HealthySASNCT03056846
Probiotics on Stress-associated Gastrointestinal Function in University Students
A study testing Probiotic Combination, Bifidobacterium bifidum and Bifidobacterium longum in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the effect of a daily supplement of probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2) on stress-associated gastrointestinal function in university students during the time of semester exams. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic Combination, Bifidobacterium bifidum and Bifidobacterium longum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 634 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 5 Feb 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Healthy full-time undergraduate student at the University of Florida
- Willing and able to consume a daily supplement (probiotic or placebo) for the duration of the 6-week study
- Willing and able to complete daily questionnaires online regarding general health and well-being, including stress levels and gastrointestinal symptoms (Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided)
- Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, Echinacea, fish oil, vitamin E [>400% of the RDA or >60 mg/day])
- Had a cold/flu within the past year
Who cannot join
- Currently smoke
- Women who are lactating, know that they are pregnant, or are attempting to get pregnant
- Currently taking any systemic corticosteroids
- Currently being treated for any physician-diagnosed diseases
- Have received chemotherapy or other immune suppressing therapy within the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) on Stress-associated Gastrointestinal Function in University Students: a Randomized, Double-blind, Placebo-controlled Clinical Trial
The purpose of this research study is to evaluate the effect of a daily supplement of probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2) on stress-associated gastrointestinal function in university students during the time of semester exams.
Read the detailed description
In this randomized, double-blind, placebo-controlled study, undergraduate students planning to take a fall final exam will receive a daily probiotic combination, individual probiotic, or placebo for 6 weeks. Questionnaires will assess gastrointestinal symptoms, immune health, stress and stress management, quality of life, diet, adverse events, and compliance. In a subset of subjects, stool samples will be collected at baseline and at week 5 of the intervention (the week before final exams) to characterize microbial communities.
- Conditions
- Healthy
- Being tested
- Placebo, Probiotic Combination, Bifidobacterium bifidum, Bifidobacterium longum
- Keywords
- probiotic, gastrointestinal, stress, student
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Probiotic CombinationDietary supplement
Also called Kyo-Dophilus, Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2
A capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Bifidobacterium bifidumDietary supplement
Also called Kyo-Dophilus, Bifidobacterium bifidum G9-1
A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Bifidobacterium longumDietary supplement
Also called Kyo-Dophilus, Bifidobacterium longum MM-2
A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Receives: Dietary Supplement: Placebo |
| Probiotic Combination | Experimental | A commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Receives: Dietary Supplement: Probiotic Combination |
| Bifidobacterium bifidum | Experimental | A commercially available probiotic strain (Bifidobacterium bifidum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Receives: Dietary Supplement: Bifidobacterium bifidum |
| Bifidobacterium longum | Experimental | A commercially available probiotic strain (Bifidobacterium longum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Receives: Dietary Supplement: Bifidobacterium longum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score
Weekly GSRS constipation symptom score in probiotic mixture vs. individual probiotic vs. placebo
Measured: Baseline (Week 0) to Final (Week 6)
Secondary outcomes (9)
Change in diarrhea symptoms, measured by GSRS
Weekly GSRS diarrhea symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Measured: Baseline (Week 0) to Final (Week 6)
Change in abdominal pain symptoms, measured by GSRS
Weekly GSRS abdominal pain symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Measured: Baseline (Week 0) to Final (Week 6)
Change in indigestion symptoms, measured by GSRS
Weekly GSRS indigestion symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Measured: Baseline (Week 0) to Final (Week 6)
Change in reflux symptoms, measured by GSRS
Weekly GSRS reflux symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Measured: Baseline (Week 0) to Final (Week 6)
Weekly average of daily levels of stress
Daily stress (0 = no stress to 10 = severe or extreme stress)
Measured: Baseline (Week 0) to Final (Week 6)
Microbiota studies, measured by 16S rRNA sequence analysis
Microbial diversity measured by 16S rRNA sequence analysis
Measured: Baseline (Week 0) and Week 5
Microbiota studies, qPCR
qPCR to quantify changes in bacteria of interest
Measured: Baseline (Week 0) and Week 5
Immune health, measured by questionnaire data
Proportion of healthy days (i.e., days without cold symptoms with an intensity >6). Daily health questionnaires ask students about non-allergy-related cold symptoms (running/congested nose, stiffness or chills, headache, cough, fatigue, fever, sore throat, achiness, and ear discomfort) and symptom intensity (0=none, 1=mild, 2=moderate, 3=severe)
Measured: Baseline (Week 0) to Final (Week 6)
Immune function, measured by questionnaire data
Symptom intensity score (average sum of symptom intensities)
Measured: Baseline (Week 0) to Final (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start5 Sep 2017
- Primary completion21 Dec 2017
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056846
- Sponsor's protocol ID
- IRB201600917
- Acronym
- SAS
- Status last verified
- Mar 2019
- First submitted
- 26 Aug 2016
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) on Stress-associated Gastrointestinal Function in University Students: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03056846
- Acronym / sponsor ID
- SAS / IRB201600917
- Conditions
- Healthy
- Keywords
- probiotic, gastrointestinal, stress, student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 17 Feb 2017 (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.
The purpose of this research study is to evaluate the effect of a daily supplement of probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2) on stress-associated gastrointestinal function in university students during the time of semester exams.
Detailed description
In this randomized, double-blind, placebo-controlled study, undergraduate students planning to take a fall final exam will receive a daily probiotic combination, individual probiotic, or placebo for 6 weeks. Questionnaires will assess gastrointestinal symptoms, immune health, stress and stress management, quality of life, diet, adverse events, and compliance. In a subset of subjects, stool samples will be collected at baseline and at week 5 of the intervention (the week before final exams) to characterize microbial communities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
| Probiotic Combination | Experimental | Dietary Supplement: Probiotic CombinationA commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
| Bifidobacterium bifidum | Experimental | Dietary Supplement: Bifidobacterium bifidumA commercially available probiotic strain (Bifidobacterium bifidum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
| Bifidobacterium longum | Experimental | Dietary Supplement: Bifidobacterium longumA commercially available probiotic strain (Bifidobacterium longum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Healthy full-time undergraduate student at the University of Florida
- Willing and able to consume a daily supplement (probiotic or placebo) for the duration of the 6-week study
- Willing and able to complete daily questionnaires online regarding general health and well-being, including stress levels and gastrointestinal symptoms (Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided)
- Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, Echinacea, fish oil, vitamin E [>400% of the RDA or >60 mg/day])
Key exclusion criteria (5 listed)
- Currently smoke
- Women who are lactating, know that they are pregnant, or are attempting to get pregnant
- Currently taking any systemic corticosteroids
- Currently being treated for any physician-diagnosed diseases
- Have received chemotherapy or other immune suppressing therapy within the last year
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 |
|---|---|---|
| PlaceboPlacebo will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). | Dietary supplement | Placebo |
| Probiotic CombinationAlso: Kyo-Dophilus, Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2A capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). | Dietary supplement | Probiotic Combination |
| Bifidobacterium bifidumAlso: Kyo-Dophilus, Bifidobacterium bifidum G9-1A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). | Dietary supplement | Bifidobacterium bifidum |
| Bifidobacterium longumAlso: Kyo-Dophilus, Bifidobacterium longum MM-2A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica. | Dietary supplement | Bifidobacterium longum |
Primary outcome
Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score
Time frame: Baseline (Week 0) to Final (Week 6)
Weekly GSRS constipation symptom score in probiotic mixture vs. individual probiotic vs. placebo
9 secondary outcomes
Change in diarrhea symptoms, measured by GSRS
Time frame: Baseline (Week 0) to Final (Week 6)
Change in abdominal pain symptoms, measured by GSRS
Time frame: Baseline (Week 0) to Final (Week 6)
Change in indigestion symptoms, measured by GSRS
Time frame: Baseline (Week 0) to Final (Week 6)
Change in reflux symptoms, measured by GSRS
Time frame: Baseline (Week 0) to Final (Week 6)
Weekly average of daily levels of stress
Time frame: Baseline (Week 0) to Final (Week 6)
Microbiota studies, measured by 16S rRNA sequence analysis
Time frame: Baseline (Week 0) and Week 5
Microbiota studies, qPCR
Time frame: Baseline (Week 0) and Week 5
Immune health, measured by questionnaire data
Time frame: Baseline (Week 0) to Final (Week 6)
Immune function, measured by questionnaire data
Time frame: Baseline (Week 0) to Final (Week 6)
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 25 Mar 2019.
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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.
Bobbi Langkamp-Henken, PhD, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Combination, Bifidobacterium bifidum and Bifidobacterium longum in people with Healthy, run by University of Florida 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 6 inclusion and 5 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 25 Mar 2019. 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?
Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score (time frame: Baseline (Week 0) to Final (Week 6)). 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 25 Mar 2019.