Clinical trial NCT04659408: Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury
Official title: The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Comfort in Elite Athletes with Spinal Cord Injury: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: probiotic supplementation
prebiotic supplementation
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2020-12-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial with within-participants crossover
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Recruitment rate
timeFrame: At baseline
measure: Dropout rate
timeFrame: Through study completion, an average of 4 months
measure: Severe adverse events
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
measure: Gastrointestinal problems
timeFrame: At 0, 1, 2, 3 months
measure: Stool microbiome characterization
timeFrame: At 0, 1, 2, 3 months
measure: Monitoring of inflammation
timeFrame: At 0, 1, 2, 3 months
measure: Loss of training days due to injury or illness
timeFrame: At 0, 1, 2, 3 months
measure: Food intake during three days
timeFrame: At 0, 1, 2, 3 months
measure: Recording of leisure time activity
timeFrame: At 0, 1, 2, 3 months
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Luzern
Study officials:
affiliation: Sports nutrition expert
name: Joëlle Flück, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glisic M, Flueck JL, Ruettimann B, Hertig-Godeschalk A, Valido E, Bertolo A, Stucki G, Stoyanov J. The feasibility of a crossover, randomized controlled trial design to assess the effect of probiotics and prebiotics on health of elite Swiss para-athletes: a study protocol. Pilot Feasibility Stud. 2022 Apr 27;8(1):94. doi: 10.1186/s40814-022-01048-6.