Effects of Probiotic and Prebiotic Supplements on Gastrointestinal Health in Individuals with Chronic Spinal Cord Injury
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Gastrointestinal complaints in individuals with chronic spinal cord injury
(BASEC)
-Age 18 years or older -Chronic spinal cord injury (> 1 year) -Gastrointestinal complaints (BASEC)
Criteri di esclusione
-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)
Luogo dello studio
Altro
(BASEC)
Nottwil
(BASEC)
Sponsor
Swiss Paraplegic Research, Nottwil, Switzerland
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Claudio Perret
+41 41 939 66 50
claudio.perret@clutterparaplegie.chSwiss Paraplegic Research
(BASEC)
Informazioni generali
Swiss Paraplegic Research, Nottwil
+41419396650
claudio.perret@clutterparaplegie.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
03.03.2025
(BASEC)
ID di studio ICTRP
NCT06870331 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
The effect of probiotic and prebiotic supplementation on gastrointestinal health in individuals with chronic spinal cord injury: a randomized controlled crossover trial (BASEC)
Titolo accademico
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial (ICTRP)
Titolo pubblico
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury (ICTRP)
Malattie studiate
Spinal Cord Injury (ICTRP)
Intervento studiato
Dietary Supplement: ProbioticDietary Supplement: Prebiotic (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Gastrointestinal symptoms (ICTRP)
Gut microbiome composition;Inflammatory markers;Gastrointestinal transit time (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Jivko Stoyanov, Prof. Dr.Claudio Perret, Prof. Dr., claudio.perret@paraplegie.ch, +41419396650, Swiss Paraplegic Research, Nottwil (ICTRP)
ID secondari
2024-25 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06870331 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile