Actively Recruiting
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury
Led by Swiss Paraplegic Research, Nottwil · Updated on 2025-10-03
50
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male or female
- Chronic spinal cord injury more than 1 year post-injury
- Para- or tetraplegia with ASIA Impairment Scale score A-D
- Significant gastrointestinal complaints confirmed at screening and GIQLI score below 110 at baseline
- Signed written informed consent
You will not qualify if you...
- Antibiotic use within 4 weeks before starting the study
- Major dietary changes within 4 weeks before starting the study, such as vegan or ketogenic diet
- Clinically relevant medical conditions like Crohn's disease or diagnosed eating or gastrointestinal disorders
- Use of significant medications including immunomodulating therapy, mesalazines, or steroids
- Participation in other clinical trials affecting gastrointestinal health
- Insufficient German language skills to follow study procedures
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Swiss Paraplegic Research
Nottwil, Canton of Lucerne, Switzerland, 6207
Actively Recruiting
Research Team
C
Claudio Perret, Prof. Dr.
CONTACT
A
Anneke Hertig-Godeschalk, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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