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HealthyPhase 1NCT01879098

The Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation

A Phase 1 study testing Probiotic: Bacillus subtilis, Lactobacillus plantarum and Bifidobacterium animalis in people with Healthy, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this research study is to determine whether a probiotic can change the way bile is used by the body. The investigators will also look at the effect of the probiotic on your intestinal health. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Probiotic: Bacillus subtilis, Lactobacillus plantarum and Bifidobacterium animalis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
155 participants
Where
1 siteUnited States
Study dates
Aug 2013to Jun 2014
Phase
Phase 1
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 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To participate in the study you must:
  • Be 35-65 years of age.
  • Have a waist circumference > 102 cm (40 in) for males, and > 88 cm (35 in) for females.
  • Be willing and able to complete the Informed Consent Form in English.
  • Be available for 18 consecutive weeks to participate in this study.
  • Be willing and able to complete daily and weekly questionnaires regarding general wellness, bowel function, gastrointestinal symptoms, physical activity level, and dietary intake.
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  • Be willing to provide 4 blood samples and 4 stool samples.
  • Be willing to maintain your regular level of physical activity and your diet for 18-week study.
  • Be able to take the study supplement without the aid of another person.
  • Be willing to discontinue consumption of fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements).
  • Be willing to provide a social security number (SS#) to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.

Who cannot join

  • To participate in the study you must NOT:
  • Fail to meet any of the criteria I mentioned above.
  • Consume >20 g fiber daily, according to the Block Fiber Screener.
  • Be taking any statins or cholesterol-lowering prescription drugs now, or within the last 6 months.
  • Be currently taking any constipation or diarrhea on a regular basis.
  • Be currently taking any systemic corticosteroids, androgens (such as testosterone), or large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
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  • Have used plant sterols, n-3 fatty acids, fish oil, soy protein, soluble oat fiber, psyllium seed husk or other cholesterol-lowering supplements within the last 3 months.
  • Have received antibiotic therapy or a colonoscopy in the past two months.
  • Currently be treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, colostomy, but not including Gastroesophageal Reflux Disease (GERD); or have a central venous catheter.
  • Taking medications for type 1 or type 2 diabetes.
  • Be physically active or very physically active. Active = typical daily living activities PLUS at least 60 minutes of daily moderate activity. Very active = typical daily living activities PLUS at least 60 minutes of daily moderate activity, PLUS an additional 60 minutes of vigorous activity OR 120 minutes of moderate activity.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida

    Gainesville, Florida, 32611

Other trials in United States

About this study

Official title: Evaluation of the Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation in Healthy, Middle-aged Adults: a Randomized, Double-blinded, Placebo-controlled Study

The purpose of this research study is to determine whether a probiotic can change the way bile is used by the body. The investigators will also look at the effect of the probiotic on your intestinal health.

Read the detailed description

This is a randomized, double-blind, placebo controlled crossover study. After obtaining informed consent, healthy, middle-aged adults with a larger waist circumference (n=30/probiotic cross with n=90 total/study) will be randomized to one of four groups: Bacillus subtilis, Lactobacillus plantarum, Bifidobacterium animalis subsp. lactis, or placebo. Participants will consume 1 capsule per day of probiotic or placebo for 6 weeks. After a 4-week washout period, participants will be crossed to the other treatment (i.e., probiotic to placebo or placebo to probiotic).

Participants will complete daily questionnaires throughout the intervention period, and one week before and after each intervention period. Blood samples will be collected at the baseline and final time points (±3 days) of each intervention. Stool samples will be collected during the pre-baseline and final weeks of each intervention. Dietary intake will be assessed weekly during each intervention period. Gastrointestinal symptoms and physical activity questionnaires will be completed weekly during each intervention period and also the weeks before and after each intervention period.

Conditions
Healthy
Being tested
Probiotic: Bacillus subtilis, Lactobacillus plantarum, Bifidobacterium animalis, Placebo
Keywords
probiotics, inflammation, bile, hunger, satiety
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic: Bacillus subtilisDietary supplement

    Also called Bacillus subtilis R0179

    Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).

  • Lactobacillus plantarumDietary supplement

    Also called Lactobacillus plantarum HA-119

    Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).

  • Bifidobacterium animalisDietary supplement

    Also called Bifidobacterium animalis subsp. lactis LAFTI B94

    Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).

  • PlaceboDietary supplement

    Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).

Study groups in NCT01879098
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Receives: Dietary Supplement: Placebo
Probiotic: Bacillus subtilisExperimentalBacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Receives: Dietary Supplement: Probiotic: Bacillus subtilis
Probiotic: Lactobacillus plantarumExperimentalLactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Receives: Dietary Supplement: Lactobacillus plantarum
Probiotic: Bifidobacterium animalisExperimentalBifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Receives: Dietary Supplement: Bifidobacterium animalis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in deconjugated bile acids in the blood

    Levels of deconjugated bile acids in the stool and in the blood will be compared between treatment periods for each subject/group.

    Measured: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18

Secondary outcomes (1)

  1. Satiety and glucose metabolism

    Levels of hormones associated with hunger, satiety and glucose metabolism in the blood will be compared between treatment periods for each subject/group. Daily questionnaires will also assess hunger/satiety.

    Measured: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01879098
Sponsor's protocol ID
IRB# 70-2013
Status last verified
Jul 2014
First submitted
12 Jun 2013
Last updated
10 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • Culpepper T, Rowe CC, Rusch CT, Burns AM, Federico AP, Girard SA, Tompkins TA, Nieves C Jr, Dennis-Wall JC, Christman MC, Langkamp-Henken B. Three probiotic strains exert different effects on plasma bile acid profiles in healthy obese adults: randomised, double-blind placebo-controlled crossover study. Benef Microbes. 2019 May 28;10(5):497-509. doi: 10.3920/BM2018.0151. Epub 2019 May 15.

    PubMed 31090458

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Probiotic: Bacillus subtilis, Lactobacillus plantarum and Bifidobacterium animalis 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 11 inclusion and 11 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 10 Jul 2014. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Difference in deconjugated bile acids in the blood (time frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18). 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 NCT01879098, which also lists 1 linked publication.

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 10 Jul 2014.

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