Crohn DiseaseNCT06146335
Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery
A study testing Kono-S anastomosis (KSa) and Side-to-side anastomosis (SSa) in people with Crohn Disease, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Kono-S anastomosis (KSa) and Side-to-side anastomosis (SSa)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Crohn's ileitis/ileocolitis requiring surgical resection OR patients previously enrolled in the "Kono-S anastomosis versus side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn's Disease (WC IRB #1303013645)" trial.
- Patients age 18 years and older.
- All phenotypes will be included: nonstricturing nonpenetrating (B1), stricturing (B2), and penetrating (B3) according to the Vienna classification.
- Patients will be included regardless of preoperative medications (untreated, steroids, biologics)
Who cannot join
- Patients under 18 years of age.
- Pregnant patients.
- Patient does not speak English
- Patients that may need a different surgical procedure as per the surgeon at the time of intraoperative evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical Center
New York, New York, 10065
About this study
The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.
Read the detailed description
These are two are different ways to re-connect the intestines after a portion of it is removed during surgery. Patients will be randomly assigned to either be re-connected with a procedure called the Kono-S anastomosis or with a side-to-side anastomosis during their surgery. This study will look at the microbiome and immune environment in the piece of intestine that is removed during surgery. Then, at the follow colonoscopies (3-6 month, 12-18 month, 60 month), biopsies (small pieces of tissue) will be taken near the connection between the small intestine and colon. This will be used to see how the microbiome and immune system in that area changed since the surgery. Genetic tests will be used to measure the microbiome and the levels of immune proteins in the intestines.
- Conditions
- Crohn Disease
- Being tested
- Kono-S anastomosis (KSa), Side-to-side anastomosis (SSa)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kono-S anastomosis (KSa)Procedure or surgery
antimesenteric functional end-to-end handsewn anastomosis connecting small intestine and colon after surgery
Side-to-side anastomosis (SSa)Procedure or surgery
side-to-side anastomosis connecting small intestine and colon after surgery
| Study group | Role | What they receive |
|---|---|---|
| Kono-S anastomosis (KSa) | Experimental | Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis Receives: Procedure: Kono-S anastomosis (KSa) |
| side-to-side anastomosis (SSa) | Active comparator | Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis Receives: Procedure: Side-to-side anastomosis (SSa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in composition of the microbiome between treatment groups
Microbiome composition will be measured via an analysis of of 16S rRNA sequencing from tissue samples.
Measured: At the time of the surgery
Changes in the immune cell environment between treatment groups
Immune cell environment in the tissue will be measured by gene expression levels in the tissue sample via bulk RNA sequencing.
Measured: 3-6 month, 12-18 month and 60 month post-surgery endoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start3 Jan 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's & Colitis Foundation of America, Inc.
- Responsible party
- Sponsor
- Investigators
- Fabrizio Michelassi, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146335
- Sponsor's protocol ID
- 23-07026235
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2023
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06146335
- Acronym / sponsor ID
- 23-07026235
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Crohn's & Colitis Foundation of America, Inc.
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 Nov 2023 (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 purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.
Detailed description
These are two are different ways to re-connect the intestines after a portion of it is removed during surgery. Patients will be randomly assigned to either be re-connected with a procedure called the Kono-S anastomosis or with a side-to-side anastomosis during their surgery. This study will look at the microbiome and immune environment in the piece of intestine that is removed during surgery. Then, at the follow colonoscopies (3-6 month, 12-18 month, 60 month), biopsies (small pieces of tissue) will be taken near the connection between the small intestine and colon. This will be used to see how the microbiome and immune system in that area changed since the surgery. Genetic tests will be used to measure the microbiome and the levels of immune proteins in the intestines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kono-S anastomosis (KSa) | Experimental | Procedure: Kono-S anastomosis (KSa)Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis |
| side-to-side anastomosis (SSa) | Active comparator | Procedure: Side-to-side anastomosis (SSa)Randomized enrollment of preoperative patients undergoing surgical resection for Crohn's ileitis or ileocolitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Crohn's ileitis/ileocolitis requiring surgical resection OR patients previously enrolled in the "Kono-S anastomosis versus side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn's Disease (WC IRB #1303013645)" trial.
- Patients age 18 years and older.
- All phenotypes will be included: nonstricturing nonpenetrating (B1), stricturing (B2), and penetrating (B3) according to the Vienna classification.
- Patients will be included regardless of preoperative medications (untreated, steroids, biologics)
Key exclusion criteria (4 listed)
- Patients under 18 years of age.
- Pregnant patients.
- Patient does not speak English
- Patients that may need a different surgical procedure as per the surgeon at the time of intraoperative evaluation
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 |
|---|---|---|
| Kono-S anastomosis (KSa)antimesenteric functional end-to-end handsewn anastomosis connecting small intestine and colon after surgery | Procedure or surgery | Kono-S anastomosis (KSa) |
| Side-to-side anastomosis (SSa)side-to-side anastomosis connecting small intestine and colon after surgery | Procedure or surgery | side-to-side anastomosis (SSa) |
Primary outcome
Changes in composition of the microbiome between treatment groups
Time frame: At the time of the surgery
Microbiome composition will be measured via an analysis of of 16S rRNA sequencing from tissue samples.
Changes in the immune cell environment between treatment groups
Time frame: 3-6 month, 12-18 month and 60 month post-surgery endoscopy.
Immune cell environment in the tissue will be measured by gene expression levels in the tissue sample via bulk RNA sequencing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- 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. This study is not recruiting at the moment.
Fabrizio Michelassi, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kono-S anastomosis (KSa) and Side-to-side anastomosis (SSa) in people with Crohn Disease, run by Weill Medical College of Cornell University at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in composition of the microbiome between treatment groups (time frame: At the time of the 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 18 Nov 2025.