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RecruitingNCT06870331PRO-GIDSCIUpdated Oct 3, 2025

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

An interventional study of Probiotic and Prebiotic in Spinal Cord Injury, sponsored by Swiss Paraplegic Research, Nottwil. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Spinal Cord Injury

Keywords

  • probiotic
  • prebiotic
  • gastrointestinal health
  • microbiome
  • dietary supplement
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 50 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Swiss Paraplegic Research, Nottwil is the lead sponsor of 69 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Probiotic intervention

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

    Dietary Supplement: Probiotic

  • Active comparator
    Prebiotic intervention

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

    Dietary Supplement: Prebiotic

Interventions

  • Dietary supplementProbiotic

    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.

  • Dietary supplementPrebiotic

    Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.

06

What researchers measure

Primary outcomes

  1. Gastrointestinal symptoms

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

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

Secondary outcomes

  1. Gut microbiome composition

    Change in gut microbiome composition, assessed using a stool sample.

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

  2. Inflammatory markers

    Change in serum inflammatory markers, assessed by a blood sample.

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

  3. 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).

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

Other outcomes

  1. Side effects

    Occurrence of side effects of the supplementation, assessed by questioning.

    Time frame: After the eight weeks of intake of the dietary supplement.

07

Study locations

1 of 1 sites recruiting
  • Swiss Paraplegic Research
    Nottwil, Canton of Lucerne 6207, Switzerland
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06870331
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
Aug 11, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 3, 2025

Study contacts

Claudio Perret, Prof. Dr.
Contact
claudio.perret@paraplegie.ch
+41419396650
Anneke Hertig-Godeschalk, PhD
Contact
anneke.hertig@paraplegie.ch
+41419396603
Jivko Stoyanov, Prof. Dr.
study director · Swiss Paraplegic Research, Nottwil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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