GlycanTrigger - WP4: Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression: a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The effect of the modulation of the glycome on the microbial changes that contribute to disease development
研究概览
简要总结
The overall aim of this proof-of-concept trial is to investigate the effect of an orally administered glycan on the modulation of the dysregulation of host-microbiome interactions and its effect on the mucosal immune response. Post-operative Crohn's Disease patients will be used as a representative model to mimic the immunopathogenic pathway of health-to-disease transition. Changes in gut glycocalyx seem to be a primary event involved in the disruption of the interaction between the microbiota and the host immune system. Thus, this study aims to assess the effect of the modulation of the glycome on the microbial and immunological changes that contribute to disease development.
详细描述
Inclusion Criteria
- Male or female patients between 18 and 75 years old able to provide oral and written informed consent for participation in the study
- Confirmed diagnosis of ileal or ileocolonic CD
- Submitted to ICR or ileal resection for removing the diseased segment of the bowel.
Exclusion Criteria
- Diagnosis of indeterminate colitis, ulcerative colitis or microscopic colitis, including collagenous colitis or lymphocytic colitis
- Patients receiving antibiotics, aminosalicylates, thiopurines, methotrexate, biologics or small molecules after surgery for postoperative recurrence
- Patients with previous ICR or ileal resection due to CD, unless the treating physician does not intend to start other prophylactic therapy apart from the glycan supplement within the first 6 months following surgery
- Pregnant or lactating women
- Documented allergy to shellfish, glycans or glycans derivatives
- History of dysplasia on colonic biopsy
- Presence of, or history of cancer, except for skin cancer
- History of poorly controlled type 1 or type 2 diabetes, defined as HbA1c greater than 8% or recurrent episodes of hyperglycaemic crisis such as diabetic ketoacidosis or hyperglycaemic hyperosmolar state
- Patients with known bleeding disorders, such as hemophilia or thrombocytopenia, or those receiving anticoagulation therapy, such as warfarin or direct oral anticoagulants
- Any physical or mental condition which would interfere with the ability to provide written and oral free informed consent or limit the study participation, collection of data, or study completion as determined by the Investigator
- Unwillingness or inability to follow the procedures outlined in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 and 75 years old (inclusive) able to provide oral and written informed consent for participation in the study
- •Confirmed diagnosis of ileal or ileocolonic CD (according to ECCO guidelines)
- •Patients submitted to ileal and ileocecal resection for removing the diseased segment of the bowel.
排除标准
- •Diagnosis of indeterminate colitis, ulcerative colitis or microscopic colitis (collagenous colitis or lymphocytic colitis)
- •Patients receiving antibiotics, aminosalicylates, thiopurines, methotrexate, biologics or small molecules after surgery for postoperative recurrence
- •Patients with previous ICR or ileal resection due to CD, unless the treating physician does not intend to start other prophylactic therapy apart from the glycan supplement within the first 6 months following surgery
- •Pregnant or lactating women
- •Documented allergy to shellfish, glycans or glycans derivatives
- •History of dysplasia on colonic biopsy
- •Presence of, or history of cancer, except for skin cancer
- •History of poorly controlled type 1 or type 2 diabetes (HbA1c>8% or recurrent episodes of hyperglycaemic crisis such as diabetic ketoacidosis or hyperglycaemic hyperosmolar state)
- •Patients with known bleeding disorders (e.g. haemophilia or thrombocytopenia) or anticoagulation therapy (e.g. warfarin or direct oral anticoagulants)
- •Any physical or mental condition which would interfere with the ability to provide written and oral free informed consent or limit the study participation, collection of data, or study completion as determined by the Investigator
- •Unwillingness or inability to follow the procedures outlined in the protocol.
结局指标
主要结局
The effect of the modulation of the glycome on the microbial changes that contribute to disease development
时间窗: From enrolment until 6 months following surgery
The effect of the modulation of the glycome on the immunological changes that contribute to disease development
时间窗: From enrolment until 6 months following surgery
次要结局
- The immunomodulatory effect of glycans on endoscopic recurrence(From enrolment until 6 months following surgery)
- The immunomodulatory effect of glycans on clinical recurrence(From enrolment until 6 months following surgery)
- The immunomodulatory effect of glycans on histological recurrence(From enrolment until 6 months following surgery)
- The immunomodulatory effect of glycans on systemic inflammatory biomarkers pre-surgery(From enrolment until 6 months following surgery)
- The immunomodulatory effect of glycans on systemic inflammatory biomarkers post-surgery(From enrolment until 6 months following surgery)
