Vi-Siblin for LARS: A randomized, controlled trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sykehuset Telemark HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-04-27

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

South-Eastern Norway Regional Health Authority · Kragerø Tablettfabrikk AS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

To determine the efficacy of Vi-Siblin on burden of symptoms as measured by LARS score

Secondary objectives 3

1. To determine the efficacy of Vi-Siblin on overall and organ-specific HRQoL in LARS patients
2. To explore the difference between Vi-Siblin and placebo with respect to time to onset of effect on LARS symptoms
3. To explore the effect of Vi-Siblin on subgroups of LARS (frequency-dominated versus incontinence-dominated) and its effect on different LARS items

Conditions and MedDRA coding

Low anterior resection syndrome after low anterior resection for rectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant must be 18 ≥ years at the time of signing the informed concent
2. 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)
3. Any temporary stoma must be reversed at least 3 months before inclusion
4. Capable of giving signed informed concent as described in Appendix 1 in the protocoll
5. Ability to take oral interventional compound

Exclusion criteria 8

1. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. in the SmPC (sucrose, sodium chloride).
2. Difficulties swallowing or abnormal narrowing (stenosis) of the gastrointestinal tract, especially in the esophagus and cardia.
3. Suspected or known intestinal obstruction.
4. Intestinal paralysis or megacolon.
5. 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.
6. 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.
7. 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.
8. Various conditions rendering the participant unable to answer questionnaires.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Total LARS score 8 weeks after start of treatment

Secondary endpoints 3

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sykehuset Telemark HF

Sponsor organisation

Sykehuset Telemark HF

Address

Ulefossvegen 55

City

Skien

Postcode

3710

Country

Norway

Scientific contact point

Organisation

Sykehuset Telemark HF

Contact name

Forskningsavdelingen

Public contact point

Organisation

Sykehuset Telemark HF

Contact name

Forskningsavdelingen

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications