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

NCT06727253 | Recruiting

• 1 other identifier: GlycanTrigger
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease (CD)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Single Arm, Dietary Supplement: Glycan

EXPERIMENTAL

Dietary Supplement: Glycan

Interventions

Glycan DIETARY_SUPPLEMENT

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

Single Arm, Dietary Supplement: Glycan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• GLSMED Learning Health S.A.: lead

Study Sites (1)

Hospital da Luz Lisboa

Lisbon, Lisbon District, 1500-650, Portugal

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Polysaccharides

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Central Study Contacts

Catarina IM Barbosa, PhD

CONTACT

+351217104544; catarina.moreira.barbosa@luzsaude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 10, 2024
• Study Start: May 26, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)