Probiotic and prebiotic supplements for digestive health after chronic spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Swiss Paraplegic Research
  Nottwil, Canton of Lucerne, Switzerland Recruiting

Study contacts

• Study coordinator: Claudio Perret, Prof. Dr.
• Email: claudio.perret@paraplegie.ch
• Phone: +41419396650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.