Crohn's disease. - A study of Thetanix in young people with stable Crohn's disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 4D Pharma
- 入组人数
- 18
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
入选标准
- •1. Subjects aged 16 to 18 years with confirmed diagnosis of Crohn's disease who are currently in clinical remission in the opinion of the Investigator, and who are otherwise healthy.
- •2. Subjects who are able and willing to give written informed consent to participate.
- •Remission is defined as:
- •Physician's global assessment that subject is in remission; Weighted Paediatric Crohn's Disease Activity Index (wPCDAI) less than or equal to 12.5; no clinically significant, in the opinion of the Investigator, elevations of platelets, white cell count, C-reactive protein or ESR and no clinically significant decrease in albumin or haemoglobin.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Subjects who are pregnant or breastfeeding
- •2. Subjects who are experiencing an exacerbation at the time of screening or up to the time of the first dose.
- •3. Subjects who have undergone surgery for resection of bowel in the last 12 months or subjects who have undergone resection of bowel more than 12 months ago, and have experienced an exacerbation in the last 12 months or developed fistulae. (Subjects who have had resection of bowel more than 12 months ago, with no further requirement for surgery within the last 12 months, with stable medications as per other inclusion/exclusion criteria; and subjects who have surgery for perianal abscess more than 6 months prior to dosing remain eligible.)
- •4. Subjects who have fistulisation.
- •5. Subjects who have a significant change in their immune-modulating maintenance in the 3 months prior to screening and/or the start of dosing.
- •6. Subjects who have taken systemic steroids in the last 3 months (rectal and inhaled steroid use is permitted.)
- •7. Subjects who are unable to take any oral feeding.
- •8. Subjects with feeding gastrostomies.
- •9. Subjects who have non-food dietary supplementation for any reason changed within 1 month prior to dosing.
- •10. Subjects who are receiving a dose of monoclonal antibodies that has required adjustment, due to clinical indications relating to their underlying CD, and therefore has not been within a stable dosing range (e.g. 5mg/kg 8 weekly, allowing for changes in patient weight) for the past 12 months, or who have evidence of an exacerbation. (Note: subjects who have missed doses of monoclonal antibodies due to intercurrent illness unavailability, exams, holidays, other extraneous or non-clinical reasons are eligible).
- •11. Subjects who have received antibiotics or probiotic dietary supplementation in the two weeks before dosing. Subjects who have received foods with probiotics e.g. yoghurts will be permitted to volunteer for the study.
- •12. Subjects who are receiving exclusive enteral feeding or have completed a course of exclusive enteral feeding in the 3 months prior to dosing.
- •13. Subjects with concomitant autoimmune diseases (e.g. Type 1 diabetes, juvenile arthritis, psoriasis).
- •14. Female subjects of child bearing potential unwilling to use effective contraception. An effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, IUDs (Intrauterine device), condoms, occlusive caps (cervical/vault caps) with spermicidal foam/gel/film/cream/pessary. True sexual abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial and withdrawal are not acceptable methods of contraception).
- •15. Subjects with clinically significant, in the opinion of the Investigator, elevated platelets, white cell count, C-reactive protein, ESR, low albumin or haemoglobin.
- •16. Subjects who are positive for the following viruses: HIV, hepatitis B and hepatitis C.
- •17. Subjects who
研究者
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