Effect of probiotics on bowel management in SCI

Antibiotic-associated diarrhea is a common complication in antibiotic use in patients with a spinal cord injury. Diarrhea primarily leads to feelings of general discomfort and, as as a result, patients might be delayed in their rehabilitation after spinal cord injury. The objective of this study is to investigate whether the use of probiotics can decrease faecal incontinence and positively influence the bowel management regimen in inpatients with a spinal cord injury treated with antibiotics. The use of probiotics will be double-blind controlled with a placebo. The primary outcome that will be compared between the intervention and placebo group is the incidence of faecal incontinence, defined by frequency, consistency, and (un)wanted defecation. Secondary outcome measures are quality of life and nausea.

In this double-blind randomized placebo-controlled trial, we hypothesize to observe a reduced incidence of antibiotic associated diarrhae (AAD) in inpatients with a spinal cord injury (SCI) during the intake of probiotics, in comparison to a placebo, when antibiotic treatment is provided.

T0 = start of intervention: start use of antibiotics together with probiotics or the placebo

T1 = last day of use of antibiotics (between 5 and 10 days after T0)

T2 = last day of use of probiotics (2 weeks after T1)

T3 = end of follow-up period (2 weeks after T2)

Participants will be randomly assigned to receive both an antibiotic treatment and Ecologic® AAD, or an antibiotic treatment and a placebo. Subjects will receive either probiotic or placebo for 26-31 days (depending on the length of antibiotic treatment; 5-10 days); starting together with the antibiotic treatment and ending three weeks after cessation.