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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm, Dietary Supplement: Glycan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycan | Dietary Supplement | The post-operative CD patients will receive an orally administered glycan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect of the modulation of the glycome on the microbial changes that contribute to disease development | From enrolment until 6 months following surgery | |
| The effect of the modulation of the glycome on the immunological changes that contribute to disease development | From enrolment until 6 months following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catarina IM Barbosa, PhD | Contact | +351217104544 | catarina.moreira.barbosa@luzsaude.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da Luz Lisboa | Recruiting | Lisbon | Lisbon District | 1500-650 | Portugal |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| 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 |
| D007410 | Intestinal Diseases |