AuthorisedTherapeutic exploratory (Phase II)Interventional

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.

This research study is for people in the UK who have developed bowel problems, known as Low Anterior Resection Syndrome (LARS), after having surgery for rectal cancer. LARS can cause symptoms like needing to go to the toilet urgently or very often. The study wants to find out if a fibre supplement called Vi-Siblin can help ease these symptoms and improve how people feel day-to-day. Participants will be given either Vi-Siblin or a dummy powder (placebo) that looks the same but contains no active medicine. We will then compare the experiences of both groups to see if Vi-Siblin makes a real difference. This is an early-stage study, meaning we are exploring if this treatment shows promise.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sykehuset Telemark HF

Enrolment target

120

Start

27 Apr 2026

Low anterior resection syndrome after low anterior resection for rectal cancer

What is this study about?

This research study is about helping people who have had surgery for rectal cancer. Sometimes, after this type of surgery, people can develop bowel problems often called Low Anterior Resection Syndrome (LARS). This can mean things like needing to use the toilet very often, having little control over bowel movements, or feeling an urgent need to go. These problems can really affect daily life and how people feel.

The main goal of this study is to see if a fibre supplement called Vi-Siblin can make these LARS symptoms better. We are also looking at how it might improve someone's overall quality of life, meaning how well they feel and do their daily activities. To do this, the study will compare Vi-Siblin with a 'dummy' powder, called a placebo, which looks identical but has no active ingredients. This helps researchers understand if any improvements are genuinely due to the Vi-Siblin or just a general effect of being in a study.

This is a 'Phase II' study, which means it's an early step in testing a new treatment. We are exploring if Vi-Siblin is effective and safe enough to be studied more widely in the future. We will carefully measure how LARS symptoms change over eight weeks and also look at how people's quality of life is affected. Understanding whether a simple supplement like Vi-Siblin can help manage these difficult symptoms would be a big step forward.

Key takeaways

This study evaluates Vi-Siblin, a fibre supplement, for bowel problems (LARS) after rectal cancer surgery.
It compares Vi-Siblin to a dummy powder (placebo) to see if it improves symptoms and quality of life.
Participation involves taking powder daily for 8 weeks and attending clinic visits for assessments.
This is an early-stage study to explore if Vi-Siblin is effective.
You have the right to leave the study at any point without affecting your care.

Who may be eligible?

To be able to join this study, participants must be adult men or women, aged 18 years or older.

You would be considered for this study if you have been diagnosed with Low Anterior Resection Syndrome (LARS) after having surgery for rectal cancer. This means you are experiencing bowel-related difficulties that developed after your cancer surgery.

More specific details about your health and medical history would be checked by the study team to make sure it's safe and appropriate for you to take part. For instance, they would review your cancer treatment history and any other medications you are taking.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had surgery for rectal cancer?
Do you experience bowel problems (LARS) after your surgery?
Are you able to take a daily powder supplement for 8 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve a few steps over several weeks. Firstly, you would have an initial visit where the study team would check if you are suitable. If you are, you would then start taking either the Vi-Siblin fibre supplement or the dummy powder daily for eight weeks. You wouldn't know which one you are taking, and neither would your doctor.

During these eight weeks, you would mostly be taking your allocated powder at home. You would likely have a few visits to the clinic with the research team. At these visits, they would monitor your progress and assess your LARS symptoms. This might involve filling out questionnaires about your bowel habits and how you are feeling. The main assessment will be at the end of the eight weeks, to see how your symptoms have changed. There might also be follow-up checks to understand the lasting effects.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the Vi-Siblin helps to reduce your LARS symptoms and improve your quality of life. However, as with all studies, there are potential risks, such as mild side effects from the supplement (like bloating or gas), or the possibility that the treatment may not help you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is Low Anterior Resection Syndrome (LARS)?

LARS is a collection of bowel problems that can develop after surgery for rectal cancer, like needing to rush to the toilet, going very often, or having difficulty controlling bowel movements.

What is Vi-Siblin?

Vi-Siblin is a type of fibre supplement. Fibre can help regulate bowel movements and make stools softer or firmer, depending on what's needed.

What is a 'dummy powder' or placebo?

A dummy powder (placebo) looks exactly like the real medicine but contains no active ingredients. It helps researchers know if the real medicine is actually causing any changes.

How long will I be in the study?

You will be taking the study powder daily for eight weeks, with assessments at the start, during, and at the end of this period. There may also be some follow-up checks.

Will I know if I'm getting the real medicine or the dummy powder?

No, neither you nor your doctors will know whether you are receiving Vi-Siblin or the dummy powder. This is called 'double-blind' and helps ensure the study results are fair.