A randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and quality of life outcomes of Vi-Siblin in patients with low anterior resection syndrome following rectal cancer surgery.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514541-11-00

Enrollment

120

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low anterior resection syndrome after low anterior resection for rectal cancer

Brief summary

Total LARS score 8 weeks after start of treatment

Detailed description

HRQoL scores 8 weeks after start of treatment, Time (in weeks) from initiation of treatment to first clinically relevant improvement in LARS score, LARS scores and its items at baseline and after 8 weeks of treatment

Interventions

DRUGPlacebo powder will be produced according to tabel 1.2 in the IMPD-Q

DRUGVi-Siblin granulat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Total LARS score 8 weeks after start of treatment	—

Secondary

Measure	Time frame
HRQoL scores 8 weeks after start of treatment, Time (in weeks) from initiation of treatment to first clinically relevant improvement in LARS score, LARS scores and its items at baseline and after 8 weeks of treatment	—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 28, 2026