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A study to evaluate the effectiveness of ispaghula husk in patients with low anterior resection syndrome after rectal cancer surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Low Anterior Resection Syndrome, which is a group of bowel symptoms that can occur after surgery for rectal cancer. These symptoms often involve changes in bowel habits and bladder control. The purpose of the study is to evaluate the effectiveness of a treatment called Vi-Siblin, which contains ispaghula husk, in managing these symptoms and improving the daily life of patients.

Participants in this research will be assigned to receive either Vi-Siblin granules or a placebo. This is done through a process where neither the participants nor the researchers know which substance is being given. The study involves taking the granules by mouth over a period of time to see how they affect the severity of the symptoms and the overall quality of life.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of treatment

    You will receive either vi-siblin granulat, which contains ispaghula husk, or a placebo (a substance with no active medicine).

    The ispaghula husk is a type of fiber taken by mouth in the form of granules.

  2. Step 2

    Treatment period

    The treatment lasts for a total of 8 weeks.

    During this time, your lars score, which measures the symptoms of low anterior resection syndrome (a set of bowel symptoms following rectal cancer surgery), will be monitored.

  3. Step 3

    Evaluation

    After 8 weeks of taking the granules, your lars score and your health-related quality of life (how your health affects your daily life) will be assessed to determine the effects of the treatment.

Who can join the trial?

7 criteria

  • You must be 18 years of age or older at the time of signing the permission form.
  • You must have experienced Low Anterior Resection Syndrome (LARS), which is a set of bowel symptoms that can happen after surgery for rectal cancer.
  • Your LARS score, which is a measurement used to track the severity of your symptoms, must be greater than 20 at least 12 months after your surgery.
  • You must have had sphincter-preserving surgery, which is a type of operation for rectal cancer that tries to save the muscle used to control bowel movements.
  • If you had a stoma, which is a surgically created opening on the abdomen to allow waste to leave the body, it must have been closed or reversed at least 3 months before starting the study.
  • You must be able to provide informed consent, meaning you understand the study details and sign a document agreeing to participate.
  • You must be able to swallow and take oral medication, which is medicine taken by mouth.

Who cannot join the trial?

9 criteria

  • You cannot join if you have an allergy or hypersensitivity (an extreme reaction) to the main medicine or any of its ingredients, such as sucrose (sugar) or sodium chloride (salt).
  • You are not eligible if you have difficulty swallowing or stenosis (an abnormal narrowing) in your digestive tract, particularly in the esophagus (the tube connecting the throat to the stomach) or the cardia (the opening at the top of the stomach).
  • You cannot participate if you have a suspected or known intestinal obstruction (a blockage in the intestines that prevents food or liquid from passing through).
  • You are excluded if you have intestinal paralysis (when the muscles in the intestines stop moving properly) or megacolon (an abnormal enlargement of the large intestine).
  • You cannot join if you have rare, congenital (conditions present from birth) medical issues, such as inherited fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency (conditions where the body cannot properly process certain sugars).
  • Patients with diabetes who are taking medicine to manage their blood sugar, or patients taking thyroid hormone treatments, may be excluded unless they are under very close medical supervision, as the study medicine might require changes to those treatments.
  • You cannot participate if you are currently using or have previously used other treatments to regulate your bowel movements that work similarly to the study medicine.
  • You are excluded if you use medicines that inhibit intestinal peristalsis (drugs that slow down the natural wave-like muscle contractions that move food through the digestive tract).
  • You cannot join if you have any condition that prevents you from being able to complete and answer the study questionnaires.
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Investigated drugs

Vi-Siblin is a supplement made from ispaghula husk, which is a type of fiber. It is taken by mouth in the form of granules and is being studied to see if it can help reduce symptoms in people experiencing digestive issues after rectal cancer surgery.

What is already known about the treatment

  • Vi-Siblin granulat

    This medication is taken orally in the form of granules that are mixed with liquid. It contains ispaghula husk, a well-known natural fiber that has been widely used in medicine for many years to help manage digestion. It works by absorbing water in the intestines to increase stool bulk and soften its consistency, making bowel movements more regular and easier to control. This substance is classified as a bulk-forming laxative and is used to help improve symptoms related to bowel irregularities.

  • Placebo powder

    This is an inactive substance administered orally in a powder form that looks and feels like the test medication. It contains no active medicinal ingredients and is used in clinical trials as a control to compare against the actual treatment. Because it has no therapeutic effect, it serves as a baseline to help researchers determine if the test medication truly works.

Investigated diseases

Low anterior resection syndrome - This condition occurs in individuals who have undergone surgery to remove a portion of the rectum. It is characterized by changes in bowel habits and bladder function. Symptoms typically include frequent bowel movements, an urgent need to go to the bathroom, and difficulty controlling bowel movements. The condition can progress to include increased frequency of stool evacuation and liquid stools. It often involves a lack of control over bowel movements, known as fecal incontinence.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514541-11-00Protocol codeVi-SiTrialEstimated enrolment120 patients

sourced from the EU Clinical Trials Register and site verification

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