Probiotic and Prebiotic Supplementation in Elite Athletes with Spinal Cord Injury

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Spinal Cord Injuries

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

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT04659408

2020-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Bactosan - oat bran

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Bran

Dietary Supplement: Multistrain probiotic preparation

Oat bran - Bactosan

Experimental group

Description:

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

Treatment:

Dietary Supplement: Oat Bran

Dietary Supplement: Multistrain probiotic preparation