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NCT06870331 | NOT YET RECRUITING | Spinal Cord Injury

The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury
Sponsor:

Swiss Paraplegic Research, Nottwil

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.

Condition or disease

Spinal Cord Injury

Intervention/treatment

Probiotic

Prebiotic

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury

Location Details

NCT06870331

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Switzerland, LU

Swiss Paraplegic Research

Nottwil, LU, Switzerland, 6207