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

NCT06193096 | Completed

• 1 other identifier: AB-ULTRA
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 1

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.

Conditions

Signs and Symptoms

Keywords

Gastrointestinal symptoms; exercise; probiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Digestive symptoms - subscore general digestive discomfort

  Baseline, +24 hours after race

• Digestive symptoms - subscore upper gastrointestinal symptoms

  Baseline, +24 hours after race

• Digestive symptoms - subscore lower gastrointestinal symptoms

  Baseline, +24 hours after race

• Digestive symptoms - subscore other gastrointestinal symptoms

  Baseline, +24 hours after race

• Digestive symptoms - percentage of severity

  Baseline, +24 hours after race

Study Arms (2)

Experimental group

EXPERIMENTAL

Probiotic formula, 1 stick/day

Dietary Supplement: Experimental product

Control group

PLACEBO COMPARATOR

Placebo formula, 1 stick/day

Dietary Supplement: Control product

Interventions

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.

Experimental group

Control product DIETARY_SUPPLEMENT

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

Also known as: Placebo

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (1)

Hospital de Cerdanya

Puigcerdà, Catalonia, 17520, Spain

Location

Related 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.

  PMID: 33136781 BACKGROUND

• 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.

  PMID: 24791919 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.

  PMID: 25024629 BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Salvador Sarrà, PhD

  Hospital de Cerdanya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, prospective, double-blind, placebo-controlled

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: August 15, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)