Ultra-endurance Athletes With Gastrointestinal SymptomsNCT04779281
Effects of Probiotics and Nutritional Status on Exercise-Induced Symptoms, and Endurance Performance in Ultra-Endurance Athletes
A study testing Oral Rehydration Salts supplemented with L. Rhamnosus GG and Oral Rehydration Salts only in people with Ultra-endurance Athletes With Gastrointestinal Symptoms, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Ultra-endurance athletes have been commonly endured extreme conditions during races and training sessions, resulting in exercise-associated clinical symptoms, including gastrointestinal symptoms, dehydration, and elevated oxidative stress. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Ultra-endurance Athletes With Gastrointestinal Symptoms
- What is being tested?
- Oral Rehydration Salts supplemented with L. Rhamnosus GG and Oral Rehydration Salts only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who train at least 15 h per week,
- Participants who do not have any metabolic disease,
- Have had at least one gastrointestinal symptom determined by using a Gastrointestinal Symptoms Rating Scale and Bristol Stool Chart Form Scale,
- Being a non-smoker,
- Have participated in at least one ultra-endurance race/event (lasts > 4 hr),
- Taking no vitamins, minerals, dietary supplements, antibiotics, and any medication at least during the three months before the study,
- (For women) participants with a regular menstrual cycle of physiological length (24-35 days)
Who cannot join
- Regular tobacco use
- Inability to adhere to any of the study protocol requirements (i.e. alcohol, caffeine consumption, diet control)
- Having consumed any supplements and/or medicines for the preceding 3 months period.
- (For women) participants in menopause or using oral contraceptives
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Centre of Athlete Training and Health Research
Ankara, 068290
About this study
Official title: Effects of Nutritional Status and Probiotics on Exercise-Related Clinical and Gastrointestinal Symptoms and Endurance Performance in Ultra-Endurance Athletes
Ultra-endurance athletes have been commonly endured extreme conditions during races and training sessions, resulting in exercise-associated clinical symptoms, including gastrointestinal symptoms, dehydration, and elevated oxidative stress. Although these alterations adversely affect sports performance and well-being, there is no certain treatment or consensus on alleviating the exercise-associated clinical symptoms in ultra-endurance athletes. The objective of this study is to determine the effects of oral rehydration salts supplemented with Lactobacillus Rhamnosus GG on exercise-induced gastrointestinal problems, dehydration and oxidative stress in ultra-endurance athletes. Additionally, we aimed to assess the exercise-induced alterations in oxidative stress determined by applying an acute strenuous exercise protocol ((a cycle ergometer (45 min at 65%VO2max) immediately followed by a treadmill test (75% VO2max to exhaustion)) before and after the supplementation period.
- Being tested
- Oral Rehydration Salts supplemented with L. Rhamnosus GG, Oral Rehydration Salts only
- Keywords
- signs and symptoms, digestive, Probiotics, Oral rehydration therapy, Gastrointestinal Microbiome
- Medical subject headings
- Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Rehydration Salts supplemented with L. Rhamnosus GGDietary supplement
A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides
Oral Rehydration Salts onlyDietary supplement
A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Oral Rehydration Salts supplemented with L. Rhamnosus GG | Experimental | a supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides Receives: Dietary Supplement: Oral Rehydration Salts only |
| Oral Rehydration Salts only | Experimental | A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose Receives: Dietary Supplement: Oral Rehydration Salts supplemented with L. Rhamnosus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the gut microbiome after a 4-week supplementation period
- To assess the profile of gut flora (% abundance of various bacterial phyla, families, genera and species) at baseline and after supplementation in ultra-endurance athletes, using a 16S ribosomal RNA sequencing
Measured: Change from Baseline Gut Microbiome at 4 weeks
Secondary outcomes (1)
Changes in blood markers of exercise-associated oxidative stress (8-isoprostaglandin 2Fa, Total Antioxidant Capacity, and Total Oxidant Capacity in plasma)
- Blood samples were collected pre-and post-exercise applied before and after supplementation to evaluate the change in exercise-induced oxidative stress in plasma. Plasma concentrations of 8-isoprostaglandin 2Fa, Total Antioxidant Capacity, and Total Oxidant Capacity were analysed using ELISA kits.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Sep 2018
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ultra-endurance Athletes With Gastrointestinal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ultra-endurance athletes with at least one gastrointestinal symptoms will be administered oral rehydration salts supplemented with L. Rhamnosus GG or oral rehydration salts only for 4 weeks
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Devrim Lanpir, Istanbul Medeniyet University
- Investigators
- Tuğba Kocahan, MD, Study director, Centre of Athlete Training and Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779281
- Sponsor's protocol ID
- KA-180011
- Other IDs
- 18-AKD-89
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krabak BJ, Lipman GS, Waite BL, Rundell SD. Exercise-Associated Hyponatremia, Hypernatremia, and Hydration Status in Multistage Ultramarathons. Wilderness Environ Med. 2017 Dec;28(4):291-298. doi: 10.1016/j.wem.2017.05.008. Epub 2017 Aug 7.
PubMed 28781178Nocella C, Cammisotto V, Pigozzi F, Borrione P, Fossati C, D'Amico A, Cangemi R, Peruzzi M, Gobbi G, Ettorre E, Frati G, Cavarretta E, Carnevale R; SMiLe Group. Impairment between Oxidant and Antioxidant Systems: Short- and Long-term Implications for Athletes' Health. Nutrients. 2019 Jun 15;11(6):1353. doi: 10.3390/nu11061353.
PubMed 31208096Pyne DB. Exercise-induced muscle damage and inflammation: a review. Aust J Sci Med Sport. 1994 Sep-Dec;26(3-4):49-58.
PubMed 8665277Lopez AA, Preziosi JP, Chateau P, Auguste P, Plique O. [Digestive disorders and self medication observed during a competition in endurance athletes. Prospective epidemiological study during a championship of triathlon]. Gastroenterol Clin Biol. 1994;18(4):317-22. French.
PubMed 7958646Maughan RJ, Shirreffs SM. Sports Beverages for Optimizing Physical Performance. In: Wilson T., Temple N. (eds) Beverage Impacts on Health and Nutrition. Nutrition and Health. Humana Press, Cham. 2016.
Mach N, Fuster-Botella D. Endurance exercise and gut microbiota: A review. J Sport Health Sci. 2017 Jun;6(2):179-197. doi: 10.1016/j.jshs.2016.05.001. Epub 2016 May 10.
PubMed 30356594Hoffman MD, Stellingwerff T, Costa RJS. Considerations for ultra-endurance activities: part 2 - hydration. Res Sports Med. 2019 Apr-Jun;27(2):182-194. doi: 10.1080/15438627.2018.1502189. Epub 2018 Jul 28.
PubMed 30056755Hooper LV, Gordon JI. Commensal host-bacterial relationships in the gut. Science. 2001 May 11;292(5519):1115-8. doi: 10.1126/science.1058709.
PubMed 11352068Kekkonen RA, Vasankari TJ, Vuorimaa T, Haahtela T, Julkunen I, Korpela R. The effect of probiotics on respiratory infections and gastrointestinal symptoms during training in marathon runners. Int J Sport Nutr Exerc Metab. 2007 Aug;17(4):352-63. doi: 10.1123/ijsnem.17.4.352.
PubMed 17962710Martarelli D, Verdenelli MC, Scuri S, Cocchioni M, Silvi S, Cecchini C, Pompei P. Effect of a probiotic intake on oxidant and antioxidant parameters in plasma of athletes during intense exercise training. Curr Microbiol. 2011 Jun;62(6):1689-96. doi: 10.1007/s00284-011-9915-3. Epub 2011 Mar 12.
PubMed 21400082
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Status and Probiotics on Exercise-Related Clinical and Gastrointestinal Symptoms and Endurance Performance in Ultra-Endurance Athletes
- ClinicalTrials.gov ID
- NCT04779281
- Acronym / sponsor ID
- KA-180011
- Keywords
- signs and symptoms, digestive, Probiotics, Oral rehydration therapy, Gastrointestinal Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ultra-endurance athletes have been commonly endured extreme conditions during races and training sessions, resulting in exercise-associated clinical symptoms, including gastrointestinal symptoms, dehydration, and elevated oxidative stress. Although these alterations adversely affect sports performance and well-being, there is no certain treatment or consensus on alleviating the exercise-associated clinical symptoms in ultra-endurance athletes. The objective of this study is to determine the effects of oral rehydration salts supplemented with Lactobacillus Rhamnosus GG on exercise-induced gastrointestinal problems, dehydration and oxidative stress in ultra-endurance athletes. Additionally, we aimed to assess the exercise-induced alterations in oxidative stress determined by applying an acute strenuous exercise protocol ((a cycle ergometer (45 min at 65%VO2max) immediately followed by a treadmill test (75% VO2max to exhaustion)) before and after the supplementation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Ultra-endurance athletes with at least one gastrointestinal symptoms will be administered oral rehydration salts supplemented with L. Rhamnosus GG or oral rehydration salts only for 4 weeks
| Arm | Type | Receives |
|---|---|---|
| Oral Rehydration Salts supplemented with L. Rhamnosus GG | Experimental | Dietary Supplement: Oral Rehydration Salts onlya supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides |
| Oral Rehydration Salts only | Experimental | Dietary Supplement: Oral Rehydration Salts supplemented with L. Rhamnosus GGA supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants who train at least 15 h per week,
- Participants who do not have any metabolic disease,
- Have had at least one gastrointestinal symptom determined by using a Gastrointestinal Symptoms Rating Scale and Bristol Stool Chart Form Scale,
- Being a non-smoker,
- Have participated in at least one ultra-endurance race/event (lasts > 4 hr),
Key exclusion criteria (4 listed)
- Regular tobacco use
- Inability to adhere to any of the study protocol requirements (i.e. alcohol, caffeine consumption, diet control)
- Having consumed any supplements and/or medicines for the preceding 3 months period.
- (For women) participants in menopause or using oral contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Rehydration Salts supplemented with L. Rhamnosus GGA supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides | Dietary supplement | Oral Rehydration Salts only |
| Oral Rehydration Salts onlyA supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose | Dietary supplement | Oral Rehydration Salts supplemented with L. Rhamnosus GG |
Primary outcome
Changes of the gut microbiome after a 4-week supplementation period
Time frame: Change from Baseline Gut Microbiome at 4 weeks
- To assess the profile of gut flora (% abundance of various bacterial phyla, families, genera and species) at baseline and after supplementation in ultra-endurance athletes, using a 16S ribosomal RNA sequencing
1 secondary outcome
Changes in blood markers of exercise-associated oxidative stress (8-isoprostaglandin 2Fa, Total Antioxidant Capacity, and Total Oxidant Capacity in plasma)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 28781178Krabak BJ, Lipman GS, Waite BL, Rundell SD. Exercise-Associated Hyponatremia, Hypernatremia, and Hydration Status in Multistage Ultramarathons. Wilderness Environ Med. 2017 Dec;28(4):291-298. doi: 10.1016/j.wem.2017.05.008. Epub 2017 Aug 7.
- Results publication: PubMed 31208096Nocella C, Cammisotto V, Pigozzi F, Borrione P, Fossati C, D'Amico A, Cangemi R, Peruzzi M, Gobbi G, Ettorre E, Frati G, Cavarretta E, Carnevale R; SMiLe Group. Impairment between Oxidant and Antioxidant Systems: Short- and Long-term Implications for Athletes' Health. Nutrients. 2019 Jun 15;11(6):1353. doi: 10.3390/nu11061353.
- Results publication: PubMed 8665277Pyne DB. Exercise-induced muscle damage and inflammation: a review. Aust J Sci Med Sport. 1994 Sep-Dec;26(3-4):49-58.
- Results publication: PubMed 7958646Lopez AA, Preziosi JP, Chateau P, Auguste P, Plique O. [Digestive disorders and self medication observed during a competition in endurance athletes. Prospective epidemiological study during a championship of triathlon]. Gastroenterol Clin Biol. 1994;18(4):317-22. French.
- Results publicationMaughan RJ, Shirreffs SM. Sports Beverages for Optimizing Physical Performance. In: Wilson T., Temple N. (eds) Beverage Impacts on Health and Nutrition. Nutrition and Health. Humana Press, Cham. 2016.
- Results publication: PubMed 30356594Mach N, Fuster-Botella D. Endurance exercise and gut microbiota: A review. J Sport Health Sci. 2017 Jun;6(2):179-197. doi: 10.1016/j.jshs.2016.05.001. Epub 2016 May 10.
- Results publication: PubMed 30056755Hoffman MD, Stellingwerff T, Costa RJS. Considerations for ultra-endurance activities: part 2 - hydration. Res Sports Med. 2019 Apr-Jun;27(2):182-194. doi: 10.1080/15438627.2018.1502189. Epub 2018 Jul 28.
- Results publication: PubMed 11352068Hooper LV, Gordon JI. Commensal host-bacterial relationships in the gut. Science. 2001 May 11;292(5519):1115-8. doi: 10.1126/science.1058709.
- Results publication: PubMed 17962710Kekkonen RA, Vasankari TJ, Vuorimaa T, Haahtela T, Julkunen I, Korpela R. The effect of probiotics on respiratory infections and gastrointestinal symptoms during training in marathon runners. Int J Sport Nutr Exerc Metab. 2007 Aug;17(4):352-63. doi: 10.1123/ijsnem.17.4.352.
- Results publication: PubMed 21400082Martarelli D, Verdenelli MC, Scuri S, Cocchioni M, Silvi S, Cecchini C, Pompei P. Effect of a probiotic intake on oxidant and antioxidant parameters in plasma of athletes during intense exercise training. Curr Microbiol. 2011 Jun;62(6):1689-96. doi: 10.1007/s00284-011-9915-3. Epub 2011 Mar 12.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba Kocahan, MD study director
Centre of Athlete Training and Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Rehydration Salts supplemented with L. Rhamnosus GG and Oral Rehydration Salts only in people with Ultra-endurance Athletes With Gastrointestinal Symptoms, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the gut microbiome after a 4-week supplementation period (time frame: Change from Baseline Gut Microbiome at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779281, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.