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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2023-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Signs and Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, prospective, double-blind, placebo-controlled

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

Probiotic formula, 1 stick/day

Group Type EXPERIMENTAL

Experimental product

Intervention Type DIETARY_SUPPLEMENT

Probiotic mix (i3.1) comprising Pediococcus acidilactici KABPTM 021, Lactiplantibacillus plantarum KABPTM 022 and Lactiplantibacillus plantarum KABPTM 023 in a 1:1:1 ratio and with a total concentration of ≥3x10\^9 total colony forming units (CFU) per sachet (stick). Other ingredients are dextrose and maltodextrin as excipients, aroma, flavorings and silicon dioxide. Experimental product will be taken over 4 weeks.

Control group

Placebo formula, 1 stick/day

Group Type PLACEBO_COMPARATOR

Control product

Intervention Type DIETARY_SUPPLEMENT

Placebo product containing dextrose and maltodextrin, aroma, flavorings and silicon dioxide.

Control product will be taken over to weeks

Interventions

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Experimental product

Probiotic mix (i3.1) comprising Pediococcus acidilactici KABPTM 021, Lactiplantibacillus plantarum KABPTM 022 and Lactiplantibacillus plantarum KABPTM 023 in a 1:1:1 ratio and with a total concentration of ≥3x10\^9 total colony forming units (CFU) per sachet (stick). Other ingredients are dextrose and maltodextrin as excipients, aroma, flavorings and silicon dioxide. Experimental product will be taken over 4 weeks.

Intervention Type DIETARY_SUPPLEMENT

Control product

Placebo product containing dextrose and maltodextrin, aroma, flavorings and silicon dioxide.

Control product will be taken over to weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes