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Could a simple sugar solution replace your colonoscopy prep?

NCT ID NCT07465705

Symptom relief Sponsor: NTC srl Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether mannitol, a sugar alcohol, works as well as the standard Plenvu for cleaning the bowel before a colonoscopy. About 412 adults scheduled for colonoscopy will be randomly assigned to take either mannitol or Plenvu. The goal is to see if mannitol provides adequate bowel cleansing, making it a potentially simpler or cheaper alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mannitol
What this could lead to
If mannitol works as well as Plenvu, it could offer a cheaper or more tolerable option for colonoscopy preparation.
What could go wrong
This is a non-inferiority trial, so mannitol may not be better—just not worse. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 412 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ability of subject to consent and provide signed written informed consent. 2. Age ≥ 18 years. 3. Males and females scheduled for elective colonoscopy performed according to ESGE guidelines. 4. Subjects willing and able to complete the entire study and to comply with instructions. Exclusion Criteria: 1. Pregnancy or breast feeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and practice highly effective methods of birth control throughout the study period, according to the CTCG "Recommendations related to contraception and pregnancy testing in clinical trials" v 1.2\* (unless postmenopausal or surgically sterile, or whose sole sexual partner had a successful vasectomy). 2. Severe acute and chronically active inflammatory bowel disease; subjects in clinical remission (Crohn's Disease Activity Index - CDAI \< 150 for Crohn Disease (Best et al. 1976) and Partial Mayo Score ≤ 2 for Ulcerative Colitis (Schroeder et al. 1987)) are allowed. 3. Severe renal failure: eGFR \< 30 ml/min/1.73 m2 estimated by simplified MDRD equation. 4. Severe heart failure: New York Heart Association (NYHA) Class III-IV. 5. Severe anaemia (Hb ≤ 8 g/dl). 6. Chronic liver disease Child-Pugh class B or C. 7. Electrolyte disturbances (baseline values of Na2+, Cl-, K+ out of normal ranges). 8. Clinically significant alterations of baseline haemato-chemical parameters. 9. Recent (\< 6 months) symptomatic acute ischemic heart disease. 10. History of significant gastrointestinal surgeries, including colon resection, sub-total colectomy, abdominoperineal resection, de-functioning colostomy or ileostomy, Hartmann's procedure and other surgeries involving the structure and function of the colon. 11. History of paralysis of the gut (ileus). 12. History of disorders of gastric emptying (e.g. gastroparesis, gastric retention, etc.). 13. History of phenylketonuria (due to presence of aspartame). 14. History of glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate). 15. History of toxic megacolon. 16. Use within 24 hours prior to colonoscopy of laxatives, colon motility altering drugs and/or other substances (e.g., simethicone) that could affect bowel cleansing or visibility during colonoscopy. 17. Suspected bowel obstruction or perforation. 18. Indication for partial colonoscopy. 19. Subjects who received an investigational drug or therapy within 5 half-lives of the first visit. 20. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs. 21. Underwater colonoscopy instead of standard gas insufflation.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Elective colonoscopy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Algemeen Ziekenhuis Damiaan Oostende

    RECRUITING

    Ostend, 8400, Belgium

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico

    RECRUITING

    Bologna, 40138, Italy

  • Azienda Provinciale Per I Servizi Sanitari

    RECRUITING

    Trento, 38122, Italy

  • Azienda Unita Sanitaria Locale Di Modena - Ospedale Ramazzini di Carpi

    RECRUITING

    Carpi, Modena, 41012, Italy

  • Centro Di Riferimento Oncologico Di Aviano

    RECRUITING

    Aviano, Pordenone, 33081, Italy

  • Congregazione Delle Suore Infermiere Dell'Addolorata - Ospedale Valduce

    RECRUITING

    Como, 22100, Italy

  • Fondazione IRCCS Cà Granda Ospedale Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fondazione Poliambulanza

    RECRUITING

    Brescia, 25124, Italy

  • H-T.Centrum Medyczne Sp. z o.o. sp.k.

    RECRUITING

    Tychy, 43-100, Poland

  • Hopital Erasme

    RECRUITING

    Anderlecht, 1070, Belgium

  • Hospital Clinic De Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • IRCCS Ospedale Sacro Cuore Don Calabria

    RECRUITING

    Negrar, Verona, 37024, Italy

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Katholieke Universiteit te Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Klinika Reuma Park Sp. z o.o. S.K.

    ACTIVE_NOT_RECRUITING

    Warsaw, 02-665, Poland

  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    RECRUITING

    Warsaw, 02-781, Poland

  • Policlinico Universitario A. Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Region Oerebro Laen

    RECRUITING

    Örebro, 701 85, Sweden

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