Spinal cord injury
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibiotic associated diarrhoea, defined as three or more liquid stools (Bristol stool scale score 5, 6 or 7) per day for three or more days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach proper bowel management, defecation frequency, faecel consistency, quality of life. | — |
Countries
Netherlands