Impact of a Probiotic-based Formula on Digestive Symptoms and Mood in Ultra Marathon Runners (AB-ULTRA)

AB Biotics

Status

Completed

Conditions

Signs and Symptoms

Treatments

Dietary Supplement: Experimental product

Dietary Supplement: Control product

Study type

Interventional

Funder types

Industry

Identifiers

NCT06193096

AB-ULTRA

Details and patient eligibility

About

Randomized, prospective, double-blind, placebo-controlled study in ultramarathon runners to evaluate the effects of suplementation with i3.1 probiotic formulation on the relief of common digestive symptoms associated to intense physical exercise. Secondary study outcomes aim to evaluate the effect of the probiotic formulation on fatigue, discomfort and muscle pain, as well as anxiety and mood.

Full description

Gastrointestinal symptoms (GIS) are a common feature of intense exercise, especially in ultra-endurance events. The main objective of this study is to evaluate the impact of a 3-strain probiotic formulation comprising Lactiplantibacillus plantarum and Pediococcus acidilactici on digestive symptoms in a maximum of 300 runners registered in an organized ultra-marathon event. A randomized, prospective, double-blind, placebo-controlled study will be conducted. Once recruited, participants will be allocated to recieve either the probiotic or placebo (at a ratio 2:1) for 4 weeks prior to race day. During follow-up, study participants will fulfill several questionnaires at specific time points (baseline, week -3, -2, -1, -24 h previous to the race, as well as 24 h and 7 days after the race). This will be documented through a specifically designed, web-based platform. Digestive symptoms will be evaluated through validated questionnaires: modified from Pfeiffer et al (2012; main outcome) and the Gastrointestinal Symptoms Rating Scale (GSRS). Secondary objectives will comprise anxiety, mood, other symptoms (muscle pain, fatigue, respiratory symptoms), and performance in the ultra-marathon.

Enrollment

277 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age >18 years
Correctly registered in the Salomon Ultra Pirineu 100K® 2023 race
Stable medication planned during the study period
Willing to provide informed consent and follow study procedures
Have signed the consent provided by the organization of the Salomon Ultra Pirineu 100K® 2023 race

Exclusion criteria

Respiratory, gastrointestinal or systemic infection that has caused fever or fatigue in the 15 days prior to the study entry
Having taken probiotic-based supplements or dairy products with probiotics (including "Actimel" or yogurts with "bifidus") daily in the 15 days prior to the study start
Taking oral or parenteral antibiotics in the 15 days prior to the study start
History of gastrointestinal surgery within 6 months prior to the study start
History of cardiovascular event: angina, heart failure, myocardial infarction
Diabetes mellitus type 1 or 2
Pregnancy or lactation, or women planning to conceive during the study period
Chronic gastrointestinal disease: inflammatory bowel disease (Crohn's disease, ulcerative colitis), pancreatitis, short bowel syndrome
Gastrointestinal disease or disorders: inflammatory bowel disease (ulcerative colitis, Crohn's disease), irritable bowel syndrome, chronic diarrhea or constipation
Diagnosis of severe kidney disease (chronic kidney failure) or liver disease (hepatitis, cholestasis, liver failure)