NCT06727253Recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Nov 2024
- Start date
- 26 May 2025
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- GLSMED Learning Health S.A.
- Diseases
- Crohn's disease
- NCT number
- NCT06727253
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 26 May 2025 to the primary completion date, 1 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Documented allergy to shellfish, glycans or glycans derivatives
- History of dysplasia on colonic biopsy
- Presence of, or history of cancer, except for skin cancer
- 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
Lab values
- 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)
Other
- Diagnosis of indeterminate colitis, ulcerative colitis or microscopic colitis (collagenous colitis or lymphocytic colitis)
- Pregnant or lactating women
- Unwillingness or inability to follow the procedures outlined in the protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital da Luz Lisboa Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.