Signs and Symptoms Clinical Trial
— AB-ULTRAOfficial title:
Evaluation of the Impact of a Probiotic-based Formula on Digestive Symptoms, General Symptoms and Mood in Ultra Runners
Verified date | January 2024 |
Source | AB Biotics, SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 277 |
Est. completion date | October 10, 2023 |
Est. primary completion date | October 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de Cerdanya | Puigcerdà | Catalonia |
Lead Sponsor | Collaborator |
---|---|
AB Biotics, SA |
Spain,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | Race time | Race time at the end of the ultra in participants who finalize the race | +24 hours after the race | |
Secondary | Abandonment during the race | Percentage of abandonment during the race for any reason (including gastrointestinal problems) | +24 hours after the race | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Respiratory symptoms | Number of days with respiratory symptoms | Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race | |
Secondary | 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 | |
Secondary | 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 |
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