Probiotic and Prebiotic Supplementation in Elite Athletes With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659408
• Other study ID #: 2020-03
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 29, 2021

Study information

• Verified date: December 2021
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	Luzern

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil	Swiss Paraplegic Research Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Proportion of invited participants who agreed to participate in the trial	At baseline
Primary	Dropout rate	The proportion of randomized participants who did not complete the study protocol	Through study completion, an average of 4 months
Primary	Severe adverse events	The occurrence of severe adverse events (SAEs)	Through study completion, an average of 4 months
Secondary	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
Secondary	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
Secondary	Monitoring of inflammation	C-reactive protein (CRP) from blood samples in mg/L	At 0, 1, 2, 3 months
Secondary	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
Secondary	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
Secondary	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