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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Probiotic formula, 1 stick/day |
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| Control group | Placebo Comparator | Placebo formula, 1 stick/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive symptoms associated to physical exercise | 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) | Baseline, +24 hours after race |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive symptoms - subscore general digestive discomfort | 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) | Baseline, +24 hours after race |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salvador Sarrà , PhD | Hospital de Cerdanya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Cerdanya | Puigcerdà | Catalonia | 17520 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33136781 | Background | 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. | |
| 24791919 |
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| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Randomized, prospective, double-blind, placebo-controlled
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| Control product | Dietary Supplement | Placebo product containing dextrose and maltodextrin, aroma, flavorings and silicon dioxide. Control product will be taken over to weeks |
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| Digestive symptoms - subscore upper gastrointestinal symptoms |
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) |
| Baseline, +24 hours after race |
| Digestive symptoms - subscore lower gastrointestinal symptoms | 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) | Baseline, +24 hours after race |
| Digestive symptoms - subscore other gastrointestinal symptoms | 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) | Baseline, +24 hours after race |
| Digestive symptoms - percentage of severity | 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) | Baseline, +24 hours after race |
| Digestive symptoms measured with GSRS | 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 | week -3, -2 and -1 previous race,-24 hours before race, +7 days after race |
| Competitive Anxiety before race | Score of the Competitive State Anxiety Inventory-2R (CSAI-2R) questionnaire. The scoring ranges from 0 (nothing) to 4 (a lot). | -24 hours (before race) |
| Race time | Race time at the end of the ultra in participants who finalize the race | +24 hours after the race |
| Abandonment during the race | Percentage of abandonment during the race for any reason (including gastrointestinal problems) | +24 hours after the race |
| Stool consistency | 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 | -24 hours before race, +24 hours after race |
| Mood States | 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). | +24 hours, +7 days (after race) |
| Muscle pain | Muscle pain, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely). | -24 hours before race, +24 hours after race, +7 days |
| Fatigue | Fatigue, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely). | -24 hours before race, +24 hours after race, +7 days |
| Headache | Headache, evaluated through Visual Analogue Scale (VAS) scale. The scoring ranges from 0 (not at all) to 10 (extremely). | -24 hours before race, +24 hours after race, +7 days |
| Fever | Number of fever episodes in a specified period of time | Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race |
| Respiratory symptoms | Number of days with respiratory symptoms | Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race |
| Sleep quality | Sleep quality, evaluated through 10-point scale. The scoring ranges from 0 (the worst quality) to 10 (best quality). | Baseline, -24 hours before race, +7 days after race |
| Adverse events | Registration of adverse events throughout all study period | Baseline, week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race |
| 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. |
| 25024629 | Background | 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. |
| D008722 | Methods |