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Microbiota targeted therapy as alternative for prednisolone and biologicals in IBD patients during the current COVID-19 threat

Microbiota targeted therapy as alternative for prednisolone and biologicals in IBD patients during the current COVID-19 threat: a prospective study addressing the safety of Budesonide in combination with rifaximin or the Crohns Disease Exclusion Diet (CDED)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25521
Enrollment
40
Registered
2021-08-23
Start date
2020-05-07
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel diseases: ulcerative colitis or Crohn's disease

Interventions

None listed

Sponsors

Nestlé
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Safety, adverse events, clinical efficacy, need for prednisolone or anti-TNF rescue therapy, and hospitalization will be assessed.

Contacts

Public ContactAndrea van der Meulen

Leiden University Medical Center

ae.meulen@lumc.nl071-5269111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)