Clinical trial · Interventional
Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome
A Randomized, Phase 2 Study of Anal Dilatation Plus Probiotics Before Ileostomy Reduction for Low Anterior Resection Syndrome After Sphincter-preserving Proctectomy
NCT04688242CI-TRIAL-00062509PILLARSunknownPhase 2ClinicalTrials.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)
This is randomized, phase 2 trial in patients with rectal cancer undergoing sphincter-preserving proctectomy and temporary ileostomy, to explore the effects of anal dilatation plus probiotics administered per anus before ileostomy reduction in relieving postoperative bowel dysfunction known as low anterior resection syndrome (LARS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus | Drug | — | UNRESOLVED |
| Anal dilatation per anus | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- Anal dilatation plus probiotics per anus Q3D, starting from 2 weeks after proctectomy until reduction of ileostomy.
- interventionNames
- Other: Anal dilatation per anus
- Drug: administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- No anal dilatation or probiotics per anus was allowed, from 2 weeks after proctectomy until reduction of ileostomy.
Primary outcomes (1)
- measure
- Major LARS at 1 years after proctectomy
- timeFrame
- At 1 years after proctectomy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. A voluntarily signed and dated informed consent form; 2. ECOG Performance status is 0 or 1; 3. Age at enrollment is of 18 to 80 years old.; 4. R0 sphincter-preserving proctectomy and temporary ileostomy for rectal cancer; 5. The distance from anastomosis to anal verge is ≤7cm; 6. Both the anastomosis and the ileostomy is intact at 2 weeks follow-up after proctectomy; 7. Baseline LARS score before proctectomy is \<30; 8. The preoperatively predicted LARS (POLARS) score after proctectomy is ≥28. Exclusion Criteria: 1. R1/R2 resection or untreated metastases; 2. Any synchronous or metachronous malignancies, except for cancers that have received curative treatment and have not recurred for more than 5 years, or carcinoma in situ that have been cured by appropriate treatment; 3. Severe morbidity with life expectancy less than 2 years; 4. Any toxicity of CTCAE grade 2 or above due to previous treatment that have not resolved, except for anemia, alopecia, skin pigmentation; 5. Anastomotic leak within 2 weeks after proctectomy, suspected by clinical symptoms, digital rectal examination, or imaging; 6. Complications of the ileostomy within 2 weeks after proctectomy, leading to premature takedown of the stoma (within 2 months after surgery); 7. Any medical condition that may affect the safety and compliance of the subject.
References
Publications (0)
Data not yet available
No reference posted for this study.