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 study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Sykehuset I Vestfold HF	Tonsberg	Norway
Sorowpqsw Tckqxaie Hw	Skien	Norway
Avqgkyfu Uhglmahyon Hrrxmfqj	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not yet recruiting	01.06.2026

Trial locations

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.

Investigated diseases:

Low anterior resection syndrome

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 ID:

2024-514541-11-00

Protocol code:

Vi-SiTrial

Trial Phase:

Therapeutic exploratory (Phase II)

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