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NCT Number: NCT06870331

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Location status: Recruiting

Location contact

Anneke Hertig, PhD

CONTACT

[email protected]

+41419396603

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Prebiotic

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Gut microbiome composition

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

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

  2. Inflammatory markers

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

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

  3. Gastrointestinal transit time

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

    Change in gastrointestinal transit time, assessed by the blue dye test (time from ingestion to first appearance of blue food dye in the stool).

Other outcomes

  1. Side effects

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anneke Hertig-Godeschalk, PhD

CONTACT

[email protected]

+41419396603

Claudio Perret, Prof. Dr.

CONTACT

[email protected]

+41419396650

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial

Acronym: PRO-GIDSCI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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