To investigate whether the use of a probiotic can decrease antibiotic associated diarrhoea and positively influences the bowel management regimen of SCI patients treated with antibiotics.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Time to reach proper bowel management, defecation frequency, faecel
consistency, quality of life.
Background summary
Spinal Cord Injury (SCI) often results in a neurogenic bowel and frequent
requirement of antibiotic treatment. Therefore, these patients are at high risk
of developing antibiotic related bowel problems, such as diarrhoea. Probiotics
have clearly shown to prevent/treat antibiotic associated diarrhoea but studies
investigating the effect in SCI patients are lacking.
Study objective
To investigate whether the use of a probiotic can decrease antibiotic
associated diarrhoea and positively influences the bowel management regimen of
SCI patients treated with antibiotics.
Study design
Double-blind randomized placebo-controlled study
Intervention
Probiotics or placebo
Study burden and risks
The probiotic mixture is available on the Dutch market and several
international markets (Austria, Germany, Russia, Slovenia, Norway, Ukraine and
Greece) for the reduction of antibiotic associated side effects . The lactic
acid bacteria in the mixture carry the European Union Qualified Presumption of
Safety (QPS) or have an extensive safety record. No side effects are expected.
No invasive measurements are performed.
Relweg 51
Wijk aan Zee 1949EC
NL
Relweg 51
Wijk aan Zee 1949EC
NL
Listed location countries
Age
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)
Design
Recruitment
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 |
|---|---|
| Other | Nederlands Trial Register (in behandeling) |
| CCMO | NL57438.029.16 |