Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06870331

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

Led by Swiss Paraplegic Research, Nottwil · Updated on 2025-10-03

50

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Male or female
  • Chronic spinal cord injury more than 1 year post-injury
  • Para- or tetraplegia with ASIA Impairment Scale score A-D
  • Significant gastrointestinal complaints confirmed at screening and GIQLI score below 110 at baseline
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Antibiotic use within 4 weeks before starting the study
  • Major dietary changes within 4 weeks before starting the study, such as vegan or ketogenic diet
  • Clinically relevant medical conditions like Crohn's disease or diagnosed eating or gastrointestinal disorders
  • Use of significant medications including immunomodulating therapy, mesalazines, or steroids
  • Participation in other clinical trials affecting gastrointestinal health
  • Insufficient German language skills to follow study procedures
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, Switzerland, 6207

Actively Recruiting

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Research Team

C

Claudio Perret, Prof. Dr.

CONTACT

A

Anneke Hertig-Godeschalk, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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