Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury
- Conditions
- Spinal Cord Injuries
- Interventions
- Dietary Supplement: Multistrain probiotic preparationDietary Supplement: Oat Bran
- Registration Number
- NCT04659408
- Lead Sponsor
- Swiss Paraplegic Research, Nottwil
- Brief Summary
The main objective of this pilot study is to obtain information, which will be used for the design of a main randomized controlled trial (RCT) with a larger size based on feasibility, validity and sample size estimation as well as the potential effects of pre- and probiotic intake on intestinal microbiota. A larger trial will then be designed to test the hypothesis that adding probiotics or prebiotics may improve gut microbiome composition, gastrointestinal symptoms as well as cardiometabolic health indices in mid-term and possibly lead to improved sports performance over a longer-term period in athletes with a Spinal Cord Injury.
- Detailed Description
In this pilot crossover randomized controlled trial, twenty (N = 20) para-athletes will participate in an intervention consisting of a four-week intake of probiotic, using the commercially available multistrain probiotic preparation "BactoSan pro FOS" from Mepha (Basel, Switzerland), followed by a four-week wash-out period, and a four-week prebiotic intervention using "Naturaplan Bio Oat Bran" (Coop, Switzerland). Total duration of the study will be 16 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- athletes with a spinal cord injury shortlisted as potential participants for major international events, such as the Paralympic Games 2021 in Tokyo and World Championship qualification
- Chronic inflammatory bowel diseases (i.e. ulcerative colitis, Crohn's disease)
- Taking antibiotics and/or other medication to alleviate gastrointestinal complaints at recruitment time point
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oat bran - Bactosan Multistrain probiotic preparation This group will receive oat bran first, followed by Bactosan. Bactosan - oat bran Multistrain probiotic preparation This group will receive Bactosan first, followed by oat bran. Oat bran - Bactosan Oat Bran This group will receive oat bran first, followed by Bactosan. Bactosan - oat bran Oat Bran This group will receive Bactosan first, followed by oat bran.
- Primary Outcome Measures
Name Time Method Severe adverse events Through study completion, an average of 4 months The occurrence of severe adverse events (SAEs)
Dropout rate Through study completion, an average of 4 months The proportion of randomized participants who did not complete the study protocol
Recruitment rate At baseline Proportion of invited participants who agreed to participate in the trial
- Secondary Outcome Measures
Name Time Method Stool microbiome characterization At 0, 1, 2, 3 months Stool probes will be sampled by the participants at home and send to the study center. The "What's in my Pot?" (WIMP) workflow (Oxford Nanopore Technologies) will be used to classify and identify species in real time, generating a graphical WIMP report of the sample composition and the most reliable placement in the taxonomy tree, assigning a score to each taxonomic placement.
Monitoring of inflammation At 0, 1, 2, 3 months C-reactive protein (CRP) from blood samples in mg/L
Loss of training days due to injury or illness At 0, 1, 2, 3 months Assessed using the Oslo Sports Trauma Research Centre (OSTRC) Overuse Injury Questionnaire, which consists of several multiple choice and open questions (no scale).
Gastrointestinal problems At 0, 1, 2, 3 months Assessed using the Gastrointestinal Quality of Life Index (GIQLI) of Eypasch, using a 5-point scale (0-4) with total range 0-144 and higher scores indicating better outcomes.
Food intake during three days At 0, 1, 2, 3 months Self-reported intake (content and quantity) of food on a data sheet, including photo's. Calculations of the nutritional quality and quantity of consumed foods, drinks and nutritional supplements will be performed using PRODI® Swiss, a computer program for nutritional counselling and nutritional therapy.
Recording of leisure time activity At 0, 1, 2, 3 months Assessed using the Leisure Time Physical Activity Questionnaire (LTPA-Q), which records number of days and minutes of physical activity (no scale).
Trial Locations
- Locations (1)
Swiss Paraplegic Centre
🇨🇭Nottwil, Luzern, Switzerland