Crohn Disease (CD)NCT06727253
Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression
A study testing Glycan in people with Crohn Disease (CD), run by GLSMED Learning Health S.A. at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Glycan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 26 May 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Hospital da Luz Lisboa
Lisbon, Lisbon District, 1500-650
Catarina Barbosa, +351 217 104 400, GlycanTrigger@hospitaldaluz.pt
About this study
Official title: GlycanTrigger - WP4: Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression: a Pilot 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.
Read the detailed description
Inclusion Criteria
- Male or female patients between 18 and 75 years old able to provide oral and written informed consent for participation in the study
- Confirmed diagnosis of ileal or ileocolonic CD
- Submitted to ICR or ileal resection for removing the diseased segment of the bowel.
Exclusion Criteria
- Diagnosis of indeterminate colitis, ulcerative colitis or microscopic colitis, including 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, defined as HbA1c greater than 8% or recurrent episodes of hyperglycaemic crisis such as diabetic ketoacidosis or hyperglycaemic hyperosmolar state
- Patients with known bleeding disorders, such as hemophilia or thrombocytopenia, or those receiving anticoagulation therapy, such as 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.
- Conditions
- Crohn Disease (CD)
- Being tested
- Glycan
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycanDietary supplement
The post-operative CD patients will receive an orally administered glycan.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm, Dietary Supplement: Glycan | Experimental | Not described Receives: Dietary Supplement: Glycan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the modulation of the glycome on the microbial changes that contribute to disease development
Measured: From enrolment until 6 months following surgery
The effect of the modulation of the glycome on the immunological changes that contribute to disease development
Measured: From enrolment until 6 months following surgery
Secondary outcomes (5)
The immunomodulatory effect of glycans on endoscopic recurrence
Measured: From enrolment until 6 months following surgery
The immunomodulatory effect of glycans on clinical recurrence
Measured: From enrolment until 6 months following surgery
The immunomodulatory effect of glycans on histological recurrence
Measured: From enrolment until 6 months following surgery
The immunomodulatory effect of glycans on systemic inflammatory biomarkers pre-surgery
Measured: From enrolment until 6 months following surgery
The immunomodulatory effect of glycans on systemic inflammatory biomarkers post-surgery
Measured: From enrolment until 6 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start26 May 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GLSMED Learning Health S.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727253
- Sponsor's protocol ID
- GlycanTrigger
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlycanTrigger - WP4: Glycan Supplementation on a Human Model of Crohn's Disease Initiation and Progression: a Pilot Trial
- ClinicalTrials.gov ID
- NCT06727253
- Acronym / sponsor ID
- GlycanTrigger
- Conditions
- Crohn Disease (CD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GLSMED Learning Health S.A.University, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inclusion Criteria
- Male or female patients between 18 and 75 years old able to provide oral and written informed consent for participation in the study
- Confirmed diagnosis of ileal or ileocolonic CD
- Submitted to ICR or ileal resection for removing the diseased segment of the bowel.
Exclusion Criteria
- Diagnosis of indeterminate colitis, ulcerative colitis or microscopic colitis, including 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, defined as HbA1c greater than 8% or recurrent episodes of hyperglycaemic crisis such as diabetic ketoacidosis or hyperglycaemic hyperosmolar state
- Patients with known bleeding disorders, such as hemophilia or thrombocytopenia, or those receiving anticoagulation therapy, such as 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm, Dietary Supplement: Glycan | Experimental | Dietary Supplement: Glycan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycanThe post-operative CD patients will receive an orally administered glycan. | Dietary supplement | Single Arm, Dietary Supplement: Glycan |
Primary outcome
The effect of the modulation of the glycome on the microbial changes that contribute to disease development
Time frame: From enrolment until 6 months following surgery
The effect of the modulation of the glycome on the immunological changes that contribute to disease development
Time frame: From enrolment until 6 months following surgery
5 secondary outcomes
The immunomodulatory effect of glycans on endoscopic recurrence
Time frame: From enrolment until 6 months following surgery
The immunomodulatory effect of glycans on clinical recurrence
Time frame: From enrolment until 6 months following surgery
The immunomodulatory effect of glycans on histological recurrence
Time frame: From enrolment until 6 months following surgery
The immunomodulatory effect of glycans on systemic inflammatory biomarkers pre-surgery
Time frame: From enrolment until 6 months following surgery
The immunomodulatory effect of glycans on systemic inflammatory biomarkers post-surgery
Time frame: From enrolment until 6 months following surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycan in people with Crohn Disease (CD), run by GLSMED Learning Health S.A. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catarina IM Barbosa, PhD (+351217104544, catarina.moreira.barbosa@luzsaude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of the modulation of the glycome on the microbial changes that contribute to disease development (time frame: From enrolment until 6 months following surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.