Vi-Siblin for LARS: A randomized, controlled trial.
Key facts
- Where
- Grålum, Lorenskog, Skien és Toensberg, NorvégiaSee the 4 sites
- Phase
- 2. fázis
Where in Norvégia
- Østfold Hospital TrustGrålum, NorvégiaToborzás még nem indult
- Akershus University HospitalLorenskog, NorvégiaToborzás még nem indult
- Sykehuset Telemark HFSkien, NorvégiaToborzás még nem indult
- Sykehuset I Vestfold HFToensberg, NorvégiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sykehuset Telemark HF
- Trial code
- EU 2024-514541-11-00
- Record updated
- 2026. október 16.
- Original description
To determine the efficacy of Vi-Siblin on burden of symptoms as measured by LARS scoreRead full original descriptionShow less
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.
To determine the efficacy of Vi-Siblin on burden of symptoms as measured by LARS score
Inclusion: Participant must be 18 ≥ years at the time of signing the informed concent; Participants who report a LARS score >20 at 6 months or more post sphinchter-preserving surgery for rectal cancer (spontanous relieve can occur within the first year); Any temporary stoma must be reversed at least 3 months before inclusion; Capable of giving signed informed concent as described in Appendix 1 in the protocoll; Ability to take oral interventional compound.
Exclusion: Diabetic patients receiving antidiabetic therapy, or patients treated with thyroid hormone-containing medicinal products must be excluded, unless they are under close clinical monitoring, as adjustments to these therapies may be required with concomitant use of the IMP; Prior or ongoing bowel regulatory treatment with similar effect on symptom reduction, including Vi-Siblin. Caution should also be made in case a participant use medicinal products known to inhibit intestinal peristalsis; Various conditions rendering the participant unable to answer questionnaires; Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. in the SmPC (sucrose, sodium chloride); Participants with the following rare, congenital medical conditions, are advised not to use Vi-Siblin and will therefore not be included in the study: inherited fructose intolerance, glucose-galactose malabsorption and sucrase-isomaltase deficiency; Difficulties swallowing or abnormal narrowing (stenosis) of the gastrointestinal tract, especially in the esophagus and cardia; Suspected or known intestinal obstruction; Intestinal paralysis or megacolon.