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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD)
• Intervention / Treatment: Dietary supplement: Glycan

Detailed Description

Inclusion Criteria

• Male or female patients between 18 and 75 years old able to provide oral and written informed consent for participation in the study
• Confirmed diagnosis of ileal or ileocolonic CD
• Submitted to ICR or ileal resection for removing the diseased segment of the bowel.

Exclusion Criteria

• Diagnosis of indeterminate colitis, ulcerative colitis or microscopic colitis, including 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, defined as HbA1c greater than 8% or recurrent episodes of hyperglycaemic crisis such as diabetic ketoacidosis or hyperglycaemic hyperosmolar state
• Patients with known bleeding disorders, such as hemophilia or thrombocytopenia, or those receiving anticoagulation therapy, such as 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catarina IM Barbosa, PhD; Phone Number: +351217104544; Email: catarina.moreira.barbosa@luzsaude.pt

Study Locations

• Portugal
  • Lisboa, Portugal, 1500-650
    • Recruiting
    • Hospital da Luz Lisboa
    • Contact: Catarina Barbosa; Phone Number: +351 217 104 400; Email: GlycanTrigger@hospitaldaluz.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm, Dietary Supplement: Glycan	Dietary supplement: Glycan; The post-operative CD patients will receive an orally administered glycan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: GLSMED Learning Health S.A.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: GlycanTrigger

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No