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

Spinal Cord, 2020 · DOI: 10.1038/s41393-019-0369-y · Published: November 11, 2019

Spinal Cord Injury Gastroenterology Rehabilitation

Simple Explanation

This study aims to determine if a multispecies probiotic can prevent antibiotic-associated diarrhea (AAD) in people with spinal cord injury (SCI) undergoing inpatient rehabilitation. The study will also investigate if the probiotic shortens the time to achieve effective bowel management, prevents nausea, and improves quality of life. Participants will be randomly assigned to receive either a multispecies probiotic or a placebo, along with antibiotics, and will be monitored for bowel function, nausea, and quality of life.

Study Duration

Not specified

Participants

56 people aged 18–75 years with SCI

Evidence Level

Randomized placebo-controlled study

Key Findings

1
The primary outcome is the difference in the incidence of AAD between the probiotic and placebo groups at the end of antibiotic use, probiotic use, and two weeks thereafter.
2
Secondary outcomes include the time to reach effective bowel management, the degree of nausea experienced, and the participants' quality of life.
3
The study uses the Bristol Stool Scale to assess defaecation and bowel management will be monitored daily.

Research Summary

Neurogenic bowel dysfunction is one of the most disabling impairments caused by SCI and achieving effective bowel management is a lifelong challenge. People with SCI are at risk of developing infections that require antibiotic treatment and therefore at risk of developing AAD. When completed, this study will be the ﬁrst randomised placebo-controlled trial on preventing AAD in people with SCI. As such, our study is of great importance.

Practical Implications

Clinical Practice

The findings could influence the use of probiotics in SCI patients undergoing antibiotic treatment to prevent AAD.

Quality of Life

Successful prevention of AAD and improvement in bowel management could significantly enhance the quality of life for SCI patients.

Rehabilitation Outcomes

Reducing AAD may improve the rehabilitation process and lead to better overall outcomes for SCI patients.

Study Limitations

1
Data on the prevalence of AAD in persons with SCI are limited.
2
Participants who receive less than 75% of the recommended dose of multispecies probiotic or placebo will be considered as non-compliant.
3
The study is limited to three rehabilitation centers in the Netherlands.

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