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Spinal Cord InjuriesNCT04659408

Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury

A study testing Multistrain probiotic preparation and Oat Bran in people with Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Multistrain probiotic preparation and Oat Bran
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSwitzerland
Study dates
1 Mar 2021to 29 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Swiss Paraplegic Centre

    Nottwil, Canton of Lucerne, 6207

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
Multistrain probiotic preparation, Oat Bran
Keywords
probiotic supplementation, prebiotic supplementation
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multistrain probiotic preparationDietary supplement

    Also called BactoSan pro FOS (Mepha, Switzerland)

    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

    Also called Naturaplan Organic Oat Bran (Coop, Switzerland)

    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.

Study groups in NCT04659408
Study groupRoleWhat they receive
Bactosan - oat branExperimentalThis group will receive Bactosan first, followed by oat bran.
Receives: Dietary Supplement: Multistrain probiotic preparation; Dietary Supplement: Oat Bran
Oat bran - BactosanExperimentalThis group will receive oat bran first, followed by Bactosan.
Receives: Dietary Supplement: Multistrain probiotic preparation; Dietary Supplement: Oat Bran

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Proportion of invited participants who agreed to participate in the trial

    Measured: At baseline

  2. Dropout rate

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

    Measured: Through study completion, an average of 4 months

  3. Severe adverse events

    The occurrence of severe adverse events (SAEs)

    Measured: Through study completion, an average of 4 months

Secondary outcomes (6)

  1. 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.

    Measured: At 0, 1, 2, 3 months

  2. 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.

    Measured: At 0, 1, 2, 3 months

  3. Monitoring of inflammation

    C-reactive protein (CRP) from blood samples in mg/L

    Measured: At 0, 1, 2, 3 months

  4. 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).

    Measured: At 0, 1, 2, 3 months

  5. 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.

    Measured: At 0, 1, 2, 3 months

  6. 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).

    Measured: At 0, 1, 2, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start1 Mar 2021
  3. Primary completion29 Oct 2021
  4. Study completion29 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized controlled trial with within-participants crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659408
Sponsor's protocol ID
2020-03
Status last verified
Dec 2021
First submitted
24 Nov 2020
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37322538

  • 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.

    PubMed 35477496

Questions about this trial

What is this clinical trial studying?

A study testing Multistrain probiotic preparation and Oat Bran in people with Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04659408, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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