Oral glycan supplementation to modify the gut lining and reduce Crohn's recurrence after ileal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.