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

NCT06870331 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-03

No results posted yet for this 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.

Conditions

  • Spinal Cord Injury

Interventions

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.

DIETARY_SUPPLEMENT

Prebiotic

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

Sponsors & Collaborators

  • Swiss Paraplegic Research, Nottwil

    lead NETWORK

Principal Investigators

  • Jivko Stoyanov, Prof. Dr. · Swiss Paraplegic Research, Nottwil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06870331 on ClinicalTrials.gov