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Clinical Trials/NL-OMON47019
NL-OMON47019RecruitingNot Applicable

Effect of a multispecies probiotic on bowel management in patients with spinal cord injury after use of antibiotics - Effect of probiotics on bowel management in SCI

Revalidatiecentrum Heliomare0 sites56 target enrollmentStarted: TBDLast updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
56

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • Patients should be confirmed with the diagnosis of spinal cord injury (SCI), first be admidded to a rehabilitation center after the occurrence of the SCI, aged between 18 and 75 years, and requiring treatment with antibiotics.

Exclusion Criteria

  • Exclusion criteria
  • - Known gastro-intestinal diseases
  • - Abdominal surgery within a year prior to study
  • - (Previous) radiotherapy or chemotherapy
  • - Severe auto immune diseases such as SLE and Sjogren
  • - Patients suffering from severe acute pancreatitis, multiple organ failure (MOF) or sepsis
  • - Patients receiving enteral feeding with the exception of nasogastric feeding
  • - Excessive alcohol intake (> 15 consumptions per week)
  • - (Planned) pregnancy or lactation
  • - Use of pre-, probiotics in the month before and during the study
  • - Use of antibiotics in the two weeks before the study
  • - More than one antibiotic treatment in the 6 month prior to the study.
  • - Previous participation in this study design
  • - Duration of antibiotics use longer than 10 days
  • - Antibiotic use of nitrofurantoin or trimethoprim, nitrofurantoine, flucloxacilline (very few to no antibiotics associated diarrhea has been shown in the general population)

Investigators

Sponsor
Revalidatiecentrum Heliomare

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