The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury (PRO-GIDSCI)

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:

• 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 Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Prebiotic

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudio Perret, Prof. Dr.; Phone Number: +41419396650; Email: claudio.perret@paraplegie.ch
• Study Contact Backup: Name: Anneke Hertig-Godeschalk, PhD; Phone Number: +41419396603; Email: anneke.hertig@paraplegie.ch

Study Locations

• Switzerland
  • Canton of Lucerne
    • Nottwil, Canton of Lucerne, Switzerland, 6207
      • Recruiting
      • Swiss Paraplegic Research
      • Contact: Anneke Hertig, PhD; Phone Number: +41419396603; Email: anneke.hertig@paraplegie.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic intervention; Probiotics add beneficial bacterial strains to the gut, which can restore microbial balance.	Dietary supplement: 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.
Active Comparator: Prebiotic intervention; Prebiotics, such as oat bran, selectively promote the growth of beneficial gut bacteria, particularly butyrate-producing species.	Dietary supplement: Prebiotic; Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal symptoms	Change in gastrointestinal symptoms using the Gastrointestinal Quality of Life (GIQLI) questionnaire.	Before and after eight weeks of intake of the dietary supplement.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome composition	Change in gut microbiome composition, assessed using a stool sample.	Before and after eight weeks of intake of the dietary supplement.
Inflammatory markers	Change in serum inflammatory markers, assessed by a blood sample.	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).	Before and after eight weeks of intake of the dietary supplement.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Occurrence of side effects of the supplementation, assessed by questioning.	After the eight weeks of intake of the dietary supplement.

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Investigators: Study Director: Jivko Stoyanov, Prof. Dr., Swiss Paraplegic Research, Nottwil

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: prebiotic; probiotic; dietary supplement; microbiome; gastrointestinal health
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Polysaccharides; Dietary Fiber; Polysaccharides, Bacterial; Probiotics; Prebiotics
• Other Study ID Numbers: 2024-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No