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.
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)
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
Crossover
Probiotic
Dietary supplementParticipants will take one sachet BIOTICS-G (Burgerstein, Switzerland, 2.5 g) daily for eight weeks. The supplement contains 14 bacterial strains with a total viable cell count of 2.5 billion colony-forming units per sachet.
Prebiotic
Dietary supplementParticipants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.
Gastrointestinal symptoms
Change in gastrointestinal symptoms using the Gastrointestinal Quality of Life (GIQLI) questionnaire.
Gut microbiome composition
Change in gut microbiome composition, assessed using a stool sample.
Inflammatory markers
Change in serum inflammatory markers, assessed by a blood sample.
Gastrointestinal transit time
Change in gastrointestinal transit time, assessed by the blue dye test (time from ingestion to first appearance of blue food dye in the stool).
Side effects
Occurrence of side effects of the supplementation, assessed by questioning.
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