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Clinical Trials/NCT06870331
NCT06870331RecruitingNot Applicable

The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial

Swiss Paraplegic Research, Nottwil2 sites in 1 country50 target enrollmentStarted: August 11, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Gastrointestinal symptoms
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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)

Arms & Interventions

Prebiotic intervention

Active Comparator

Prebiotics, such as oat bran, selectively promote the growth of beneficial gut bacteria, particularly butyrate-producing species.

Intervention: Prebiotic (Dietary Supplement)

Probiotic intervention

Experimental

Probiotics add beneficial bacterial strains to the gut, which can restore microbial balance.

Intervention: Probiotic (Dietary Supplement)

Outcomes

Primary Outcomes

Gastrointestinal symptoms

Time Frame: Before and after eight weeks of intake of the dietary supplement.

Change in gastrointestinal symptoms using the Gastrointestinal Quality of Life (GIQLI) questionnaire.

Secondary Outcomes

  • Gut microbiome composition(Before and after eight weeks of intake of the dietary supplement.)
  • Inflammatory markers(Before and after eight weeks of intake of the dietary supplement.)
  • Gastrointestinal transit time(Before and after eight weeks of intake of the dietary supplement.)

Investigators

Sponsor
Swiss Paraplegic Research, Nottwil
Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (2)

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