Gastrointestinal DiscomfortNCT05425329
Safety and Efficacy of a Probiotic Supplement
A study testing I3.1 in people with Gastrointestinal Discomfort, run by University of Memphis at 1 site in United States.
Trial summary
Exercise-induced gastrointestinal dysfunction is common amongst endurance athletes and is characterized by gastrointestinal permeability, also known as "leaky gut." Probiotics have been shown to improve gut permeability through the secretion of mucin, immunoglobulin A and improvement in stability of tight junctions… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Discomfort
- What is being tested?
- I3.1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Dec 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, females between 18-50 years of age
- Healthy and injury free as determined by screening questions and medical history
- Distance runners as determined by physical activity questionnaire; run = 15 miles/week, run = 3 time or more/week
- VO2max level of = 40ml/kg/min for males or = 35ml/kg/min for females
- Agree to maintain normal diet and exercise routine throughout study
- Agrees to collect stool samples as needed
- Agree to complete questionnaires, records
Who cannot join
- Women who are pregnant or breastfeeding, or plan to become pregnant during course of the study will not be included as the effect of probiotic on pregnancy and lactation is not established.
- Subjects with a known allergy to the test material (active and placebo)
- Subjects taking NSAIDs, Metformin, probiotics, or supplements that might alter the gut microbiome;these will be assessed individually. (Multivitamin and protein supplementation are allowed)
- Subject that have abnormal test results during screening.
- Alcohol or drug abuse within past year (alcohol can impair gut barrier).
- History of GI surgery within past year as it would alter the gut microbiome (excluding appendectomy and herniorrhaphy).
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- Severe heart, liver, kidney, neurological, oncological or psychiatric disease, or immunosuppressed subjects will be excluded.
- Coeliac disease, inflammatory bowel disease or acute pancreatitis (all 3 can impair gut barrier)
- Regular use of antacid medication (can significantly alter microbiota)
- Subject following a low FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) diet will be excluded as this dietary pattern can alter the intestinal response to exercise in some people.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of a Probiotic Supplement: Focus on Lessening Gastrointestinal Distress in Endurance Athletes
Exercise-induced gastrointestinal dysfunction is common amongst endurance athletes and is characterized by gastrointestinal permeability, also known as "leaky gut." Probiotics have been shown to improve gut permeability through the secretion of mucin, immunoglobulin A and improvement in stability of tight junctions between epithelial cells. This study will determine the efficacy of a probiotic containing the bacterial strains P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485) in altering markers of gut inflammation and dysfunction, and symptoms of gastrointestinal distress.
Read the detailed description
This study is a randomized, placebo-controlled, double-blinded crossover study where trained runners that experience moderate gastrointestinal discomfort with exhaustive runs will be subjected to the probiotic intervention/placebo supplementation for one month with a one month washout period. The intervention consists of the probiotic strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1 at a dose of 3b cfu/day. Probiotic/Placebo capsules will be taken once daily. Biological samples and symptom data collection will be collected at baseline and after one month of probiotic/placebo supplementation. Data are also collected after an in-house treadmill run after one month of supplementation.
- Conditions
- Gastrointestinal Discomfort
- Being tested
- I3.1, Placebo treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I3.1Dietary supplement
Capsule containing bacterial strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1.
Placebo treatmentDietary supplement
Capsule containing maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic treatment | Experimental | P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485 in a ration of 1:1:1 at a dose of 3b cfu/day. Receives: Dietary Supplement: I3.1 |
| Placebo treatment | Placebo comparator | Capsules indistinguishable from intervention containing maltodextrin. Receives: Dietary Supplement: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of probiotic supplementation on intestinal fatty acid binding protein (iFABP) levels.
Determine concentration (pg/ml) of iFABP in serum
Measured: 4 weeks
Effect of probiotic supplementation on lipopolysaccharide binding protein (LBP) levels
Determine concentration (ng/ml) of LBP in serum
Measured: 4 weeks
Effect of probiotic supplementation on zonulin levels
Determine concentration (ng/ml) of zonulin in serum
Measured: 4 weeks
Effect of probiotic supplementation on calprotectin levels
Determine concentration (ug/g) of calprotectin in feces.
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 posted21 Jun 2022
- Study start1 Aug 2020
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiscomfortStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie van der Merwe, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425329
- Sponsor's protocol ID
- PRO-FY2020-304
- Status last verified
- Jun 2022
- First submitted
- 16 May 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Probiotic Supplement: Focus on Lessening Gastrointestinal Distress in Endurance Athletes
- ClinicalTrials.gov ID
- NCT05425329
- Acronym / sponsor ID
- PRO-FY2020-304
- Conditions
- Gastrointestinal Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Jun 2022 (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.
Exercise-induced gastrointestinal dysfunction is common amongst endurance athletes and is characterized by gastrointestinal permeability, also known as "leaky gut." Probiotics have been shown to improve gut permeability through the secretion of mucin, immunoglobulin A and improvement in stability of tight junctions between epithelial cells. This study will determine the efficacy of a probiotic containing the bacterial strains P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485) in altering markers of gut inflammation and dysfunction, and symptoms of gastrointestinal distress.
Detailed description
This study is a randomized, placebo-controlled, double-blinded crossover study where trained runners that experience moderate gastrointestinal discomfort with exhaustive runs will be subjected to the probiotic intervention/placebo supplementation for one month with a one month washout period. The intervention consists of the probiotic strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1 at a dose of 3b cfu/day. Probiotic/Placebo capsules will be taken once daily. Biological samples and symptom data collection will be collected at baseline and after one month of probiotic/placebo supplementation. Data are also collected after an in-house treadmill run after one month of supplementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic treatment | Experimental | Dietary Supplement: I3.1P. acidilatici, CECT 7483, L. plantarum CECT 7484, L. plantarum CECT7485 in a ration of 1:1:1 at a dose of 3b cfu/day. |
| Placebo treatment | Placebo comparator | Dietary Supplement: Placebo treatmentCapsules indistinguishable from intervention containing maltodextrin. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males, females between 18-50 years of age
- Healthy and injury free as determined by screening questions and medical history
- Distance runners as determined by physical activity questionnaire; run = 15 miles/week, run = 3 time or more/week
- VO2max level of = 40ml/kg/min for males or = 35ml/kg/min for females
- Agree to maintain normal diet and exercise routine throughout study
Key exclusion criteria (10 listed)
- Women who are pregnant or breastfeeding, or plan to become pregnant during course of the study will not be included as the effect of probiotic on pregnancy and lactation is not established.
- Subjects with a known allergy to the test material (active and placebo)
- Subjects taking NSAIDs, Metformin, probiotics, or supplements that might alter the gut microbiome;these will be assessed individually. (Multivitamin and protein supplementation are allowed)
- Subject that have abnormal test results during screening.
- Alcohol or drug abuse within past year (alcohol can impair gut barrier).
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 |
|---|---|---|
| I3.1Capsule containing bacterial strains Lactobacillus plantarum (CECT7484 and CECT7485) and Pediococcus acidilactici (CECT7483) at a ratio of 1:1:1. | Dietary supplement | Probiotic treatment |
| Placebo treatmentCapsule containing maltodextrin. | Dietary supplement | Placebo treatment |
Primary outcome
Effect of probiotic supplementation on intestinal fatty acid binding protein (iFABP) levels.
Time frame: 4 weeks
Determine concentration (pg/ml) of iFABP in serum
Effect of probiotic supplementation on lipopolysaccharide binding protein (LBP) levels
Time frame: 4 weeks
Determine concentration (ng/ml) of LBP in serum
Effect of probiotic supplementation on zonulin levels
Time frame: 4 weeks
Determine concentration (ng/ml) of zonulin in serum
Effect of probiotic supplementation on calprotectin levels
Time frame: 4 weeks
Determine concentration (ug/g) of calprotectin in feces.
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 21 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Marie van der Merwe, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I3.1 in people with Gastrointestinal Discomfort, run by University of Memphis at 1 site in United States.
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 10 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 21 Jun 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Effect of probiotic supplementation on intestinal fatty acid binding protein (iFABP) levels. (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2022.