Effects of Probiotic and Prebiotic Supplements on Gastrointestinal Health in Individuals with Chronic Spinal Cord Injury
Zusammenfassung der Studie
In this study, we investigate whether commercially available probiotic and prebiotic supplements can positively affect gastrointestinal health in individuals with chronic spinal cord injury. In our study, participants are randomly assigned to groups. This is important to obtain reliable results from the study. Each group receives either the probiotic supplement first and then the prebiotic supplement, or vice versa. During the study, participants will take one of the two supplements daily for eight weeks. After that, there is a four-week break during which no supplements are taken, before taking the other supplement daily for another eight weeks.
(BASEC)
Untersuchte Intervention
The probiotic used is 'BIOTICS-G' (Sachet of 2.5 g, Burgerstein), a commercially available supplement. The prebiotic used is the commercially available food 'Oat Bran' (5 g, Naturaplan Bio, Coop).
(BASEC)
Untersuchte Krankheit(en)
Gastrointestinal complaints in individuals with chronic spinal cord injury
(BASEC)
-Age 18 years or older -Chronic spinal cord injury (> 1 year) -Gastrointestinal complaints (BASEC)
Ausschlusskriterien
-Use of antibiotics within the last four weeks prior to the start of the study -Significant dietary changes within the last four weeks prior to the start of the study -Presence of clinically relevant diseases or use of clinically relevant medications (BASEC)
Studienstandort
Andere
(BASEC)
Nottwil
(BASEC)
Sponsor
Swiss Paraplegic Research, Nottwil, Switzerland
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Claudio Perret
+41 41 939 66 50
claudio.perret@clutterparaplegie.chSwiss Paraplegic Research
(BASEC)
Allgemeine Auskünfte
Swiss Paraplegic Research, Nottwil
+41419396650
claudio.perret@clutterparaplegie.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
03.03.2025
(BASEC)
ICTRP Studien-ID
NCT06870331 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The effect of probiotic and prebiotic supplementation on gastrointestinal health in individuals with chronic spinal cord injury: a randomized controlled crossover trial (BASEC)
Wissenschaftlicher Titel
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial (ICTRP)
Öffentlicher Titel
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury (ICTRP)
Untersuchte Krankheit(en)
Spinal Cord Injury (ICTRP)
Untersuchte Intervention
Dietary Supplement: ProbioticDietary Supplement: Prebiotic (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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) (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Gastrointestinal symptoms (ICTRP)
Gut microbiome composition;Inflammatory markers;Gastrointestinal transit time (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Jivko Stoyanov, Prof. Dr.Claudio Perret, Prof. Dr., claudio.perret@paraplegie.ch, +41419396650, Swiss Paraplegic Research, Nottwil (ICTRP)
Sekundäre IDs
2024-25 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06870331 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar