Survival of Probiotics During GI TransitNCT02001610
Acidophilus Pearls Fecal Recovery Study
A study testing Acidophilus pearls and Hard shell gelatin capsules in people with Survival of Probiotics During GI Transit and GI Symptoms, run by University of Florida at 1 site in United States.
Trial summary
Commercial probiotics can be delivered in numerous forms. The two most common delivery forms are similar to the two product formats to be tested. It has been demonstrated using in vitro testing that probiotic organisms that are unprotected from gastric exposure may not survive that exposure and therefore may not… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Survival of Probiotics During GI Transit, GI Symptoms
- What is being tested?
- Acidophilus pearls and Hard shell gelatin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 2014
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult
- Regular and predictable bowel movement pattern
- Willing to disclose OTC/prescription medications and dietary supplements taken during the study
- Willing to sign comprehensive informed consent form
Who cannot join
- Digestive disorders
- Use of prescribed medications that affect bowel function or microbiota (antibiotics, pain medications, laxatives)
- Use of dietary supplements/foods that can affect bowel function or microbiota
- Excessive alcohol use
Trial locations and contacts
1 site in 1 country.
United States1 site
Emerging Pathogens Institute
Gainesville, Florida, 32610
About this study
Official title: Clinical Trial of the Viability of LAB and Bifidobacteria From Acidophilus Pearls in Human Stool Samples
Commercial probiotics can be delivered in numerous forms. The two most common delivery forms are similar to the two product formats to be tested. It has been demonstrated using in vitro testing that probiotic organisms that are unprotected from gastric exposure may not survive that exposure and therefore may not remain viable throughout the rest of the GIT. (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule will survive gastric exposure. It is anticipated that this difference in in vitro gastric survivability will translate to improved digestive tract survivability that can be demonstrated using fecal recovery techniques.
The commercial product to be tested in this clinical trial has been in the market for over 17 years. However, it is not known what effect this commercial product has on the commensal probiotic population in the gut and particularly in the lower bowel where much of probiotic benefits are believed to be largely realized. Also, it is not known what effect the commercial product has on the total commensal microbiota or fecal pH. While commercial probiotic products have been largely aimed at benefits related to improved health, they also have the potential to change overall gut microbiota (probiotics as well as all others) composition and activities. Learning what happens to the overall gut microbiota can be a helpful step in establishing the potential health benefits of the probiotic class of organisms in the test products.
- Being tested
- Acidophilus pearls, Hard shell gelatin capsules
- Keywords
- microbiota, probiotics, fecal markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acidophilus pearlsDietary supplement
- Acidophilus pearls are encapsulated using patented process
- Subjects take one capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days
Hard shell gelatin capsulesDietary supplement
- Hard-shelled gelatin capsule with same microbial formulation as pearl supplement
- Subjects consume one capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days
| Study group | Role | What they receive |
|---|---|---|
| Hard shell gelatin capsules | Active comparator | * Comparison delivery vehicle in the form of gelatin capsule
* One capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days Receives: Dietary Supplement: Hard shell gelatin capsules |
| Acidophilus pearls | Experimental | * Encapsulated using patented process
* One capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days Receives: Dietary Supplement: Acidophilus pearls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal survival of probiotics
The investigators will measure survival of the probiotics in fecal samples.
Measured: Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19
Secondary outcomes (1)
GI symptoms
Change in GI symptoms using a weekly questionnaire.
Measured: Day 7-9 and day 10-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival of Probiotics During GI TransitStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Schwabe North America
- Responsible party
- Sponsor
- Investigators
- Volker Mai, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001610
- Sponsor's protocol ID
- IRB201300549
- Other IDs
- PS Project 00090915
- Status last verified
- Feb 2017
- First submitted
- 22 Nov 2013
- Last updated
- 8 Feb 2017
- 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 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Viability of LAB and Bifidobacteria From Acidophilus Pearls in Human Stool Samples
- ClinicalTrials.gov ID
- NCT02001610
- Acronym / sponsor ID
- IRB201300549
- Keywords
- microbiota, probiotics, fecal markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Schwabe North America
- Study start
- Mar 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 5 Dec 2013 (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.
Commercial probiotics can be delivered in numerous forms. The two most common delivery forms are similar to the two product formats to be tested. It has been demonstrated using in vitro testing that probiotic organisms that are unprotected from gastric exposure may not survive that exposure and therefore may not remain viable throughout the rest of the GIT. (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule will survive gastric exposure. It is anticipated that this difference in in vitro gastric survivability will translate to improved digestive tract survivability that can be demonstrated using fecal recovery techniques.
The commercial product to be tested in this clinical trial has been in the market for over 17 years. However, it is not known what effect this commercial product has on the commensal probiotic population in the gut and particularly in the lower bowel where much of probiotic benefits are believed to be largely realized. Also, it is not known what effect the commercial product has on the total commensal microbiota or fecal pH. While commercial probiotic products have been largely aimed at benefits related to improved health, they also have the potential to change overall gut microbiota (probiotics as well as all others) composition and activities. Learning what happens to the overall gut microbiota can be a helpful step in establishing the potential health benefits of the probiotic class of organisms in the test products.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hard shell gelatin capsules | Active comparator | Dietary Supplement: Hard shell gelatin capsules* Comparison delivery vehicle in the form of gelatin capsule * One capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days |
| Acidophilus pearls | Experimental | Dietary Supplement: Acidophilus pearls* Encapsulated using patented process * One capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult
- Regular and predictable bowel movement pattern
- Willing to disclose OTC/prescription medications and dietary supplements taken during the study
- Willing to sign comprehensive informed consent form
Key exclusion criteria (4 listed)
- Digestive disorders
- Use of prescribed medications that affect bowel function or microbiota (antibiotics, pain medications, laxatives)
- Use of dietary supplements/foods that can affect bowel function or microbiota
- Excessive alcohol use
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 |
|---|---|---|
| Acidophilus pearls* Acidophilus pearls are encapsulated using patented process * Subjects take one capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days | Dietary supplement | Acidophilus pearls |
| Hard shell gelatin capsules* Hard-shelled gelatin capsule with same microbial formulation as pearl supplement * Subjects consume one capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days | Dietary supplement | Hard shell gelatin capsules |
Primary outcome
Change in fecal survival of probiotics
Time frame: Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19
The investigators will measure survival of the probiotics in fecal samples.
1 secondary outcome
GI symptoms
Time frame: Day 7-9 and day 10-12
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 8 Feb 2017.
- 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.
Volker Mai, PhD 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 Acidophilus pearls and Hard shell gelatin capsules in people with Survival of Probiotics During GI Transit and GI Symptoms, 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 4 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 8 Feb 2017. 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. 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 fecal survival of probiotics (time frame: Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19). 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 8 Feb 2017.