GlycanTrigger - WP4: Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression: a Pilot Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Portugal
Hospital da Luz Lisboa
RECRUITING
Lisbon
Contact Information
Primary
Catarina IM Barbosa, PhD
catarina.moreira.barbosa@luzsaude.pt
+351217104544
Time Frame
Start Date: 2025-05-26
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 30
Treatments
Experimental: Single Arm, Dietary Supplement: Glycan
Related Therapeutic Areas
Sponsors
Leads: GLSMED Learning Health S.A.

This content was sourced from clinicaltrials.gov

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