Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could vitamin B3 tame gut inflammation?

NCT ID NCT06488625

Disease control Sponsor: University Hospital Schleswig-Holstein 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special form of vitamin B3 (nicotinamide) that releases in the lower gut to treat mild to moderate ulcerative colitis. About 459 adults will receive either a low or high dose of the vitamin or a placebo. The goal is to see if it can reduce symptoms and improve gut health without serious side effects.

What this could mean

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

Active substance
nicotinamide (vitamin B3) in a special capsule that releases it in the lower gut
What this could lead to
If it works, this could offer a new, well-tolerated treatment option for people with mild to moderate ulcerative colitis.
What could go wrong
This is an early-to-mid stage trial, so the treatment may not prove effective or safe. Results may not apply to all patients.

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

About 459 people

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

Started

Sep 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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: General: 1. Male and female patients with UC and 18 to 80 years of age (at the time of signing the informed consent). 2. Ability to understand and comply with the protocol. 3. Signed written informed consent. Disease-specific: 4. Documented diagnosis of UC, with a minimum disease duration of 3 months prior to screening and ≥ 1 relapse, clinically defined using established criteria within the last 12 months. 5. Histology supportive for the diagnosis of UC. 6. Mild to moderate disease activity (at screening): modified Mayo score (mMS) 4-7 RB ≥ 1, endoscopic score ES ≥1 and SF ≥ 1. 7. RHI \> 4 (at screening endoscopy). 8. Disease extent \>15 cm from the anal verge (at screening endoscopy). 9. Elevated level(s) of C-reactive protein (CRP) and/or faecal calprotectin during the screening period (levels above the reference range, measured by local laboratories). 10. Full colonoscopy with no signs of malignancy either during screening or within one year before screening. Medication: 11. In the case of no oral 5-ASA therapy within the last 2 weeks before entry into screening with informed consent, any prior oral 5-ASA therapy is permitted and the patient is not allowed to receive 5-ASA during the study. In the case of oral 5-ASA therapy within 2 weeks before entry into screening with informed consent, the 5-ASA therapy should have been ongoing for \> 3 months, should not be increased ≥ 4 weeks before screening endoscopy and should remain stable for ≥ 1 week before screening endoscopy at the maximum dose according to label or lower. This 5-ASA baseline medication must be kept stable in the induction period and may be reduced (but not increased again) in the maintenance period. In cases in which 5-ASA is dosed higher than the approved dose, the dose will be adjusted to the maximum approved dose at the time of randomization. Exclusion Criteria: General health and UC: 1. Diagnosis of CD, microscopic colitis, ischaemic colitis, radiation colitis or indeterminate colitis. 2. Infectious colitis, diverticulitis or segmental colitis associated with diverticulosis (SCAD) within the last 6 months before screening. 3. Current or past diagnosis of complex fistulae, intra-abdominal or peritoneal abscesses, strictures with obstructive symptoms. 4. Severe UC disease activity (modified Mayo score \>7). 5. Severe extraintestinal manifestations of UC requiring special treatment. 6. Steroid-dependent or steroid-refractory UC. 7. Foreseeable need for hospitalisation. 8. Previous colonic surgery, except for appendectomy. 9. Stools positive for enteric pathogens; Clostridium difficile toxin (CDT)-positive infection; indications for other relevant infections including cytomegalovirus colitis, each at screening. 10. Current or history of colon carcinoma, high grade colonic dysplasia or other malignancies except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin. 11. Moderate to severe anaemia (haemoglobin \<9 g/dL) at screening. 12. Moderate to severe renal impairment (glomerular filtration rate \<60) at screening. 13. Relevant bleeding or thrombotic disorders. 14. Alcohol or drug abuse within the last 2 years. Medications: 15. Rectal topical 5-ASA and/or rectal budesonide therapy (enemas, foams or suppositories) ≤ 2 weeks prior to screening endoscopy (up to 3 single doses allowed). 16. Use of oral corticosteroids and/or oral budesonide ≤ 4 weeks prior to screening endoscopy. 17. Previous use of immunosuppressants, Janus kinase inhibitors, sphingoside-1-phosphate receptor modulators or biologics. 18. Use of antibiotics for the treatment of UC or probiotic medication within 6 weeks prior to screening endoscopy. 19. Any need of parenteral therapies for the therapy of UC (except iron infusions). 20. Known hypersensitivity towards any component of the CICR-NAM or placebo tablets. Regulatory requirements 21. Participation in a clinical trial within 4 weeks prior to screening for this trial or intake of an investigational medicinal product (IMP) within the last 8 weeks or 5 half-lives (whichever is longer) prior to screening (or longer if necessary in the investigator's discretion). 22. Patients under legal supervision or guardianship, including patients, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 23. Patients who are dependent on the investigator or the sponsor. Other: 24. Pregnant or breastfeeding women. 25. Women of childbearing potential (WoCBP) not using highly effective contraception till at least 1 month after last dosing of IMP. 26. Male participants with female partners of childbearing potential who are not willing to use a highly effective contraception till at least 1 month after last dosing of IMP. 27. Indications that the patient may be unable to comply with the trial procedures, e.g. language barriers precluding adequate understanding or cooperation. 28. Any circumstances or medical conditions which could contradict a trial participation and lead the investigator to assess the patient as unsuitable for trial participation for any other reason.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Ulcerative colitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Ulcerative colitis, unspecified

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Agaplesion Frankfurter Diakonie Kliniken gGmbH

    RECRUITING

    Frankfurt am Main, 60431, Germany

  • Charite Universitaetsmedizin Berlin KöR

    RECRUITING

    Berlin, 10117, Germany

  • Charite Universitaetsmedizin Berlin KöR

    RECRUITING

    Berlin, 12203, Germany

  • DRK Kliniken Berlin

    RECRUITING

    Berlin, 12559, Germany

  • Evangelisches Krankenhaus Kalk gGmbH

    RECRUITING

    Cologne, 51103, Germany

  • Gastroenterologie am Herrengarten

    RECRUITING

    Darmstadt, 64293, Germany

  • Gastroenterologische Schwerpunktpraxis Prof. Dr. Ludwig & Dr. med. Güthle

    RECRUITING

    Dornstadt, 89160, Germany

  • Gastropraxis Magdeburg

    RECRUITING

    Magdeburg, 39104, Germany

  • Gastropraxis an der St. Barbara-Klinik

    RECRUITING

    Hamm, 59073, Germany

  • Gesundheit Nord gGmbH Klinikverbund Bremen

    RECRUITING

    Bremen, 28205, Germany

  • Goethe University Frankfurt

    RECRUITING

    Frankfurt, 60590, Germany

  • Martin-Luther-Universitaet Halle-Wittenberg

    RECRUITING

    Halle, 06120, Germany

  • Medical Care Unit Dachau

    WITHDRAWN

    Dachau, 85221, Germany

  • Practice for Gastroenterology

    RECRUITING

    Hanover, 30449, Germany

  • Private Practice for Gastroenterology

    RECRUITING

    Heidelberg, 69115, Germany

  • Sozialstiftung Bamberg

    RECRUITING

    Bamberg, 96049, Germany

  • St. Marien Und St. Annastiftskrankenhaus

    RECRUITING

    Ludwigshafen, 67067, Germany

  • Universitaet Muenster

    NOT_YET_RECRUITING

    Münster, 48149, Germany

  • Universitaetsklinikum Aachen AöR

    NOT_YET_RECRUITING

    Aachen, 52074, Germany

  • Universitaetsklinikum Augsburg

    RECRUITING

    Augsburg, 86156, Germany

  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

    RECRUITING

    Dresden, 01307, Germany

  • Universitaetsklinikum Schleswig-Holstein AöR

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitaetsklinikum Schleswig-Holstein AöR

    RECRUITING

    Lübeck, 23538, Germany

  • Universitaetsklinikum Ulm AöR

    RECRUITING

    Ulm, 89081, Germany

  • Universitat Heidelberg

    RECRUITING

    Mannheim, 68167, Germany

  • University Medical Center Hamburg-Eppendorf

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.