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

September 16, 2024 updated by: AB Biotics, SA

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
277

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Puigcerdà, Catalonia, Spain, 17520
        • Hospital de Cerdanya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Probiotic formula, 1 stick/day
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.
Placebo Comparator: Control group
Placebo formula, 1 stick/day
Dietary supplement: Control product

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

Control product will be taken over to weeks

Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, +24 hours after race

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, +24 hours after race
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)
Baseline, +24 hours after race
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)
Baseline, +24 hours after race
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)
Baseline, +24 hours after race
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)
Baseline, +24 hours after race
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
week -3, -2 and -1 previous race,-24 hours before race, +7 days after race
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).
-24 hours (before race)
Race time
Time Frame: +24 hours after the race
Race time at the end of the ultra in participants who finalize the race
+24 hours after the race
Abandonment during the race
Time Frame: +24 hours after the race
Percentage of abandonment during the race for any reason (including gastrointestinal problems)
+24 hours after the race
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
-24 hours before race, +24 hours after race
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).
+24 hours, +7 days (after race)
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).
-24 hours before race, +24 hours after race, +7 days
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).
-24 hours before race, +24 hours after race, +7 days
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).
-24 hours before race, +24 hours after race, +7 days
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
Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race
Respiratory symptoms
Time Frame: Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race
Number of days with respiratory symptoms
Week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race
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).
Baseline, -24 hours before race, +7 days after race
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
Baseline, week -3, -2, -1, -24 hours before race, +24 hours, +7 days after race

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AB Biotics, SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Salvador Sarrà, PhD, Hospital de Cerdanya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AB-ULTRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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