Status:
COMPLETED
Impact of a Probiotic-based Formula on Digestive Symptoms and Mood in Ultra Marathon Runners
Lead Sponsor:
AB Biotics, SA
Conditions:
Signs and Symptoms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 sym...
Detailed 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 formu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT06193096
Start Date
August 15 2023
End Date
October 10 2023
Last Update
September 19 2024
Active Locations (1)
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1
Hospital de Cerdanya
Puigcerdà, Catalonia, Spain, 17520