Efficacy and Safety of Mannitol Compared to Plenvu for Bowel Preparation in Patients Undergoing Elective Colonoscopy

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What is this study about?

This study evaluates the effectiveness of two different bowel preparation methods for patients undergoing elective colonoscopy. A colonoscopy is a procedure where a doctor examines the lining of the large intestine (colon) using a flexible tube with a camera. Before this procedure, the bowel must be thoroughly cleaned to allow clear visualization. The study compares mannitol (a type of sugar alcohol used as a bowel cleanser) with Plenvu® (a commercially available bowel preparation solution) to determine if mannitol works at least as well as Plenvu® for cleaning the bowel.

The purpose of this research is to show that mannitol is not inferior to Plenvu® when used as a same-day bowel preparation regimen before colonoscopy. Participants will be randomly assigned to use either mannitol or Plenvu® to clean their bowels before their scheduled colonoscopy. The endoscopist (the doctor performing the colonoscopy) will not know which preparation each patient received, allowing for an unbiased assessment of how clean the bowel is during the procedure.

During the study, patients will take their assigned bowel preparation according to instructions, undergo their scheduled colonoscopy, and answer questions about their experience with the preparation, including ease of use, taste, and willingness to use it again. The study will also monitor for any side effects from either preparation and collect information about how well each preparation cleaned the bowel and allowed for detection of any abnormalities.

1 Randomization into Treatment Groups

After joining the study, you will be randomly assigned to receive either mannitol or Plenvu® for bowel preparation before your colonoscopy.

Both medications are designed to cleanse your bowel before the procedure, but they contain different active ingredients.

2 Preparation Instructions

You will receive detailed instructions on how to take your assigned bowel preparation medication.

The study follows a same-day dosing regimen, which means you will take the preparation on the same day as your colonoscopy.

You will need to carefully follow all provided instructions regarding timing, food restrictions, and fluid intake.

3 Taking the Bowel Preparation

Depending on your assigned group, you will take either mannitol (study medication) or Plenvu® (standard medication).

Plenvu® contains macrogol 4000, sodium sulfate, sodium chloride, potassium chloride, sodium hydrogen carbonate, and simeticone.

Mannitol is an alternative bowel cleansing solution.

Both medications are administered as oral solutions that you will drink according to the provided schedule.

4 Laboratory Tests

Blood samples will be collected before you take the medication (baseline), and then 4 hours and 8 hours after you complete taking the bowel preparation.

These tests will check various blood parameters to monitor how your body responds to the preparation.

Some participants may be included in a special pharmacokinetic (PK) sub-study, which involves additional blood samples to measure how the medication moves through your body.

5 Vital Signs Monitoring

Your vital signs (heart rate, blood pressure) will be measured before taking the medication and at various points during the study.

During the colonoscopy, your oxygen levels will also be monitored.

6 Colonoscopy Procedure

You will undergo a colonoscopy (examination of the large intestine using a flexible tube with a camera) according to standard guidelines.

The doctor performing the colonoscopy will not know which bowel preparation you received (this is called ‘endoscopist-blinded’).

During the procedure, the doctor will assess how clean your bowel is using the Boston Bowel Preparation Scale (BBPS), check for bubbles using the Colon Endoscopic Bubble Scale (CEBuS), and look for any abnormal findings.

If any suspicious areas are found, tissue samples may be taken for further examination.

7 Feedback Questionnaires

After completing the preparation and procedure, you will be asked to provide feedback on your experience.

You will rate the ease of use and taste of the preparation on a numeric scale from 0 to 10.

You will also be asked whether you would be willing to use the same preparation again in the future.

If you have had a previous colonoscopy, you will be asked to compare this preparation to the one you used before.

8 Monitoring for Side Effects

Throughout the study, any adverse events (unwanted side effects) will be recorded.

These include any health issues that start from the time you begin taking the study medication.

The study team will determine whether these events are related to the study medication.

9 Follow-up

The study will assess whether your colonoscopy was successful or if you need to repeat the procedure due to inadequate bowel cleansing.

The results of any tissue samples taken during your colonoscopy will be recorded as part of the study data.

Who Can Join the Study?

You must be scheduled for an elective colonoscopy (a planned examination of the large intestine) performed according to ESGE guidelines (standard European medical recommendations for this procedure)
You must be able to understand and provide written informed consent (give your permission in writing after understanding the study)
You must be at least 18 years of age or older
You can be either male or female
You must be willing and able to complete the entire study and follow all instructions given

Who Cannot Join the Study?

You cannot participate in the study if you have a known allergy to mannitol or Plenvu (these are bowel cleansing medications).
If you have severe kidney problems that affect how your body processes fluids and medications.
If you have a bowel obstruction (blockage in your intestines that prevents stool from passing through).
If you have inflammatory bowel disease (chronic conditions like Crohn’s disease or ulcerative colitis that cause inflammation in your digestive tract).
If you have had previous bowel surgery that significantly changed your digestive anatomy.
If you are pregnant or breastfeeding.
If you have severe heart failure (when your heart cannot pump blood effectively).
If you cannot follow instructions or complete the bowel preparation process independently.
If you are currently participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Region Oerebro Laen	Orebro	Sweden
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Algemeen Ziekenhuis Damiaan Oostende	Ostend	Belgium
Fondazione Poliambulanza	Brescia	Italy
Azienda Unita Sanitaria Locale Di Modena	Carpi	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
H-T. Centrum Medyczne Sp. z o.o.	Tychy	Poland
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
Cwcvlctvhomoi Dcmiv Sjtkv Ibtbfffmbz Djxubozudweowwxugpdhs	Como	Italy
Nhlnslzq Iicqrsdq Ojxqsyzeh Idn Mrofi Suhfbcavzopplembrrdnrwaphhnz Ijapeqim Btrjxegw	Cracow	Poland
Afrovvq Umqza Sdjnrcdgz Loearu Dq Bgfayhf	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.07.2025
Italy	Not recruiting	01.07.2025
Poland	Not recruiting	01.07.2025
Spain	Not recruiting	01.07.2025
Sweden	Not recruiting	01.07.2025

Trial locations

Investigated drugs:

Mannitol is a sugar alcohol that is used as a bowel preparation medication. It works by drawing water into the intestines, which helps to cleanse the bowel by producing watery diarrhea. This helps to clear the colon so that the doctor can see the inside walls of the colon clearly during a colonoscopy.

Plenvu is a bowel preparation medication used before colonoscopy procedures. It contains a combination of ingredients that work together to cleanse the bowel by causing diarrhea. This helps to empty and clean the colon so that the doctor can have a clear view during the examination.

Investigated diseases:

Colonoscopy

Inflammatory Bowel Disease (IBD) – IBD is a group of chronic inflammatory conditions that affect the digestive tract. It primarily includes Crohn’s disease and ulcerative colitis, which are characterized by periods of active disease (flares) and remission. In IBD, the immune system mistakenly attacks the intestinal tissues, causing inflammation, damage, and ulceration of the digestive tract lining. Symptoms typically include persistent diarrhea, abdominal pain, rectal bleeding, weight loss, and fatigue. The disease can progressively worsen over time, causing structural damage to the intestines and potentially affecting nutrient absorption.

Colorectal Neoplasia – Colorectal neoplasia refers to abnormal tissue growths in the colon or rectum that range from benign polyps to malignant tumors. These growths begin as small, noncancerous polyps that form on the inner lining of the colon or rectum. Over time, some polyps can progressively transform into cancer through a series of genetic mutations. Adenomas are a specific type of polyp with higher potential to develop into cancer. Colorectal neoplasia often develops without causing symptoms in early stages, which is why screening is important for detection before progression.

Trial ID:

2025-521451-23-00

Protocol code:

Mannitol_01-2024

Trial Phase:

Therapeutic confirmatory (Phase III)

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Efficacy and Safety of Mannitol Compared to Plenvu for Bowel Preparation in Patients Undergoing Elective Colonoscopy

What is this study about?

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