The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury
Key facts
- Where
- Nottwil, SwitzerlandSee the site
Where in Switzerland
- Swiss Paraplegic ResearchNottwil, SwitzerlandContact: Anneke Hertig, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Swiss Paraplegic Research, Nottwil
- Trial code
- NCT06870331
- Record updated
- 3 October 2025
- Original description
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.Read full original descriptionShow less
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover 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.
Inclusion: 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); Having significant gastrointestinal complaints, indicated with "yes" at screening and by a GIQLI questionnaire score below 110 at baseline; Signed written informed consent.
Exclusion: 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; Intake of significant concomitant medication, including immunomodulating therapy, mesalazines, or steroids, assessed on an individual basis; Concurrent participation in other clinical trials investigating or potentially affecting GI health; Presence of clinically relevant medical conditions, including Crohn's disease, diagnosed eating or gastrointestinal disorders, assessed on an individual basis; Insufficient German language skills to follow the study procedures; Pregnancy (anamnestic).