This is a prospective registry to assess the safety and efficacy of off-label rifaximin or a dietary intervention as induction / maintenance therapy of IBD in times of COVID-19. The results of this prospective study may result in a safe treatment…
ID
Bron
Verkorte titel
Aandoening
Inflammatory bowel diseases: ulcerative colitis or Crohn's disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The results of this prospective study may result in a safe treatment protocol during future pandemics, in which an alternative of immunosuppressive medication may reappear.
Achtergrond van het onderzoek
This is a prospective registry to assess the safety and efficacy of off-label rifaximin or a dietary intervention as induction / maintenance therapy of IBD in times of COVID-19. Allocation to a treatment arm will be done based on clinical judgement of the treating physician in combination with shared decision making together with the patient.
Doel van het onderzoek
This is a prospective registry to assess the safety and efficacy of off-label rifaximin or a dietary intervention as induction / maintenance therapy of IBD in times of COVID-19. The results of this prospective study may result in a safe treatment protocol during future pandemics, in which an alternative of immunosuppressive medication may reappear.
Onderzoeksopzet
Baseline: starting with antibiotics (Rifaximin) or CDED
3 months: follow-up moment
6 months: follow-up moment
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
IBD patients - 18 years old - in patients where induction therapy is needed - chosen for one of the treatment options (antibiotic treatment or CDED), in consultation with the attending physician.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Severe activity of IBD urging for rescue treatment to avoid surgery, active fistulas as main indication for current induction therapy of CD, pouchitis, signs of active infectious gastro-enteritis/enterocolitis or other signs of infectious agents in stool sample, abnormal renal function (eGFR <30 ml/min), pre-existent leucopenia (<2) or thrombopenia (<50), liver cirrhosis with a MELD score >20, any other condition which in the opinion of the treating physician would make the patient unsuitable for treatment according to this protocol/enrollment.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9859 |
| Ander register | METC Leiden Delft Den Haag : N.20.050 |