The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss Paraplegic Research, Nottwil

About this trial

The goal of this clinical trial is to evaluate the effect of probiotic and prebiotic supplementation in individuals with chronic spinal cord injury experiencing gastrointestinal complaints.

The main questions this trail aims to answer are:

* what are the effects of the supplementation on gastrointestinal symptoms? * what are the effects of the supplementation on gut microbiome composition? * what are the effects of the supplementation on inflammatory serum markers? * what are the effects of the supplementation on gastrointestinal transit time?

Participants will:

* take either the probiotic or prebiotic supplement daily for eight weeks, followed by a four-week "wash-out period" (= no intake of either supplement) and a subsequent eight-week intake of the other supplement. * visit the study center for four appointments, during which various measurements will be performed.

Eligibility criteria

Qualifiers

Age: ≥ 18 years

Sex: male and female.

Chronic SCI (>1 year post-injury)

Individuals with para- and tetraplegia (American Spinal Cord Injury (ASIA) Impairment Scale (AIS) score A-D)

Disqualifiers

Antibiotic use within the last four weeks before starting the study

Major dietary changes within the last four weeks before starting the study, such as initiating a vegan or ketogenic diet

Presence of clinically relevant medical conditions, including Crohn's disease, diagnosed eating or gastrointestinal disorders, assessed on an individual basis

Intake of significant concomitant medication, including immunomodulating therapy, mesalazines, or steroids, assessed on an individual basis

Trial design

Treatments tested in this trial

  • Probiotic
  • Prebiotic

Treatment groups

50 Participants
are divided into 2 treatment groups