Study on the Effects of GSL-01-001 for Patients with Irritable Bowel Syndrome (IBS) Type D

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What is this study about?

This clinical trial is focused on studying Irritable Bowel Syndrome with diarrhea (IBS-D), a condition that causes symptoms like abdominal pain, cramping, nausea, bloating, and diarrhea. The treatment being tested is a medication called GSL-01-001, which is taken orally. The purpose of the study is to evaluate how effective and safe this medication is in managing the symptoms associated with IBS-D.

The study will last for a total of 14 weeks, starting with a 2-week screening period followed by 12 weeks of treatment. During this time, participants will take the medication GSL-01-001 and will be monitored for any changes in their symptoms, as well as any side effects they might experience. The study aims to see if the medication can help reduce symptoms like abdominal pain, bloating, and diarrhea, and improve overall comfort and quality of life for those with IBS-D.

Participants will be asked to report on their symptoms regularly, and the study will track changes in things like abdominal pain and stool consistency. The safety of the medication will also be closely monitored throughout the study. This trial is an important step in understanding whether GSL-01-001 can be a helpful treatment option for people living with IBS-D.

1 screening period

The trial begins with a 2-week screening period to determine eligibility. During this time, eligibility criteria such as age, health status, and current medications are assessed.

Participants must be between 18 and 50 years old, have a diagnosis of Irritable Bowel Syndrome with diarrhea (IBS-D), and meet other specific health criteria.

2 start of treatment

Following the screening period, eligible participants begin the 12-week treatment phase.

The medication used is Arvisol 150mg, which contains cannabidiol. It is administered in tablet form and taken orally.

3 medication administration

Participants take the Arvisol 150mg tablet as directed by the study protocol. The specific dosage and frequency are determined by the study team and must be followed consistently throughout the trial.

4 monitoring and assessments

Throughout the 12-week treatment period, participants are monitored for changes in symptoms such as abdominal pain, cramping, nausea, bloating, and diarrhea.

Regular assessments are conducted to evaluate the effectiveness and safety of the treatment. This includes tracking changes in symptom severity and stool consistency.

5 end of treatment

At the end of the 12-week period, participants complete final assessments to evaluate the overall impact of the treatment on their symptoms.

The study aims to determine the effectiveness of the medication in controlling symptoms associated with IBS-D and to assess any side effects experienced during the trial.

Who Can Join the Study?

Must be between 18 and 50 years old, both males and females can participate.
Must be able to follow the study rules and complete the study.
Must understand the study and agree to participate by signing a consent form.
Must have a Body Mass Index (BMI) between 18 and 40. BMI is a measure of body fat based on height and weight.
Must have been diagnosed with Irritable Bowel Syndrome with diarrhea (IBS-D).
Must have an average abdominal pain score of 5.5 or higher at the start of the study.
If taking certain medications like antidepressants or sleep aids, the dosage must have been stable for 90 days before the study and must remain the same during the study.
Must have stable eating habits for the past 12 weeks and not plan to change lifestyle or diet during the study.
Female participants must be post-menopausal, sterilized, or have a negative pregnancy test if they can have children.
All participants who can have children must agree to use effective birth control during the study and for 30 days after the last dose of the study drug. Females using birth control pills must have started at least 30 days before the study. Surgical sterilization must have occurred at least 6 weeks before the study.
Male participants must agree not to donate sperm for 30 days after receiving the study drug.

Who Cannot Join the Study?

Patients who have a different type of Irritable Bowel Syndrome (IBS) than the one being studied, which is IBS with diarrhea.
Patients who are not within the specified age range for the study.
Patients who have other medical conditions that might interfere with the study.
Patients who are currently taking medications that could affect the study results.
Patients who have participated in another clinical trial recently.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergies or reactions to medications.
Patients who have a history of substance abuse or alcohol dependency.
Patients who are unable to comply with the study procedures or follow-up visits.
Patients who have any other condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Puywfh Nvmw Siu z ojkp	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	10.10.2024

Trial locations

Investigated drugs:

Cannabidiol

GSL-01-001 is an experimental medication being tested for its ability to manage symptoms associated with Irritable Bowel Syndrome (IBS) with diarrhea. This includes symptoms like abdominal pain, cramping, nausea, bloating, distention, diarrhea, and constipation. The trial aims to determine how effective and safe this medication is for patients experiencing these symptoms.

Investigated diseases:

Irritable bowel syndrome

Irritable Bowel Syndrome with Diarrhea (IBS-D) – This is a common disorder affecting the large intestine, characterized by a group of symptoms that include abdominal pain, cramping, bloating, and changes in bowel habits. In IBS-D, diarrhea is the predominant symptom, often accompanied by an urgent need to have a bowel movement. The condition can cause significant discomfort and may interfere with daily activities. Symptoms can vary in intensity and may be triggered by certain foods, stress, or hormonal changes. The exact cause of IBS-D is not well understood, but it is believed to involve a combination of gut-brain interactions, gut motility issues, and sensitivity to pain.

Trial ID:

2024-514685-39-00

Protocol code:

GSL-01-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of GSL-01-001 for Patients with Irritable Bowel Syndrome (IBS) Type D

What is this study about?

Who Can Join the Study?

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