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

NCT06870331 | Recruiting

• 1 other identifier: 2024-25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

probiotic; prebiotic; gastrointestinal health; microbiome; dietary supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gut microbiome composition

  Before and after eight weeks of intake of the dietary supplement.

• Inflammatory markers

  Before and after eight weeks of intake of the dietary supplement.

• Gastrointestinal transit time

  Before and after eight weeks of intake of the dietary supplement.

Other Outcomes (1)

• Side effects

  After the eight weeks of intake of the dietary supplement.

Study Arms (2)

Probiotic intervention

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Prebiotic intervention

ACTIVE COMPARATOR

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

Dietary Supplement: Prebiotic

Interventions

Probiotic DIETARY_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.

Probiotic intervention

Prebiotic DIETARY_SUPPLEMENT

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

Prebiotic intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 41562992 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Probiotics; Prebiotics

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Officials

• Jivko Stoyanov, Prof. Dr.

  Swiss Paraplegic Research, Nottwil

  STUDY DIRECTOR

Central Study Contacts

Claudio Perret, Prof. Dr.

CONTACT

+41419396650; claudio.perret@paraplegie.ch

Anneke Hertig-Godeschalk, PhD

CONTACT

+41419396603; anneke.hertig@paraplegie.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Open-label two-arm randomized controlled crossover trial

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)