Probiotic and Prebiotic Supplementation in Elite Athletes With Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Comfort in Elite Athletes With Spinal Cord Injury: A Pilot Study

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Dietary Supplement: Multistrain probiotic preparation
* Dietary Supplement: Oat Bran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized controlled trial with within-participants crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bactosan - oat bran<br>This group will receive Bactosan first, followed by oat bran. | Dietary Supplement: Multistrain probiotic preparation<br>* One sachet daily, containing 3 grams of the freeze-dried multispecies probiotic Bactosan for a period of four weeks. One sachet will be mixed with 50-100 ml water and taken daily before breakfast or dinner. Bactosan contains the following eight bacterial strains: Bifidobacterium lactis W51, Bifidobacterium lactis W52, Enterococcus faecium W54, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Lactobacillus plantarum W21, Lactobacillus salivarius W24 and Lactococcus lactis W19, with a total viable cell count of 1 × 109 cfu/gram, and therefore 3 × 109 cfu/daily dose.<br>* Other names: BactoSan pro FOS (Mepha, Switzerland);Dietary Supplement: Oat Bran<br>* 5 grams (one teaspoon) daily of the oat bran together with a meal of preference. The oat bran can be added to the usual breakfast cereal, yoghurt, pancakes, juice, milk, salad sauce or in an omelette.<br>* Other names: Naturaplan Organic Oat Bran (Coop, Switzerland);|
| Experimental: Oat bran - Bactosan<br>This group will receive oat bran first, followed by Bactosan. | Dietary Supplement: Multistrain probiotic preparation<br>* One sachet daily, containing 3 grams of the freeze-dried multispecies probiotic Bactosan for a period of four weeks. One sachet will be mixed with 50-100 ml water and taken daily before breakfast or dinner. Bactosan contains the following eight bacterial strains: Bifidobacterium lactis W51, Bifidobacterium lactis W52, Enterococcus faecium W54, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Lactobacillus plantarum W21, Lactobacillus salivarius W24 and Lactococcus lactis W19, with a total viable cell count of 1 × 109 cfu/gram, and therefore 3 × 109 cfu/daily dose.<br>* Other names: BactoSan pro FOS (Mepha, Switzerland);Dietary Supplement: Oat Bran<br>* 5 grams (one teaspoon) daily of the oat bran together with a meal of preference. The oat bran can be added to the usual breakfast cereal, yoghurt, pancakes, juice, milk, salad sauce or in an omelette.<br>* Other names: Naturaplan Organic Oat Bran (Coop, Switzerland);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Proportion of invited participants who agreed to participate in the trial | At baseline | 
| Dropout rate | The proportion of randomized participants who did not complete the study protocol | Through study completion, an average of 4 months | 
| Severe adverse events | The occurrence of severe adverse events (SAEs) | Through study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal problems | 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. | At 0, 1, 2, 3 months | 
| Stool microbiome characterization | 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. | At 0, 1, 2, 3 months | 
| Monitoring of inflammation | C-reactive protein (CRP) from blood samples in mg/L | At 0, 1, 2, 3 months | 
| Loss of training days due to injury or illness | Assessed using the Oslo Sports Trauma Research Centre (OSTRC) Overuse Injury Questionnaire, which consists of several multiple choice and open questions (no scale). | At 0, 1, 2, 3 months | 
| Food intake during three days | 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. | At 0, 1, 2, 3 months | 
| Recording of leisure time activity | Assessed using the Leisure Time Physical Activity Questionnaire (LTPA-Q), which records number of days and minutes of physical activity (no scale). | At 0, 1, 2, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic supplementation, prebiotic supplementation