The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Comfort in Elite Athletes with Spinal Cord Injury: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Swiss Paraplegic Research, Nottwil
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Severe adverse events
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Severe adverse events
Time Frame: Through study completion, an average of 4 months
The occurrence of severe adverse events (SAEs)
Recruitment rate
Time Frame: At baseline
Proportion of invited participants who agreed to participate in the trial
Dropout rate
Time Frame: Through study completion, an average of 4 months
The proportion of randomized participants who did not complete the study protocol
Secondary Outcomes
- Monitoring of inflammation(At 0, 1, 2, 3 months)
- Stool microbiome characterization(At 0, 1, 2, 3 months)
- Loss of training days due to injury or illness(At 0, 1, 2, 3 months)
- Gastrointestinal problems(At 0, 1, 2, 3 months)
- Food intake during three days(At 0, 1, 2, 3 months)
- Recording of leisure time activity(At 0, 1, 2, 3 months)