Clinical trial NCT06870331: The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury
Official title: The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: probiotic
prebiotic
gastrointestinal health
microbiome
dietary supplement
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2025-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open-label two-arm randomized controlled crossover trial
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: Before and after eight weeks of intake of the dietary supplement.
Secondary outcomes:
measure: Gut microbiome composition
timeFrame: Before and after eight weeks of intake of the dietary supplement.
measure: Inflammatory markers
timeFrame: Before and after eight weeks of intake of the dietary supplement.
measure: Gastrointestinal transit time
timeFrame: Before and after eight weeks of intake of the dietary supplement.
Other outcomes:
measure: Side effects
timeFrame: After the eight weeks of intake of the dietary supplement.
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Research
state: LU
Study officials:
affiliation: Swiss Paraplegic Research, Nottwil
name: Jivko Stoyanov, Prof. Dr.
role: STUDY_DIRECTOR
References: