No registrations found.
ID
Source
Brief title
Health condition
Inflammatory bowel diseases: ulcerative colitis or Crohn's disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Safety, adverse events, clinical efficacy, need for prednisolone or anti-TNF rescue therapy, and hospitalization will be assessed.
Background summary
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.
Study objective
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.
Study design
Baseline: starting with antibiotics (Rifaximin) or CDED
3 months: follow-up moment
6 months: follow-up moment
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9859 |
| Other | METC Leiden Delft Den Haag : N.20.050 |