Microbiota targeted therapy as alternative for prednisolone and biologicals in IBD patients during the current COVID-19 threat
- Conditions
- Inflammatory bowel diseases: ulcerative colitis or Crohn's disease
- Registration Number
- NL-OMON25521
- Lead Sponsor
- estlé
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Safety, adverse events, clinical efficacy, need for prednisolone or anti-TNF rescue therapy, and hospitalization will be assessed.