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.

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.