Spinal cord · 2019
Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Faber W X M, Nachtegaal J, Stolwijk-Swuste J M, Achterberg-Warmer W J, Koning C J M, Besseling-van der Vaart I, van Bennekom C A M
Аннотация
STUDY DESIGN: Multi-centre, double-blind randomised placebo-controlled study.
OBJECTIVE: To investigate whether the use of a multispecies probiotic can prevent antibiotic-associated diarrhoea in people with spinal cord injury (SCI).
SETTING: Three Dutch SCI rehabilitation centres.
METHODS: Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0). After cessation of the antibiotics (T1), the participants will use probiotics/placebo for 3 more weeks (T2). Defaecation, assessed by the Bristol Stool Scale, and bowel management will be monitored daily until 2 weeks after cessation of probiotics/placebo intake (T3). Also, the degree of nausea and information on quality of life will be collected at T0, T1, T2 and T3.
MAIN OUTCOME MEASURES: The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
SECONDARY OUTCOME MEASURES: The time to reach effective bowel management, degree of nausea and quality of life.
REGISTRATION: The Dutch Trial Register- NTR 5831.
OBJECTIVE: To investigate whether the use of a multispecies probiotic can prevent antibiotic-associated diarrhoea in people with spinal cord injury (SCI).
SETTING: Three Dutch SCI rehabilitation centres.
METHODS: Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0). After cessation of the antibiotics (T1), the participants will use probiotics/placebo for 3 more weeks (T2). Defaecation, assessed by the Bristol Stool Scale, and bowel management will be monitored daily until 2 weeks after cessation of probiotics/placebo intake (T3). Also, the degree of nausea and information on quality of life will be collected at T0, T1, T2 and T3.
MAIN OUTCOME MEASURES: The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
SECONDARY OUTCOME MEASURES: The time to reach effective bowel management, degree of nausea and quality of life.
REGISTRATION: The Dutch Trial Register- NTR 5831.