Effects of Probiotic and Prebiotic Supplements on Gastrointestinal Health in Individuals with Chronic Spinal Cord Injury
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Gastrointestinal complaints in individuals with chronic spinal cord injury
(BASEC)
-Age 18 years or older -Chronic spinal cord injury (> 1 year) -Gastrointestinal complaints (BASEC)
Critères d'exclusion
-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)
Lieu de l’étude
Autre
(BASEC)
Nottwil
(BASEC)
Sponsor
Swiss Paraplegic Research, Nottwil, Switzerland
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Claudio Perret
+41 41 939 66 50
claudio.perret@clutterparaplegie.chSwiss Paraplegic Research
(BASEC)
Informations générales
Swiss Paraplegic Research, Nottwil
+41419396650
claudio.perret@clutterparaplegie.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
03.03.2025
(BASEC)
Identifiant de l'essai ICTRP
NCT06870331 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
The effect of probiotic and prebiotic supplementation on gastrointestinal health in individuals with chronic spinal cord injury: a randomized controlled crossover trial (BASEC)
Titre académique
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial (ICTRP)
Titre public
The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury (ICTRP)
Maladie en cours d'investigation
Spinal Cord Injury (ICTRP)
Intervention étudiée
Dietary Supplement: ProbioticDietary Supplement: Prebiotic (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Gastrointestinal symptoms (ICTRP)
Gut microbiome composition;Inflammatory markers;Gastrointestinal transit time (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Jivko Stoyanov, Prof. Dr.Claudio Perret, Prof. Dr., claudio.perret@paraplegie.ch, +41419396650, Swiss Paraplegic Research, Nottwil (ICTRP)
ID secondaires
2024-25 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06870331 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible