Delayed Transit TimePhase 1NCT01399996
Influence of a Delivery System on the Efficacy of a Probiotic Intervention
A Phase 1 study testing Yogurt smoothie without probiotic, Yogurt smoothie with probiotic added post fermentation and Yogurt smoothie with probiotic added pre-fermentation in people with Delayed Transit Time and Irregular Bowel Function, run by Penn State University at 1 site in United States.
Trial summary
In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Transit Time, Irregular Bowel Function
- What is being tested?
- Yogurt smoothie without probiotic, Yogurt smoothie with probiotic added post fermentation and Yogurt smoothie with probiotic added pre-fermentation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Aug 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Men and women
- 18-40 years of age
- Body mass index between 20 and 35 kg/m^2
- Persons with irregular bowel function as determined using the Rome III criteria (1) which is used to classify functional gastrointestinal disorders.
- Increased gastrointestinal transit time > 60 hours.
Who cannot join
- Smoking and/or use of other tobacco products
- Blood pressure greater than 140/90 mm Hg
- A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease and thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided).
- Lactation, pregnancy or desire to become pregnant during the study
- Use of cholesterol-lowering medication
- Refusal to discontinue intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, stanol/sterol supplemented foods
Show all 20Show fewer
- Refusal to discontinue probiotics,nutritional supplements, herbs or vitamins
- Vegetarianism/Veganism
- Lactose intolerance
- Clinical diagnosis of Inflammatory Bowel Disease (IBD), e.g. Crohn's Disease or ulcerative colitis
- Excessive alcohol consumption (> 14 standard drinks per week)
- Chronic use of anti-inflammatory medications (unless able to discontinue)
- Individuals taking stool softeners or enemas on a regular basis.
- Allergy to polyvinyl chloride (PVC) or any other type of plastic
- Individuals with a bowel transit time of < 60 hours at time of screening
- Individuals with swallowing disorders or dysphagia to food or pills
- Suspected strictures, fistulas, or physiological GI Obstruction
- GI surgery within the past three months
- Refusal to agree to give blood or plasma for the length of the study.
- Note: If a participant experiences a delay in passing the capsule (beyond five days) they will be treated accordingly and excluded from future participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human volunteers. In addition to providing information about the relative efficacy of the delivery vehicles on probiotic function it will provide novel information about the influence of the yogurt smoothie alone (control) on all the parameters measured.
Read the detailed description
Probiotics (health-promoting bacteria) are often considered "functional ingredients" that act independently of the matrix used to deliver them to the human host. This thinking ignores the impact the delivery matrix (food or dietary supplement) may have on both the physiology of the probiotic organism and on the human host and is likely not true.
Historically the most common "probiotic foods" have been fermented dairy products, particularly yogurts. Since yogurts are commonly understood to contain live "good" bacteria they are well accepted by consumers. However, increasingly over the last decade, probiotics are being added to non-dairy-based foods (juice, chocolate, cookies, etc) or consumed as supplements (tablets/capsules). While this expands the options for people to obtain probiotic organism, it is not clear whether probiotics delivered in these products are as efficacious as when delivered in a dairy food. In fact, the buffering capacity and nutrient composition of milk products may directly influence efficacy of the probiotic by increasing survival during passage through the gastrointestinal tract (GIT) and by modifying the physiology of the probiotic organism. In addition, fermentation products produced by the probiotic during manufacture of yogurt may also have an influence on the efficacy of probiotic bacteria.
Our hypotheses are:
- The vehicle used to deliver probiotic bacteria into the body influences the performance of the probiotic in vivo. Specifically, consumption of yogurt-based smoothie containing probiotic bacteria will result in greater decrease in fecal transit time, and have a greater effect on the composition of the fecal microbiota and on markers of immune status than the same probiotic bacteria delivered at the same level in the form of a dietary supplement (tablet).
- Timing of the addition of probiotic organism to the yogurt smoothie (pre or post fermentation) will not change the efficacy of the probiotic with respect to the outcomes being assessed.
- Conditions
- Delayed Transit Time, Irregular Bowel Function
- Being tested
- Yogurt smoothie without probiotic, Yogurt smoothie with probiotic added post fermentation, Yogurt smoothie with probiotic added pre-fermentation, A capsule containing the probiotic
- Keywords
- probiotic, microbiota, transit time, immunity, immune function, constipation, bowel function
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogurt smoothie without probioticDietary supplement
Also called Yogurt
A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
Yogurt smoothie with probiotic added post fermentationDietary supplement
Also called Yogurt with probiotic
A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
Yogurt smoothie with probiotic added pre-fermentationDietary supplement
Also called Yogurt with probiotic
A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
A capsule containing the probioticDietary supplement
Also called Probiotic capsule
A capsule taken daily will provide between 10x^y9 and 10x^y10 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
| Study group | Role | What they receive |
|---|---|---|
| Yogurt smoothie without probiotic. | Placebo comparator | Not described Receives: Dietary Supplement: Yogurt smoothie without probiotic |
| Probiotic added post fermentation. | Experimental | Not described Receives: Dietary Supplement: Yogurt smoothie with probiotic added post fermentation |
| Probiotic added pre-fermentation. | Experimental | Not described Receives: Dietary Supplement: Yogurt smoothie with probiotic added pre-fermentation |
| A capsule containing the probiotic. | Experimental | Not described Receives: Dietary Supplement: A capsule containing the probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal transit time
Gastrointestinal transit time is the amount of time it takes for food to travel through the digestive tract to be excreted. It will be measured using the SmartPill wireless motility capsule.
Measured: Weeks 4, 10, 16, 22
Secondary outcomes (2)
Change from baseline in the fecal microbiota profile at 4 weeks following each of the 4 interventions and 1 free living period
Measured: Weeks 4, 10, 16, 22 and 28
Change from baseline in immune status at 4 weeks following each of the 4 interventions and 1 free living period
Measured: Weeks 4, 10, 16, 22, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startApr 2012
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Delayed Transit TimeStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399996
- Sponsor's protocol ID
- PKE PROBIOTIC
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2011
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Drossman DA, Dumitrascu DL. Rome III: New standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis. 2006 Sep;15(3):237-41.
PubMed 17013448Ba Z, Lee Y, Meng H, Kris-Etherton PM, Rogers CJ, Lewis ZT, Mills DA, Furumoto EJ, Rolon ML, Fleming JA, Roberts RF. Matrix Effects on the Delivery Efficacy of Bifidobacterium animalis subsp. lactis BB-12 on Fecal Microbiota, Gut Transit Time, and Short-Chain Fatty Acids in Healthy Young Adults. mSphere. 2021 Aug 25;6(4):e0008421. doi: 10.1128/mSphere.00084-21. Epub 2021 Jul 7.
PubMed 34232082Lee Y, Ba Z, Roberts RF, Rogers CJ, Fleming JA, Meng H, Furumoto EJ, Kris-Etherton PM. Effects of Bifidobacterium animalis subsp. lactis BB-12(R) on the lipid/lipoprotein profile and short chain fatty acids in healthy young adults: a randomized controlled trial. Nutr J. 2017 Jun 29;16(1):39. doi: 10.1186/s12937-017-0261-6.
PubMed 28662676Meng H, Lee Y, Ba Z, Peng J, Lin J, Boyer AS, Fleming JA, Furumoto EJ, Roberts RF, Kris-Etherton PM, Rogers CJ. Consumption of Bifidobacterium animalis subsp. lactis BB-12 impacts upper respiratory tract infection and the function of NK and T cells in healthy adults. Mol Nutr Food Res. 2016 May;60(5):1161-71. doi: 10.1002/mnfr.201500665. Epub 2016 Mar 1.
PubMed 26821116
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Delivery System on the Efficacy of a Probiotic Intervention
- ClinicalTrials.gov ID
- NCT01399996
- Acronym / sponsor ID
- PKE PROBIOTIC
- Conditions
- Delayed Transit Time, Irregular Bowel Function
- Keywords
- probiotic, microbiota, transit time, immunity, immune function, constipation, bowel function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Jul 2011 (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.
In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human volunteers. In addition to providing information about the relative efficacy of the delivery vehicles on probiotic function it will provide novel information about the influence of the yogurt smoothie alone (control) on all the parameters measured.
Detailed description
Probiotics (health-promoting bacteria) are often considered "functional ingredients" that act independently of the matrix used to deliver them to the human host. This thinking ignores the impact the delivery matrix (food or dietary supplement) may have on both the physiology of the probiotic organism and on the human host and is likely not true.
Historically the most common "probiotic foods" have been fermented dairy products, particularly yogurts. Since yogurts are commonly understood to contain live "good" bacteria they are well accepted by consumers. However, increasingly over the last decade, probiotics are being added to non-dairy-based foods (juice, chocolate, cookies, etc) or consumed as supplements (tablets/capsules). While this expands the options for people to obtain probiotic organism, it is not clear whether probiotics delivered in these products are as efficacious as when delivered in a dairy food. In fact, the buffering capacity and nutrient composition of milk products may directly influence efficacy of the probiotic by increasing survival during passage through the gastrointestinal tract (GIT) and by modifying the physiology of the probiotic organism. In addition, fermentation products produced by the probiotic during manufacture of yogurt may also have an influence on the efficacy of probiotic bacteria.
Our hypotheses are:
- The vehicle used to deliver probiotic bacteria into the body influences the performance of the probiotic in vivo. Specifically, consumption of yogurt-based smoothie containing probiotic bacteria will result in greater decrease in fecal transit time, and have a greater effect on the composition of the fecal microbiota and on markers of immune status than the same probiotic bacteria delivered at the same level in the form of a dietary supplement (tablet).
- Timing of the addition of probiotic organism to the yogurt smoothie (pre or post fermentation) will not change the efficacy of the probiotic with respect to the outcomes being assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Yogurt smoothie without probiotic. | Placebo comparator | Dietary Supplement: Yogurt smoothie without probiotic |
| Probiotic added post fermentation. | Experimental | Dietary Supplement: Yogurt smoothie with probiotic added post fermentation |
| Probiotic added pre-fermentation. | Experimental | Dietary Supplement: Yogurt smoothie with probiotic added pre-fermentation |
| A capsule containing the probiotic. | Experimental | Dietary Supplement: A capsule containing the probiotic |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Generally healthy
- Men and women
- 18-40 years of age
- Body mass index between 20 and 35 kg/m^2
- Persons with irregular bowel function as determined using the Rome III criteria (1) which is used to classify functional gastrointestinal disorders.
Key exclusion criteria (20 listed)
- Smoking and/or use of other tobacco products
- Blood pressure greater than 140/90 mm Hg
- A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease and thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided).
- Lactation, pregnancy or desire to become pregnant during the study
- Use of cholesterol-lowering medication
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 |
|---|---|---|
| Yogurt smoothie without probioticAlso: YogurtA daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12). | Dietary supplement | Yogurt smoothie without probiotic. |
| Yogurt smoothie with probiotic added post fermentationAlso: Yogurt with probioticA daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12). | Dietary supplement | Probiotic added post fermentation. |
| Yogurt smoothie with probiotic added pre-fermentationAlso: Yogurt with probioticA daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12). | Dietary supplement | Probiotic added pre-fermentation. |
| A capsule containing the probioticAlso: Probiotic capsuleA capsule taken daily will provide between 10x^y9 and 10x^y10 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12). | Dietary supplement | A capsule containing the probiotic. |
Primary outcome
Gastrointestinal transit time
Time frame: Weeks 4, 10, 16, 22
Gastrointestinal transit time is the amount of time it takes for food to travel through the digestive tract to be excreted. It will be measured using the SmartPill wireless motility capsule.
2 secondary outcomes
Change from baseline in the fecal microbiota profile at 4 weeks following each of the 4 interventions and 1 free living period
Time frame: Weeks 4, 10, 16, 22 and 28
Change from baseline in immune status at 4 weeks following each of the 4 interventions and 1 free living period
Time frame: Weeks 4, 10, 16, 22, 28
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 Aug 2023.
- Background: PubMed 17013448Drossman DA, Dumitrascu DL. Rome III: New standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis. 2006 Sep;15(3):237-41.
- Derived from this study: PubMed 34232082Ba Z, Lee Y, Meng H, Kris-Etherton PM, Rogers CJ, Lewis ZT, Mills DA, Furumoto EJ, Rolon ML, Fleming JA, Roberts RF. Matrix Effects on the Delivery Efficacy of Bifidobacterium animalis subsp. lactis BB-12 on Fecal Microbiota, Gut Transit Time, and Short-Chain Fatty Acids in Healthy Young Adults. mSphere. 2021 Aug 25;6(4):e0008421. doi: 10.1128/mSphere.00084-21. Epub 2021 Jul 7.
- Derived from this study: PubMed 28662676Lee Y, Ba Z, Roberts RF, Rogers CJ, Fleming JA, Meng H, Furumoto EJ, Kris-Etherton PM. Effects of Bifidobacterium animalis subsp. lactis BB-12(R) on the lipid/lipoprotein profile and short chain fatty acids in healthy young adults: a randomized controlled trial. Nutr J. 2017 Jun 29;16(1):39. doi: 10.1186/s12937-017-0261-6.
- Derived from this study: PubMed 26821116Meng H, Lee Y, Ba Z, Peng J, Lin J, Boyer AS, Fleming JA, Furumoto EJ, Roberts RF, Kris-Etherton PM, Rogers CJ. Consumption of Bifidobacterium animalis subsp. lactis BB-12 impacts upper respiratory tract infection and the function of NK and T cells in healthy adults. Mol Nutr Food Res. 2016 May;60(5):1161-71. doi: 10.1002/mnfr.201500665. Epub 2016 Mar 1.
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.
Penny M Kris-Etherton, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Yogurt smoothie without probiotic, Yogurt smoothie with probiotic added post fermentation and Yogurt smoothie with probiotic added pre-fermentation in people with Delayed Transit Time and Irregular Bowel Function, run by Penn State University 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 20 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 Aug 2023. 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?
Gastrointestinal transit time (time frame: Weeks 4, 10, 16, 22). 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 NCT01399996, which also lists 4 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 21 Aug 2023.