Spinal Cord InjuryPRO-GIDSCINCT06870331
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury
A study testing Probiotic and Prebiotic in people with Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Probiotic and Prebiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Aug 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Research
Nottwil, Canton of Lucerne, 6207
Anneke Hertig, PhD, +41419396603, anneke.hertig@paraplegie.ch
About this study
Official title: The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial
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:
Read more
- 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Probiotic, Prebiotic
- Keywords
- probiotic, prebiotic, gastrointestinal health, microbiome, dietary supplement
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
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.
PrebioticDietary supplement
Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic intervention | Experimental | Probiotics add beneficial bacterial strains to the gut, which can restore microbial balance. Receives: Dietary Supplement: Probiotic |
| Prebiotic intervention | Active comparator | Prebiotics, such as oat bran, selectively promote the growth of beneficial gut bacteria, particularly butyrate-producing species. Receives: Dietary Supplement: Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
Change in gastrointestinal symptoms using the Gastrointestinal Quality of Life (GIQLI) questionnaire.
Measured: Before and after eight weeks of intake of the dietary supplement.
Secondary outcomes (3)
Gut microbiome composition
Change in gut microbiome composition, assessed using a stool sample.
Measured: Before and after eight weeks of intake of the dietary supplement.
Inflammatory markers
Change in serum inflammatory markers, assessed by a blood sample.
Measured: Before and after eight weeks of intake of the dietary supplement.
Gastrointestinal transit time
Change in gastrointestinal transit time, assessed by the blue dye test (time from ingestion to first appearance of blue food dye in the stool).
Measured: Before and after eight weeks of intake of the dietary supplement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start11 Aug 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label two-arm randomized controlled crossover trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jivko Stoyanov, Prof. Dr., Study director, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870331
- Sponsor's protocol ID
- 2024-25
- Acronym
- PRO-GIDSCI
- Status last verified
- Oct 2025
- First submitted
- 5 Mar 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trunz J, Schmandt C, Hertig-Godeschalk A, Glisic M, Stoyanov J, Perret C. Probiotic and Prebiotic Supplementation for Gastrointestinal Discomfort in Chronic Spinal Cord Injury (PRO-GIDSCI): A Randomized Controlled Crossover Trial Protocol. Methods Protoc. 2026 Jan 17;9(1):14. doi: 10.3390/mps9010014.
PubMed 41562992
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT06870331
- Acronym / sponsor ID
- PRO-GIDSCI / 2024-25
- Conditions
- Spinal Cord Injury
- Keywords
- probiotic, prebiotic, gastrointestinal health, microbiome, dietary supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label two-arm randomized controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic intervention | Experimental | Dietary Supplement: ProbioticProbiotics add beneficial bacterial strains to the gut, which can restore microbial balance. |
| Prebiotic intervention | Active comparator | Dietary Supplement: PrebioticPrebiotics, such as oat bran, selectively promote the growth of beneficial gut bacteria, particularly butyrate-producing species. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticParticipants 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. | Dietary supplement | Probiotic intervention |
| PrebioticParticipants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks. | Dietary supplement | Prebiotic intervention |
Primary outcome
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.
3 secondary outcomes
Gut microbiome composition
Time frame: Before and after eight weeks of intake of the dietary supplement.
Inflammatory markers
Time frame: Before and after eight weeks of intake of the dietary supplement.
Gastrointestinal transit time
Time frame: Before and after eight weeks of intake of the dietary supplement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 41562992Trunz J, Schmandt C, Hertig-Godeschalk A, Glisic M, Stoyanov J, Perret C. Probiotic and Prebiotic Supplementation for Gastrointestinal Discomfort in Chronic Spinal Cord Injury (PRO-GIDSCI): A Randomized Controlled Crossover Trial Protocol. Methods Protoc. 2026 Jan 17;9(1):14. doi: 10.3390/mps9010014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jivko Stoyanov, Prof. Dr. study director
Swiss Paraplegic Research, Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Prebiotic in people with Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Perret, Prof. Dr. (+41419396650, claudio.perret@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal symptoms (time frame: Before and after eight weeks of intake of the dietary supplement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06870331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.