HealthyNCT01709825
The Effect of Probiotics (L. Helveticus, B. Longum, and B. Bifidum) on Immune Function and Digestive Health
A study testing Probiotic- Bifidobacterium Bifidum, Sugar Pill and Probiotic- Lactobacillus helveticus in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine if daily consumption of a probiotic in the period before, during and after academic exams will help maintain digestive and immune health and quality of life of undergraduate students. 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- Bifidobacterium Bifidum, Sugar Pill and Probiotic- Lactobacillus helveticus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 583 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2013
- 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
- To participate in the study you must:
- be 18 years of age or older.
- be a healthy full-time undergraduate at the University of Florida.
- be willing to complete daily questionnaires form via computer.
- be 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).
- be willing to take the probiotic capsule daily of 6 weeks.
Show all 9Show fewer
- have had at least one cold in the last 12 months.
- have at least 1 final during the scheduled exam week.
- have daily access to the Internet.
Who cannot join
- To participate in the study you must NOT:
- be a current smoker.
- have chronic allergies involving the upper respiratory tract.
- have had immunosuppressive illness or treatment within the last year.
- have received antibiotic therapy in the past two months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Probiotics on Immune Function, and Digestive Health in Academically-stressed University Students: A Randomized, Double-blinded, Placebo-controlled Study
The purpose of this study is to determine if daily consumption of a probiotic in the period before, during and after academic exams will help maintain digestive and immune health and quality of life of undergraduate students.
Read the detailed description
A randomized, double-blinded, placebo-controlled trial will be used. Healthy full-time undergraduate students will be recruited from the University of Florida via flyers, emails, announcements, etc. Informed consent will be obtained and the inclusion/exclusion criteria will be reviewed to determine whether a participant qualifies for the study. All participants will be consented for the main six-week intervention and a subgroup (n=50/group) of these students will be consented to provide two stool samples.
Participants will provide saliva and stool samples (for the sub-group)during the pre-baseline week and during the week of final exams at approximately week 4. At the randomization visit, height, weight and age will be obtained. Participants will be stratified based on body mass index and randomized via sealed envelopes to one of four groups: Lactobacillus helveticus, Bifidobacterium longum ssp. Infantis, Bifidobacterium bifidum or the placebo (n=145/group). Participants will take the study provided capsule of probiotic or placebo daily for 6 weeks. Participants will receive daily questionnaires via email throughout the prebaseline week and the 6-week intervention. Daily questionnaires will ask about intake of the supplement, cold symptoms, and general health (i.e., new medications, doctor visits). Throughout the study, participants will also be asked to complete weekly questionnaires (inquiring about gastrointestinal symptoms and physical activity) and Quality of Life Questionnaires (administered during pre-baseline, final exam week and week 6 of the study).
- Conditions
- Healthy
- Being tested
- Probiotic- Bifidobacterium Bifidum, Sugar Pill, Probiotic- Lactobacillus helveticus, Probiotic- Bifidobacterium longum ss. Infantis R0033
- Keywords
- probiotics, cold, flu, immune function, microbiota
- Medical subject headings
- Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic- Bifidobacterium BifidumDietary supplement
Also called Bifidobacterium bifidum, Supplement A
Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks.
Sugar PillDietary supplement
Also called Sucrose
Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks.
Probiotic- Lactobacillus helveticusDietary supplement
Also called Lactobacillus helveticus, Supplement B
Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks.
Probiotic- Bifidobacterium longum ss. Infantis R0033Dietary supplement
Also called Bifidobacterium longum ss. Infantis R0033, Supplement C
Bifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Sugar Pill will be taken as a capsule once daily for 6 weeks. Receives: Dietary Supplement: Sugar Pill |
| Probiotic- Bifidobacterium bifidum | Experimental | Bifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks. Receives: Dietary Supplement: Probiotic- Bifidobacterium Bifidum |
| Probiotic- Lactobacillus helveticus | Experimental | Lactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks. Receives: Dietary Supplement: Probiotic- Lactobacillus helveticus |
| Probiotic- Bifidobacterium longum ss. Infantis R0033 | Experimental | Bifidobacterium longum ss. Infantis R0033 (Supplement C)will be taken as a capsule once daily for 6 weeks. Receives: Dietary Supplement: Probiotic- Bifidobacterium longum ss. Infantis R0033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of days without cold/flu
The intensity of cold/flu symptoms (running/congested nose, stiffness or chills, headache, cough, fatigue, fever, sore throat, achiness, and ear discomfort)will be scored as 0 (not experiencing) to 3 (severe). The symptom intensity from the 9 cold/flu symptoms will be summed to obtain a symptom intensity score. A symptom intensity score of >6 will be designated as a day of cold. The mean proportion of days without a cold/flu will be compared between each probiotic and the placebo.
Measured: over 6 weeks
Microbiota Study
- Microbial diversity measured by DGGE profiling (detect large distortions)
- qPCR to quantify treatment effects on specific bacteria
Measured: Change in microbiota from pre-baseline to on average week 4
Digestive Health
- Gastrointestinal symptoms (gas, bloating, diarrhea, etc.)
- Bowel habits (bowel movement frequency and consistency)
- Measures of quality of life (physical functioning, general health, bodily pain, vitality and social functioning)
Measured: Daily for 7 weeks
Secondary outcomes (1)
Immune Health
- Salivary secretory immunoglobulin A (sIgA)
- Fecal sIgA
Measured: Measured at pre-baseline and on average week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Human Nutrition
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, RD, Principal investigator, University of FloridaWendy Dahl, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709825
- Sponsor's protocol ID
- 403-2012
- Status last verified
- Jan 2015
- First submitted
- 11 Oct 2012
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Langkamp-Henken B, Rowe CC, Ford AL, Christman MC, Nieves C Jr, Khouri L, Specht GJ, Girard SA, Spaiser SJ, Dahl WJ. Bifidobacterium bifidum R0071 results in a greater proportion of healthy days and a lower percentage of academically stressed students reporting a day of cold/flu: a randomised, double-blind, placebo-controlled study. Br J Nutr. 2015 Feb 14;113(3):426-34. doi: 10.1017/S0007114514003997. Epub 2015 Jan 21.
PubMed 25604727Culpepper T, Christman MC, Nieves C Jr, Specht GJ, Rowe CC, Spaiser SJ, Ford AL, Dahl WJ, Girard SA, Langkamp-Henken B. Bifidobacterium bifidum R0071 decreases stress-associated diarrhoea-related symptoms and self-reported stress: a secondary analysis of a randomised trial. Benef Microbes. 2016 Jun;7(3):327-36. doi: 10.3920/BM2015.0156. Epub 2016 Feb 3.
PubMed 26839075
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Immune Function, and Digestive Health in Academically-stressed University Students: A Randomized, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01709825
- Acronym / sponsor ID
- 403-2012
- Conditions
- Healthy
- Keywords
- probiotics, cold, flu, immune function, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Lallemand Human Nutrition
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Oct 2012 (estimated)
- 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 study is to determine if daily consumption of a probiotic in the period before, during and after academic exams will help maintain digestive and immune health and quality of life of undergraduate students.
Detailed description
A randomized, double-blinded, placebo-controlled trial will be used. Healthy full-time undergraduate students will be recruited from the University of Florida via flyers, emails, announcements, etc. Informed consent will be obtained and the inclusion/exclusion criteria will be reviewed to determine whether a participant qualifies for the study. All participants will be consented for the main six-week intervention and a subgroup (n=50/group) of these students will be consented to provide two stool samples.
Participants will provide saliva and stool samples (for the sub-group)during the pre-baseline week and during the week of final exams at approximately week 4. At the randomization visit, height, weight and age will be obtained. Participants will be stratified based on body mass index and randomized via sealed envelopes to one of four groups: Lactobacillus helveticus, Bifidobacterium longum ssp. Infantis, Bifidobacterium bifidum or the placebo (n=145/group). Participants will take the study provided capsule of probiotic or placebo daily for 6 weeks. Participants will receive daily questionnaires via email throughout the prebaseline week and the 6-week intervention. Daily questionnaires will ask about intake of the supplement, cold symptoms, and general health (i.e., new medications, doctor visits). Throughout the study, participants will also be asked to complete weekly questionnaires (inquiring about gastrointestinal symptoms and physical activity) and Quality of Life Questionnaires (administered during pre-baseline, final exam week and week 6 of the study).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Dietary Supplement: Sugar PillSugar Pill will be taken as a capsule once daily for 6 weeks. |
| Probiotic- Bifidobacterium bifidum | Experimental | Dietary Supplement: Probiotic- Bifidobacterium BifidumBifidobacterium bifidum (Supplement A) will be taken as a capsule once daily for 6 weeks. |
| Probiotic- Lactobacillus helveticus | Experimental | Dietary Supplement: Probiotic- Lactobacillus helveticusLactobacillus helveticus (Supplement B) will be taken as a capsule once daily for 6 weeks. |
| Probiotic- Bifidobacterium longum ss. Infantis R0033 | Experimental | Dietary Supplement: Probiotic- Bifidobacterium longum ss. Infantis R0033Bifidobacterium longum ss. Infantis R0033 (Supplement C)will be taken as a capsule once daily for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- be 18 years of age or older.
- be a healthy full-time undergraduate at the University of Florida.
- be willing to complete daily questionnaires form via computer.
- be 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).
- be willing to take the probiotic capsule daily of 6 weeks.
Key exclusion criteria (5 listed)
- be a current smoker.
- have chronic allergies involving the upper respiratory tract.
- have had immunosuppressive illness or treatment within the last year.
- have received antibiotic therapy in the past two months.
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 |
|---|---|---|
| Probiotic- Bifidobacterium BifidumAlso: Bifidobacterium bifidum, Supplement ABifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks. | Dietary supplement | Probiotic- Bifidobacterium bifidum |
| Sugar PillAlso: SucroseSugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks. | Dietary supplement | Sugar Pill |
| Probiotic- Lactobacillus helveticusAlso: Lactobacillus helveticus, Supplement BLactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks. | Dietary supplement | Probiotic- Lactobacillus helveticus |
| Probiotic- Bifidobacterium longum ss. Infantis R0033Also: Bifidobacterium longum ss. Infantis R0033, Supplement CBifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks. | Dietary supplement | Probiotic- Bifidobacterium longum ss. Infantis R0033 |
Primary outcome
Proportion of days without cold/flu
Time frame: over 6 weeks
The intensity of cold/flu symptoms (running/congested nose, stiffness or chills, headache, cough, fatigue, fever, sore throat, achiness, and ear discomfort)will be scored as 0 (not experiencing) to 3 (severe). The symptom intensity from the 9 cold/flu symptoms will be summed to obtain a symptom intensity score. A symptom intensity score of >6 will be designated as a day of cold. The mean proportion of days without a cold/flu will be compared between each probiotic and the placebo.
Microbiota Study
Time frame: Change in microbiota from pre-baseline to on average week 4
* Microbial diversity measured by DGGE profiling (detect large distortions) * qPCR to quantify treatment effects on specific bacteria
Digestive Health
Time frame: Daily for 7 weeks
* Gastrointestinal symptoms (gas, bloating, diarrhea, etc.) * Bowel habits (bowel movement frequency and consistency) * Measures of quality of life (physical functioning, general health, bodily pain, vitality and social functioning)
1 secondary outcome
Immune Health
Time frame: Measured at pre-baseline and on average week 4
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 29 Jan 2015.
- Results publication: PubMed 25604727Langkamp-Henken B, Rowe CC, Ford AL, Christman MC, Nieves C Jr, Khouri L, Specht GJ, Girard SA, Spaiser SJ, Dahl WJ. Bifidobacterium bifidum R0071 results in a greater proportion of healthy days and a lower percentage of academically stressed students reporting a day of cold/flu: a randomised, double-blind, placebo-controlled study. Br J Nutr. 2015 Feb 14;113(3):426-34. doi: 10.1017/S0007114514003997. Epub 2015 Jan 21.
- Derived from this study: PubMed 26839075Culpepper T, Christman MC, Nieves C Jr, Specht GJ, Rowe CC, Spaiser SJ, Ford AL, Dahl WJ, Girard SA, Langkamp-Henken B. Bifidobacterium bifidum R0071 decreases stress-associated diarrhoea-related symptoms and self-reported stress: a secondary analysis of a randomised trial. Benef Microbes. 2016 Jun;7(3):327-36. doi: 10.3920/BM2015.0156. Epub 2016 Feb 3.
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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
Wendy Dahl, 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- Bifidobacterium Bifidum, Sugar Pill and Probiotic- Lactobacillus helveticus 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 9 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 29 Jan 2015. 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?
Proportion of days without cold/flu (time frame: over 6 weeks). The study lists 3 primary outcomes in all. 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 NCT01709825, which also lists 2 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 29 Jan 2015.