Clinical trial · Observational
Microbiota Implementation to Reduce Anastomotic Colorectal Leaks (MIRACLe)
Can we Manipulate the Bowel Microbiota and Prevent Anastomotic Leakage in Colorectal Laparoscopic Surgery? Preliminary Results of the MIRACLe Study.
NCT05164887CI-TRIAL-00065767MIRACLecompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aim of this study is to implement the intestinal microbiota by perioperative administration of probiotics, oral antibiotics and low volume mechanical preparation in order to reduce the incidence of colorectal anastomotic leaks and dehiscences.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| LAP | — | UNRESOLVED | — |
| Microbial Substitution | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic colorectal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- MIRACLe patients
- description
- Patient affected by colorectal cancer submitted to laparoscopic resection with MBP + OA + perioperative Probiotics administration. MBP = oral polyphosphate 500ml preoperative OA = Amoxicillin/Clavulanic acid 1g x 2 + metronidazole 250mg x 3 Probiotics = Streptococcus thermophilus; Bifidobacterium breve; Bifidobacterium longum; Bifidobacterium infantis; Lactobacillus acidophilus; Lactobacillus plantarum; Lactobacillus paracasei; Lactobacillus delbrueckii subsp. Bulgaricus 4,4g x 2
- interventionNames
- Procedure: Laparoscopic colorectal resection
Primary outcomes (1)
- measure
- Incidence of Fistulas and Anastomotic Leaks
- timeFrame
- 4 weeks
- description
- Evaluation of incidence of AL compared to a group of 500 colorectal resection in patient prepared with ev antibiotics, no MBP and without probiotics administration
Secondary outcomes (1)
- measure
- Incidence of SSI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * ASA I - II - III * Colorectal cancer * Elective surgery * Laparoscopic resections Exclusion Criteria: * Age \< 18 years * ASA IV * Emergency surgery * Laparotomic resections * Diverticular disease or IBD * Hartmann or Miles procedures * Stomies * Major intraoperative complications
References
Publications (0)
Data not yet available
No reference posted for this study.