Spinal Cord Injury
Conditions
Keywords
probiotic, prebiotic, gastrointestinal health, microbiome, dietary supplement
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Participants 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.
DIETARY_SUPPLEMENTPrebiotic
Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.
Sponsors
Swiss Paraplegic Research, Nottwil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label two-arm randomized controlled crossover trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(at screening): * 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 criteria
(at screening): * 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 * Concurrent participation in other clinical trials investigating or potentially affecting GI health * Insufficient German language skills to follow the study procedures * Pregnancy (anamnestic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms | Before and after eight weeks of intake of the dietary supplement. | Change in gastrointestinal symptoms using the Gastrointestinal Quality of Life (GIQLI) questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome composition | Before and after eight weeks of intake of the dietary supplement. | Change in gut microbiome composition, assessed using a stool sample. |
| Inflammatory markers | Before and after eight weeks of intake of the dietary supplement. | Change in serum inflammatory markers, assessed by a blood sample. |
| Gastrointestinal transit time | Before and after eight weeks of intake of the dietary supplement. | Change in gastrointestinal transit time, assessed by the blue dye test (time from ingestion to first appearance of blue food dye in the stool). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side effects | After the eight weeks of intake of the dietary supplement. | Occurrence of side effects of the supplementation, assessed by questioning. |
Countries
Switzerland
Contacts
Primary ContactClaudio Perret, Prof. Dr.
Backup ContactAnneke Hertig-Godeschalk, PhD
Outcome results
None listed