Crohn'sRecruiting
Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression
Not applicable · Testing Glycan · 1 site · GLSMED Learning Health S.A.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Glycan (a dietary supplement) to better understand how the disease works. Condition(s) listed: Crohn Disease (CD).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-05-26.
- Main results expected around 2028-06-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Portugal.
Groups in this study
- Single Arm, Dietary Supplement: Glycan (listed as: experimental group)
Main thing being measured
- 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)
In the researchers’ words
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…
Words you might see
- Biologic: a medicine made from living cells, usually given by injection or infusion.
- Biopsy / histology: a small tissue sample examined under a microscope.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | GLSMED Learning Health S.A. |
| Enrollment | 30 (estimated) |
| Start date | 2025-05-26 |
| Primary completion (est.) | 2028-06-01 |
| First posted | 2024-12-10 |
| Last updated | 2026-10-15 |
| Official title | GlycanTrigger - WP4: Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression: a Pilot Trial |
| ClinicalTrials.gov ID | NCT06727253 |
Interventions
- Glycan (Dietary Supplement)
The post-operative CD patients will receive an orally administered glycan.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital da Luz Lisboa | Lisbon, Lisbon District | Portugal | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.