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Clinical Trials in Portugal / NCT06727253
Recruiting Not applicable

Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression

NCT06727253 · tracked via the Priya Life Science Portugal tracker
Phase
Not applicable
Started
2025-05-26
Last updated
2025-08-05

Condition(s) studied

Crohn Disease (CD)

Investigational drug(s) / intervention(s)

Glycan

Glycan: The post-operative CD patients will receive an orally administered glycan.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital da Luz Lisboa Lisbon Lisbon District Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06727253 on ClinicalTrials.gov ↗ ← All trials in Portugal