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Could a sugar alcohol replace the standard colonoscopy prep?

NCT ID NCT04759885

Disease control 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests mannitol, a sugar alcohol, as a bowel preparation for colonoscopy in 886 adults. It first finds the best dose, then compares it to the standard split-dose PEG solution. The goal is to see if mannitol cleans the bowel just as well and is safe.

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 it works, mannitol could offer a simpler, single-dose bowel preparation option for colonoscopy.
What could go wrong
This is an early-phase dose-finding study, so the best dose is still uncertain. Mannitol may not be as effective as the standard split-dose PEG solution.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

886 people

The number who actually took part.

Started

Jun 2020

Finished

Jul 2021

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 patient to consent and provide signed written informed consent 2. Age ≥ 18 years 3. Males and females scheduled for elective (screening, surveillance or diagnostic) colonoscopy to be prepared and performed according to the European Society of Gastrointestinal Endoscopy (ESGE) Guideline 4. Patients willing and able to complete the entire study and to comply with instructions Exclusion Criteria: 1. Pregnancy or breastfeeding. Females of childbearing potential must have a negative pregnancy test at Visit 2 and must practice one of the following methods of birth control throughout the study period (unless postmenopausal or surgically sterile, or whose sole sexual partner has had a successful vasectomy): oral, implantable, or injectable contraceptives (for a minimum of three months before study entry) in combination with a condom; intrauterine device in combination with a condom; double barrier method (condom and occlusive cap with spermicidal foam/gel/film/cream/suppository). 2. Severe renal failure: glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2 estimated by means of simplified MDRD equation. 3. Severe heart failure: NYHA Class III-IV. 4. Severe anaemia (Hb ≤ 8 g/dl). 5. Severe acute and chronically active Inflammatory Bowel Disease; patients in clinical remission (Crohn's Disease Activity Index - CDAI \< 150 for Crohn Disease and Partial Mayo Score ≤ 2 for Ulcerative Colitis) are allowed. 6. Chronic liver disease Child-Pugh class B or C. 7. Electrolyte disturbances (Na, Cl, K, Ca or P out of normal ranges). 8. Recent (\< 6 months) symptomatic acute ischemic heart disease. 9. 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. 10. Use of laxatives, colon motility altering drugs and/or other substances (e.g. simethicone) that can affect bowel cleansing or visibility during colonoscopy within 24 hours prior to colonoscopy. 11. Suspected bowel obstruction or perforation. 12. Indication for partial colonoscopy. 13. Patients who have received an investigational drug or therapy within 5 half-lives of the first visit. 14. Patients previously screened for participation in this study. 15. Hypersensitivity to the active ingredients or to any of the excipients of the study drugs. 16. Contraindication to Moviprep® (only for phase III).

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Conditions

The condition(s) this trial relates to.

Mucopolysaccharidosis IV

As listed by the trial registrant

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

Elective colonoscopy

Contacts and locations

Locations

  • ASSL Carbonia - Presidio Ospedaliero CTO di Iglesias

    Iglesias, CI, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162, Italy

  • ASST Rhodense - Presidi di Rho e Garbagnate

    Garbagnate Milanese, MI, 20024, Italy

  • ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

    Varese, 21100, Italy

  • Azienda Ospedaliero Universitaria Pisana- Ospedale Cisanello

    Pisa, PI, 56124, Italy

  • Azienda Ospedaliero-Universitaria Maggiore della Carità

    Novara, 28100, Italy

  • Azienda USL di Modena - Ospedale Ramazzini di Carpi

    Carpi, MO, 41012, Italy

  • Centre Hospitalier Henri Duffaut

    Avignon, France

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, France

  • Centro di Riferimento Oncologico IRCCS

    Aviano, PN, 33081, Italy

  • Clinical Hospital of Russian Railways N.A. Semashko

    Moscow, Russia

  • Fondazione Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, FG, 71013, Italy

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico di Milano

    Milan, MI, 20122, Italy

  • Fondazione Poliambulanza - Istituto Ospedaliero

    Brescia, BR, 25124, Italy

  • Hospices civils de Lyon

    Lyon, France

  • Hôpital Edouard Herriot

    Lyon, France

  • IRCCS "Saverio De Bellis"

    Castellana Grotte, BA, 70013, Italy

  • IRCCS Ospedale San Raffaele

    Milan, MI, Italy

  • IRCCS Policlinico San Donato

    San Donato Milanese, MI, 20097, Italy

  • Irkutsk State Medical Academy of Postgraduate Education

    Irkutsk, Russia

  • Istituto Europeo di Oncologia

    Milan, MI, Italy

  • Katholisches Klinikum Mainz

    Mainz, Germany

  • Klinikum Worms Medizinische Klinik II

    Worms, Germany

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, Germany

  • Medical Center of Diagnostics and Prevention

    Yaroslavl, Russia

  • Moscow Clinical Research and Practical Center of the Department of Health

    Moscow, Russia

  • Ospedale Sacro Cuore

    Negrar, VR, 37024, Italy

  • Ospedale Valduce

    Como, CO, Italy

  • Policlinico Universitario A. Gemelli

    Roma, RO, 00168, Italy

  • Praxis für Gastroenterologie und Fachärztliche Innere Medizin, Im Haus der Gesundheit

    Ludwigshafen am Rhein, Germany

  • Presidio Ospedaliero Santa Chiara

    Trento, TN, 38100, Italy

  • Private educational organization of higher education "Medical University "Reaviz"

    Samara, Russia

  • Railway Clinical Hospital

    Rostov-on-Don, Russia

  • Regional Oncological Clinical Hospital

    Yaroslavl, Russia

  • State Central Clinical Hospital A. N. Ryzhykh

    Moscow, Russia

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