CTRI/2024/01/062063招募中2/3 期
Efficacy and Safety Of Oral Lyophilized Fecal Microbiome Capsules For Induction And Maintenance Of Remission In Moderately Severe Ulcerative Colitis
Vardhman Textiles Limited1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月1日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical remission (defined as total Mayo score ≤2, with no individual sub-score exceeding 1 point)
研究概览
简要总结
Ulcerative colitis (UC) is a chronic, disabling immune mediated inflammatory condition affecting the large bowel, which is thought to be caused by an aberrant interaction between the immune system and a dysbiotic intestinal microbiome. There is emerging evidence that faecal microbiota transplantation (FMT) is effective in treating UC. This is a double blind, randomised, placebo-controlled trial of orally administered lyophilized FMT capsules in patients with chronic active UC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of UC with active disease, defined as a total Mayo score of 6–9, and a Mayo endoscopic subscore of 1 or more.
- •Any disease extent : E1, E2 or E3
- •Diagnosis (endoscopic or radiographic and histological) of UC at least 6 months prior to enrolment into the study
- •Subjects who are willing and able to comply with treatment plan, laboratory tests.
- •Subjects who are willing to provide a written informed consent.
排除标准
- •Subjects without previous treatment for IBD (i.e. treatment-naïve).
- •Active or latent or inadequately treated infections(includingClostridiodes difficile, Cytomegalovirus, Mycobacterium tuberculosis, etc.)
- •Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
- •Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
- •Subjects with current malignancies or a past history of malignancies.
- •Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease.
- •Pregnant females.
结局指标
主要结局
Clinical remission (defined as total Mayo score ≤2, with no individual sub-score exceeding 1 point)
时间窗: Week 8, Week 48
次要结局
- Clinical response (defined as decrease in total Mayo score by at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub-score of at least 1 point or absolute rectal bleeding sub-score of 0 or 1)(Week 8, Week 48)
- Endoscopic remission (defined as endoscopic Mayo sub-score of 0)(Week 8, Week 48)
研究者
Ajit Sood
Dayanand Medical College and Hospital, Ludhiana
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Pentoxifylline in Patients With Ulcerative ColitisNCT07349472Ihab Elsayed Hassan60
招募中
3 期
A study to evaluate the effect of fecal transplant and dietary changes on disease activity in patients with newly diagnosed active ulcerative colitis.CTRI/2025/01/079676Indian Council of Medical Research220
尚未招募
3 期
A study to evaluate the effect of fecal transplant and dietary changes on disease activity in patients with ulcerative colitis on advanced therapiesCTRI/2025/02/080272Indian Council of Medical Research220
尚未招募
Phase 3 4
A clinical study to compare how effective Piccha Basti (a special Ayurvedic enema) and Sheetala Dhara (a cooling therapy) are in helping people with ulcerative colitis (a type of long-term inflammation in the large intestine)CTRI/2025/10/096639Dr Nainika J Chouta30
尚未招募
2 期
Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing CholangitisNCT07341282McMaster University14