NCT06727253 Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression
| NCT ID | NCT06727253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GLSMED Learning Health S.A. |
| Condition | Crohn Disease (CD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-05-26 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06727253 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Crohn Disease (CD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06727253 currently recruiting?
Yes, NCT06727253 is actively recruiting participants. Contact the research team at catarina.moreira.barbosa@luzsaude.pt for enrollment information.
Where is the NCT06727253 trial being conducted?
This trial is being conducted at Lisbon, Portugal.
Who is sponsoring the NCT06727253 clinical trial?
NCT06727253 is sponsored by GLSMED Learning Health S.A.. The trial plans to enroll 30 participants.