Clinical trial · Interventional
Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis
Adenoma-Carcinoma Sequence in the Ileal Pouch Anal Anastomosis in Patients With Familial Adenomatous Polyposis: Studies on Luminal and Mucosal Risk Factors and Chemoprevention
NCT00319007CI-TRIAL-00000833unknownPhase 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)
The purpose of this study is to determine whether sulindac and VSL#3 - inulin, either combined or alone, are effective in treating or preventing adenoma development in the ileal anal pouch in patients with familial adenomatous polyposis.
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 |
|---|---|---|---|
| Adenomatous Polyposis Coli | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inulin (probiotic) | Drug | — | UNRESOLVED |
| Sulindac (drug) | Drug | Sulindac | ALIAS |
| VSL#3 (probiotic) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Pouch mucosal proliferation index at 0, 1 and 2 months
- measure
- Pouch mucosal apoptosis index at 0, 1 and 2 months
Secondary outcomes (3)
- measure
- Pouch mucosal Glutathione S transferases activity and isoenzyme levels at 0, 1 and 2 months
- measure
- Faecal genotoxicity at 0, 1 and 2 months
- measure
- Faecal cytotoxicity at 0, 1 and 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically or genetically proven familial adenomatous polyposis * Restorative proctocolectomy with ileal pouch anal anastomosis Exclusion Criteria: * Chronic or acute renal or hepatic disease * History of oesophageal, gastric or duodenal ulcers * Known hypersensitivity to sulindac * Daily use during the last three months of: * Aspirin * Non-Steroidal Anti-Inflammatory Agents * Probiotics
References
Publications (0)
Data not yet available
No reference posted for this study.