Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury

The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Comfort in Elite Athletes with Spinal Cord Injury: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Dietary supplement: Multistrain probiotic preparation; Dietary supplement: Oat Bran

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Luzern
    • Nottwil, Luzern, Switzerland, 6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bactosan - oat bran; This group will receive Bactosan first, followed by oat bran.	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.; Other Names: BactoSan pro FOS (Mepha, Switzerland); 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.; Other Names: Naturaplan Organic Oat Bran (Coop, Switzerland)
Experimental: Oat bran - Bactosan; This group will receive oat bran first, followed by Bactosan.	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.; Other Names: BactoSan pro FOS (Mepha, Switzerland); 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.; Other Names: Naturaplan Organic Oat Bran (Coop, Switzerland)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Collaborators: Swiss Paraplegic Research Nottwil
• Investigators: Principal Investigator: Joëlle Flück, PhD, Sports nutrition expert

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: probiotic supplementation; prebiotic supplementation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 2020-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No