Gut microbiome after colorectal intestinal anastomosis
Official title: Analysis of the Composition of the Intestinal Microbiota and Its Evolution in Patients Post-intestinal Anastomosis
Run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · NCT07416760 · Data updated 2026-11-12
This study will see if differences in the gut microbiome are linked to anastomotic leakage in adults undergoing colorectal intestinal anastomosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Academic / other |
| Locations | 1 site (Madrid) |
| Status | Recruiting |
| Started | February 14, 2026 |
| Main results expected | February 14, 2026 |
| Study ends | December 14, 2026 |
| Registry record updated | February 18, 2026 |
| Trial ID | NCT07416760 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) in good functional status scheduled for elective colorectal intestinal anastomosis who can give informed consent and attend postoperative follow-up are ideal candidates.
✕Probably not a fit
Patients having emergency surgery, with intra-abdominal sepsis or prior dehiscence, severe immunosuppression, recent antibiotic use within 3 months, or who are pregnant or breastfeeding are unlikely to benefit from this observational analysis.
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 prospective, descriptive, non-interventional study enrolling adults who undergo colorectal intestinal anastomosis at a single hospital. Stool samples will be collected before surgical preparation, during the operation, and in the postoperative period to profile bacterial composition and diversity. Microbiome sequencing and bioinformatic analyses will compare patients who develop anastomotic dehiscence with those who do not. The study aims to correlate microbial patterns, including Lachnospiraceae abundance and overall diversity, with anastomotic outcomes.
Why it matters
Potential benefit: If successful, the study could identify microbiome markers that predict higher risk of anastomotic leakage and help guide prevention or monitoring strategies.
How similar studies have gone: Previous observational studies have reported links between lower microbial diversity, higher Lachnospiraceae abundance, and anastomotic leakage, but findings are correlational and causality remains unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have undergone colorectal intestinal anastomosis. * Signing of the informed consent form. * Age ≥18 years with good functional status. * Availability for postoperative follow-up. Exclusion Criteria: * Emergency surgery. * Intra-abdominal sepsis or previous dehiscence. * Severe immunosuppression. * Use of antibiotics in the 3 months prior to preoperative preparation. * Pregnancy or breastfeeding.
Where it's running
-
University Hospital Fundación Jiménez Díaz
Madrid, Spain Recruiting
Study contacts
- Principal investigator: Mariano García-Arranz, PhD — Health Research Institute Fundación Jiménez Díaz
- Study coordinator: Héctor Guadalajara-Labajo, MD, PhD
- Email: h.guadalajara@quironsalud.es
- Phone: + 34 550 4800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.