Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06193096
Study type Interventional
Source AB Biotics, SA
Contact
Status Completed
Phase N/A
Start date August 15, 2023
Completion date October 10, 2023

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Withdrawn NCT02689817 - Monitoring Physiologic Data in the Development of Pressure Ulcers N/A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