Oral glycan supplementation to modify the gut lining and reduce Crohn's recurrence after ileal surgery
GlycanTrigger - WP4: Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression: a Pilot Trial
This trial will test whether an oral glycan supplement can change interactions between gut bacteria and the mucosal immune system to prevent Crohn's disease recurrence in adults after ileal or ileocecal resection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | GLSMED Learning Health S.A. Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Lisbon, Lisbon District) |
| Trial ID | NCT06727253 on ClinicalTrials.gov |
What this trial studies
This is a proof-of-concept interventional trial using patients who have undergone ileal or ileocecal resection as a human model of Crohn's disease initiation and progression. Participants will receive an oral glycan supplement and researchers will track changes in the gut glycome, microbiome composition, and mucosal immune responses. The study will use mucosal samples and microbiome profiling alongside clinical follow-up to link molecular changes with early signs of postoperative recurrence. Key exclusions include other forms of colitis, use of postoperative antibiotics or immunomodulators, pregnancy, shellfish/glycan allergy, and serious comorbidities.
Who should consider this trial
Good fit: Adults aged 18–75 with confirmed ileal or ileocolonic Crohn's disease who have undergone ileal or ileocecal resection and are not receiving postoperative antibiotics, aminosalicylates, immunomodulators, biologics, or other prophylactic therapies.
Not a fit: People with ulcerative or other non-Crohn colitis, those taking postoperative antibiotics or immunosuppressants, pregnant or breastfeeding women, individuals with shellfish/glycan allergies, significant uncontrolled diabetes, bleeding disorders, recent cancer, or other conditions that interfere with consent or safety are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the glycan supplement could reduce postoperative mucosal inflammation and lower the risk of Crohn's recurrence by restoring healthy host–microbiome interactions.
How similar studies have performed: Modulating the glycome to alter host–microbiome interactions is a relatively novel approach with supportive preclinical data but limited prior human proof-of-concept results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lisbon, Lisbon District
- Hospital da Luz Lisboa — Lisbon, Lisbon District, Portugal (Recruiting)
Study contacts
- Study coordinator: Catarina IM Barbosa, PhD
- Email: catarina.moreira.barbosa@luzsaude.pt
- Phone: +351217104544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.