Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury

NCT04659408 | Completed

• 1 other identifier: 2020-03
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

probiotic supplementation; prebiotic supplementation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Gastrointestinal problems

  At 0, 1, 2, 3 months

• Stool microbiome characterization

  At 0, 1, 2, 3 months

• Monitoring of inflammation

  At 0, 1, 2, 3 months

• Loss of training days due to injury or illness

  At 0, 1, 2, 3 months

• Food intake during three days

  At 0, 1, 2, 3 months

Study Arms (2)

Bactosan - oat bran

EXPERIMENTAL

This group will receive Bactosan first, followed by oat bran.

Dietary Supplement: Multistrain probiotic preparation; Dietary Supplement: Oat Bran

Oat bran - Bactosan

EXPERIMENTAL

This group will receive oat bran first, followed by Bactosan.

Dietary Supplement: Multistrain probiotic preparation; Dietary Supplement: Oat Bran

Interventions

Multistrain probiotic preparation DIETARY_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.

Also known as: BactoSan pro FOS (Mepha, Switzerland)

Bactosan - oat bran; Oat bran - Bactosan

Oat Bran DIETARY_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.

Also known as: Naturaplan Organic Oat Bran (Coop, Switzerland)

Bactosan - oat bran; Oat bran - Bactosan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (2)

• Hertig-Godeschalk A, Glisic M, Ruettimann B, Valido E, Capossela S, Stoyanov J, Flueck JL. The feasibility of a randomized controlled crossover trial to assess the effect of probiotic and prebiotic supplementation on the health of elite wheelchair athletes. Pilot Feasibility Stud. 2023 Jun 15;9(1):99. doi: 10.1186/s40814-023-01339-6.

  PMID: 37322538 DERIVED

• 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.

  PMID: 35477496 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Joëlle Flück, PhD

  Sports nutrition expert

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with within-participants crossover

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 9, 2020
• Study Start: March 1, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: December 27, 2024

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)