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

Recruiting now · Not applicable

Conditions studied: Crohn Disease (CD)

In brief

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.

Key facts

Study ID

NCT06727253

Run by

GLSMED Learning Health S.A.

People needed

30

Starts

2025-05-26

Expected to finish

2028-12-01

Last updated by the study team

2025-08-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital da Luz Lisboa — Lisbon, Lisbon District, Portugal (enrolling)

Full record on ClinicalTrials.gov

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