Clinical trial NCT06193096: Impact of a Probiotic-based Formula on Digestive Symptoms and Mood in Ultra Marathon Runners
Official title: Evaluation of the Impact of a Probiotic-based Formula on Digestive Symptoms, General Symptoms and Mood in Ultra Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Signs and Symptoms
Keywords: Gastrointestinal symptoms
exercise
probiotics
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, prospective, double-blind, placebo-controlled
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Digestive symptoms associated to physical exercise
timeFrame: Baseline, +24 hours after race
Secondary outcomes:
measure: Digestive symptoms - subscore general digestive discomfort
timeFrame: Baseline, +24 hours after race
measure: Digestive symptoms - subscore upper gastrointestinal symptoms
timeFrame: Baseline, +24 hours after race
measure: Digestive symptoms - subscore lower gastrointestinal symptoms
timeFrame: Baseline, +24 hours after race
measure: Digestive symptoms - subscore other gastrointestinal symptoms
timeFrame: Baseline, +24 hours after race
measure: Digestive symptoms - percentage of severity
timeFrame: Baseline, +24 hours after race
measure: Digestive symptoms measured with GSRS
timeFrame: week -3, -2 and -1 previous race,-24 hours before race, +7 days after race
measure: Competitive Anxiety before race
timeFrame: -24 hours (before race)
measure: Race time
timeFrame: +24 hours after the race
measure: Abandonment during the race
timeFrame: +24 hours after the race
measure: Stool consistency
timeFrame: -24 hours before race, +24 hours after race
measure: Mood States
timeFrame: +24 hours, +7 days (after race)
measure: Muscle pain
timeFrame: -24 hours before race, +24 hours after race, +7 days
measure: Fatigue
timeFrame: -24 hours before race, +24 hours after race, +7 days
measure: Headache
timeFrame: -24 hours before race, +24 hours after race, +7 days
measure: Fever
timeFrame: Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race
measure: Respiratory symptoms
timeFrame: Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race
measure: Sleep quality
timeFrame: Baseline, -24 hours before race, +7 days after race
measure: Adverse events
timeFrame: Baseline, week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race
Other outcomes:
Locations:
city: Puigcerdà
country: Spain
facility: Hospital de Cerdanya
state: Catalonia
Study officials:
affiliation: Hospital de Cerdanya
name: Salvador Sarrà, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cano-Contreras AD, Minero Alfaro IJ, Medina Lopez VM, Amieva Balmori M, Remes Troche JM, Espadaler Mazo J, Perez Lopez N. Efficacy of i3.1 Probiotic on Improvement of Lactose Intolerance Symptoms: A Randomized, Placebo-controlled Clinical Trial. J Clin Gastroenterol. 2022 Feb 1;56(2):141-147. doi: 10.1097/MCG.0000000000001456.
citation: de Oliveira EP, Burini RC, Jeukendrup A. Gastrointestinal complaints during exercise: prevalence, etiology, and nutritional recommendations. Sports Med. 2014 May;44 Suppl 1(Suppl 1):S79-85. doi: 10.1007/s40279-014-0153-2.
citation: Lorenzo-Zuniga V, Llop E, Suarez C, Alvarez B, Abreu L, Espadaler J, Serra J. I.31, a new combination of probiotics, improves irritable bowel syndrome-related quality of life. World J Gastroenterol. 2014 Jul 14;20(26):8709-16. doi: 10.3748/wjg.v20.i26.8709.