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Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury

NCT04659408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries

Interventions

DIETARY_SUPPLEMENT

Multistrain probiotic preparation

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.

DIETARY_SUPPLEMENT

Oat Bran

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.

Sponsors & Collaborators

  • Swiss Paraplegic Research, Nottwil

    lead NETWORK

Principal Investigators

  • Joëlle Flück, PhD · Sports nutrition expert

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-10-29
Completion
2021-10-29

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659408 on ClinicalTrials.gov