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Vi-Siblin for LARS: A randomized, controlled trial.
EU CTIS ID: 2024-514541-11-00
What this study is testing
To determine the efficacy of Vi-Siblin on burden of symptoms as measured by LARS score
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be 18 ≥ years at the time of signing the informed concent
- Participants who report a LARS score >20 at 12 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
You likely can't join if
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. in the SmPC (sucrose, sodium chloride).
- 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.
- 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.
- 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.
See the full eligibility criteria
- Participant must be 18 ≥ years at the time of signing the informed concent
- Participants who report a LARS score >20 at 12 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
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. in the SmPC (sucrose, sodium chloride).
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.