Probiotic and prebiotic supplements for digestive health after chronic spinal cord injury
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial
This trial will test whether taking a probiotic or a prebiotic can improve digestive symptoms, gut microbiome balance, inflammation, and transit time in adults with long-term spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swiss Paraplegic Research, Nottwil Research network |
| Locations | 1 site (Nottwil, Canton of Lucerne) |
| Trial ID | NCT06870331 on ClinicalTrials.gov |
What this trial studies
This single-center crossover interventional trial enrolls adults with chronic spinal cord injury who report significant gastrointestinal complaints. Participants will take either a probiotic or a prebiotic daily for eight weeks, have a four-week washout, then take the other supplement for eight weeks, with four study visits for measurements. Outcomes include gastrointestinal symptom scores, gut microbiome composition, inflammatory serum markers, and gastrointestinal transit time. The study is conducted at Swiss Paraplegic Research in Nottwil and excludes recent antibiotic use or major recent dietary changes.
Who should consider this trial
Good fit: Adults (≥18 years) with chronic (>1 year) spinal cord injury (para- or tetraplegia, AIS A–D) who have significant gastrointestinal complaints (GIQLI score below 110) and can attend the study center are ideal candidates.
Not a fit: People who recently used antibiotics, made major diet changes within four weeks, have active inflammatory bowel disease or other significant gastrointestinal disorders, or are on certain immunomodulating medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the supplements could reduce gastrointestinal symptoms, favorably change the gut microbiome, lower inflammatory markers, and improve bowel transit for people with chronic spinal cord injury.
How similar studies have performed: Some prior studies in other populations show probiotics or prebiotics can alter the microbiome and improve gut symptoms, but evidence specific to chronic spinal cord injury is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Nottwil, Canton of Lucerne
- Swiss Paraplegic Research — Nottwil, Canton of Lucerne, Switzerland (Recruiting)
Study contacts
- Study coordinator: Claudio Perret, Prof. Dr.
- Email: claudio.perret@paraplegie.ch
- Phone: +41419396650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.