Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression
ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGLSMED Learning Health S.A.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Glycan
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov