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

Not Applicable

Not yet recruiting

• Conditions: Spinal Cord Injury

• Registration Number: NCT06870331
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Study Start: 2025-06
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gut microbiome composition	Before and after eight weeks of intake of the dietary supplement.	Change in gut microbiome composition, assessed using a stool sample.
Inflammatory markers	Before and after eight weeks of intake of the dietary supplement.	Change in serum inflammatory markers, assessed by a blood sample.
Gastrointestinal transit time	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).

Trial Locations

Locations (1)

Swiss Paraplegic Research; 🇨🇭 Nottwil, LU, Switzerland