Clinical trial · Interventional
Autologous Probiotics in Patients With Defunctioning Ileostomy Following LAR for Rectal Cancer
The Safety and Efficacy of Autologous Probiotics in Patients With Defunctioning Ileostomy Following Low Anterior Resection for Rectal Cancer.
- 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)
Rectal cancer patients who received low anterior resection combined with ileostomy may effectively reduce the probability of anastomotic leakage after surgery. However, due to the long-term semi-abandoned state of the distal colon, the probability of bowel dysfunction after ileostomy closure is very high. The incidence of low anterior resection syndrome (LARS) exceeds 70%, which is twice that of those who did not receive a preventive stoma. The main reasons include postoperative anatomical structure alteration, nerve damage, pathological changes of the colorectal mucosa, and gut microbiota variation, etc. The application of probiotics can significantly improve the bowel function of these patients. In this study, in order to enhance the colonization effect of probiotics, autologous probiotics will be applied to treat patients with defunctioning ileostomy. The primary outcome is the occurrence of major LARS after 6 months of the treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Probiotic Transplantation | — | UNRESOLVED | — |
| Defunctioning Ileostomy | — | UNRESOLVED | — |
| Gut Microbiomes | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Probiotics | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Probiotics Transplantation
- description
- Patients with defunctioning ileostomy following low anterior resection for rectal cancer, receive autologous probiotic (lactobacillus and bifidobacterium) after ileostomy closure.
- interventionNames
- Dietary Supplement: Autologous Probiotics
Primary outcomes (1)
- measure
- Number of participants with major low anterior resection syndrome score (LARS score)
- timeFrame
- at the time of 6 months since the start of treatment
Secondary outcomes (4)
- measure
- Quality of life impairment assessed by Short Form 36 (SF-36)
- timeFrame
- at the time of 1, 3, 6, 12 months since the start of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Age: 18-80years old; Curative low anterior resection for rectal cancer with defunctioning ileostomy; ileostomy closure within 3-6 month; Preoperative chemoradiotherapy ; No evidence of anastomotic leakage or severe stenosis Exclusion Criteria: Tumor recurrence or distant metastasis; Secondary operation with stoma; Prior disease impairing bowel function except for rectal cancer; Any contraindication for transanal irrigation; Pregnant or nursing; Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; Cognitive or psychological disorder;
References
Publications (0)
Data not yet available