Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06193096
Other study ID # AB-ULTRA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Completed NCT00378989 - The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability N/A
Withdrawn NCT02689817 - Monitoring Physiologic Data in the Development of Pressure Ulcers N/A
Completed NCT02826408 - Effect of Proton Pump Inhibitors on Palpitations N/A
Recruiting NCT01708668 - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia N/A
Recruiting NCT02913365 - Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis N/A
Completed NCT00784108 - Optimizing Photodynamic Therapy of Cutaneous Neoplastic Diseases Via Structured Illumination and Real-time Dosimetry. Phase 1
Completed NCT00230932 - Help Veterans Experience Less Pain Study (HELP-Vets) N/A
Recruiting NCT00173706 - Evaluation of the Effects of L-Carnitine Injection in Patients Undergoing Hemodialysis Phase 4
Terminated NCT01192594 - Milestones of Adjustment Post-Psychosis Phase 3
Withdrawn NCT01277276 - Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
Completed NCT04606199 - Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity N/A
Withdrawn NCT01814293 - Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs) N/A
Completed NCT01483703 - Noninvasive Optical Measurement of Critical Care Neonates
Completed NCT04260035 - The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) in Episodic Migraine Patients N/A
Completed NCT01340027 - A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder Phase 2
Completed NCT03471923 - Non-Motor Features of Cervical Dystonia (CD)
Completed NCT03544268 - Academic-Industrial Partnership for Translation of Acoustic Angiography Phase 4
Completed NCT01954199 - The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain N/A
Recruiting NCT01551238 - Energy Expenditure, Sleep and Macronutrients N/A