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

Signs and Symptoms Clinical Trial

— AB-ULTRA  

Official title:

Evaluation of the Impact of a Probiotic-based Formula on Digestive Symptoms, General Symptoms and Mood in Ultra Runners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06193096
• Other study ID #: AB-ULTRA
• Status: Completed
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: October 10, 2023

Study information

• Verified date: January 2024
• Source: AB Biotics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Signs and Symptoms

Intervention

Dietary Supplement:
• 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.
• Control product
Placebo product containing dextrose and maltodextrin, aroma, flavorings and silicon dioxide. Control product will be taken over to weeks

Locations

Country	Name	City	State
Spain	Hospital de Cerdanya	Puigcerdà	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
AB Biotics, SA

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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

Outcome

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