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Completed

NCT Number: NCT06193096

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

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.

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Key information

Conditions

Signs and Symptoms Behavior Motor Activity Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Cerdanya

Puigcerdà, Catalonia, 17520, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Control product

Dietary Supplement

Placebo product containing dextrose and maltodextrin, aroma, flavorings and silicon dioxide.

Control product will be taken over to weeks

Other names: Placebo

Primary outcomes

  1. Digestive symptoms associated to physical exercise

    Time frame: 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 outcomes

  1. Digestive symptoms - subscore general digestive discomfort

    Time frame: 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)

  2. Digestive symptoms - subscore upper gastrointestinal symptoms

    Time frame: 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)

  3. Digestive symptoms - subscore lower gastrointestinal symptoms

    Time frame: 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)

  4. Digestive symptoms - subscore other gastrointestinal symptoms

    Time frame: 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)

  5. Digestive symptoms - percentage of severity

    Time frame: 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)

  6. Digestive symptoms measured with GSRS

    Time frame: 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

  7. Competitive Anxiety before race

    Time frame: -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).

  8. Race time

    Time frame: +24 hours after the race

    Race time at the end of the ultra in participants who finalize the race

  9. Abandonment during the race

    Time frame: +24 hours after the race

    Percentage of abandonment during the race for any reason (including gastrointestinal problems)

  10. Stool consistency

    Time frame: -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

  11. Mood States

    Time frame: +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).

  12. Muscle pain

    Time frame: -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).

  13. Fatigue

    Time frame: -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).

  14. Headache

    Time frame: -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).

  15. Fever

    Time frame: Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race

    Number of fever episodes in a specified period of time

  16. Respiratory symptoms

    Time frame: Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race

    Number of days with respiratory symptoms

  17. Sleep quality

    Time frame: 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).

  18. Adverse events

    Time frame: Baseline, week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race

    Registration of adverse events throughout all study period

Sponsors and collaborators

Lead sponsor

AB Biotics, SA

Industry

Registry information

Official study title

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

Acronym: AB-ULTRA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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