Signs and Symptoms
Conditions
Keywords
Gastrointestinal symptoms, exercise, probiotics
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.
Interventions
DIETARY_SUPPLEMENTExperimental 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.
DIETARY_SUPPLEMENTControl product
Placebo product containing dextrose and maltodextrin, aroma, flavorings and silicon dioxide. Control product will be taken over to weeks
Sponsors
AB Biotics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, prospective, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digestive symptoms associated to physical exercise | Baseline, +24 hours after race | Digestive tract digestive symptoms score measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Digestive symptoms - subscore upper gastrointestinal symptoms | Baseline, +24 hours after race | Evaluation of upper gastrointestinal symptoms subscore measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms) |
| Digestive symptoms - subscore lower gastrointestinal symptoms | Baseline, +24 hours after race | Evaluation of lower gastrointestinal symptoms subscore measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms) |
| Digestive symptoms - subscore other gastrointestinal symptoms | Baseline, +24 hours after race | Evaluation of other gastrointestinal symptoms (nausea, dizziness, stitch) subscore measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms) |
| Digestive symptoms - percentage of severity | Baseline, +24 hours after race | Percentage of participants with severe symptoms (value \>4) measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms) |
| Digestive symptoms measured with GSRS | week -3, -2 and -1 previous race,-24 hours before race, +7 days after race | Evaluation of digestive symptoms measured with Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. The GSRS has a 7-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms |
| Competitive Anxiety before race | -24 hours (before race) | Score of the Competitive State Anxiety Inventory-2R (CSAI-2R) questionnaire. The scoring ranges from 0 (nothing) to 4 (a lot). |
| Race time | +24 hours after the race | Race time at the end of the ultra in participants who finalize the race |
| Abandonment during the race | +24 hours after the race | Percentage of abandonment during the race for any reason (including gastrointestinal problems) |
| Digestive symptoms - subscore general digestive discomfort | Baseline, +24 hours after race | Evaluation of general digestive discomfort measured with modified Pfeiffer questionnaire. Scoring ranges from 0 to 10 according to the intensity of the symptom (0-2 non-existent or mild symptoms; 3-7 moderate symptoms; 8-10 severe symptoms) |
| Mood States | +24 hours, +7 days (after race) | Score of the total Profile of Mood States (POMS) and the associated factors: Tension, Depression, Anger, Vigor, and Fatigue, evaluated using a visual analogue scale (VAS). The scoring ranges from 0 (not at all) to 4 (extremely). |
| Muscle pain | -24 hours before race, +24 hours after race, +7 days | Muscle pain, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely). |
| Fatigue | -24 hours before race, +24 hours after race, +7 days | Fatigue, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely). |
| Headache | -24 hours before race, +24 hours after race, +7 days | Headache, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely). |
| Fever | Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race | Number of fever episodes in a specified period of time |
| Respiratory symptoms | Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race | Number of days with respiratory symptoms |
| Sleep quality | Baseline, -24 hours before race, +7 days after race | Sleep quality, evaluated through 10-point scale. The scoring ranges from 0 (the worst quality) to 10 (best quality). |
| Adverse events | Baseline, week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race | Registration of adverse events throughout all study period |
| Stool consistency | -24 hours before race, +24 hours after race | Evaluation of stool consistency measured through Bristol scale (score from 1 to 7). Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea |
Countries
Spain
Outcome results
None listed