Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury

Swiss Paraplegic Research, Nottwil14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries

Interventions

Multistrain probiotic preparationDIETARY_SUPPLEMENT

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.

Oat BranDIETARY_SUPPLEMENT

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.

Outcomes

Primary Outcomes

Recruitment rate

Proportion of invited participants who agreed to participate in the trial

Time frame: At baseline

Dropout rate

The proportion of randomized participants who did not complete the study protocol

Time frame: Through study completion, an average of 4 months

Severe adverse events

The occurrence of severe adverse events (SAEs)

Time frame: Through study completion, an average of 4 months

Secondary Outcomes

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.