The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury
NCT ID: NCT06870331
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2025-08-11
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury
NCT04659408
to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD
NCT00324532
The Efficacy of a Probiotic for Functional Constipation (FC)
NCT06083311
Synbiotic, Prebiotics and Probiotics in Children With Cerebral Palsy and Constipation
NCT03117322
The Effect of Probiotic Intervention on Intestinal Permeability
NCT03027583
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Probiotic intervention
Probiotics add beneficial bacterial strains to the gut, which can restore microbial balance.
Probiotic
Participants will take one sachet BIOTICS-G (Burgerstein, Switzerland, 2.5 g) daily for eight weeks. The supplement contains 14 bacterial strains with a total viable cell count of 2.5 billion colony-forming units per sachet.
Prebiotic intervention
Prebiotics, such as oat bran, selectively promote the growth of beneficial gut bacteria, particularly butyrate-producing species.
Prebiotic
Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probiotic
Participants will take one sachet BIOTICS-G (Burgerstein, Switzerland, 2.5 g) daily for eight weeks. The supplement contains 14 bacterial strains with a total viable cell count of 2.5 billion colony-forming units per sachet.
Prebiotic
Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Swiss Paraplegic Research, Nottwil
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jivko Stoyanov, Prof. Dr.
Role: STUDY_DIRECTOR
Swiss Paraplegic Research, Nottwil
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Swiss Paraplegic Research
Nottwil, Canton of Lucerne, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-25
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.