Digestive IrregularityPhase 3PRIDENCT01203462
The PRIDE Study Probiotics on Regulation and Improving Digestive hEalth
A Phase 3 study testing Probiotic strain of Bifidobacterium and No Bifidobacterium in people with Digestive Irregularity and Digestive Discomfort, run by Georgetown University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of probiotic supplemented yogurt in reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two yogurts will be administered, one containing a specific strain of probiotic in the Bifidobacterium genus and the other without the probiotic… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Digestive Irregularity, Digestive Discomfort, History of Straining During Bowel Movements
- What is being tested?
- Probiotic strain of Bifidobacterium and No Bifidobacterium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jul 2011
- Phase
- Phase 3
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being female
- Ability to speak and write English or Spanish
- Willingness to refrain from specified probiotic supplements, during the 12 week trial (a list of prohibited products will be provided)
- Have access to refrigeration and phone
- Have a history of straining during bowel movements
- Have a history of lumpy or hard stools
Who cannot join
- Presence of an allergy or intolerance to any ingredients in yogurt
- Morbid obesity, defined as a BMI>40
- Having inflammatory bowel disease
- Having a history of malabsorption syndrome
- Immunodeficiency, such as HIV or currently receiving chemotherapy
- Consumption of any medications used to treat, prevent or cure diarrhea in the last month
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- Consumption of any medications used to treat, prevent or cure constipation in the last month
- Diabetes mellitus
- Thyroid disorders, including hypo- or hyperthyroidism
- History of gastric, small bowel or colonic resection
- Documented history of gastric emptying disorder
- Consumption of narcotics, antipsychotic medications, or verapamil in the last month
- Known pelvic outlet obstruction
- Antibiotic usage within 4 weeks of enrollment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Department of Family Medicine, Research Division
Washington D.C., District of Columbia, 20007
About this study
Official title: A Probiotic Double-blind Randomized Placebo Crossover Trial of Colonic Transit Time in Adult Females, The PRIDE Study The Study to Determine the Effects of Probiotics on Regulation and Improving Digestive hEalth
The purpose of this study is to determine the effect of probiotic supplemented yogurt in reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two yogurts will be administered, one containing a specific strain of probiotic in the Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved gastrointestinal comfort and quality of life compared to those receiving the non-probiotic supplemented yogurt.
- Conditions
- Digestive Irregularity, Digestive Discomfort, History of Straining During Bowel Movements, History of Hard or Lumpy Stools
- Being tested
- Probiotic strain of Bifidobacterium, No Bifidobacterium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic strain of BifidobacteriumOther
4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.
No BifidobacteriumOther
4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium supplemented yogurt | Experimental | Bifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus Receives: Other: Probiotic strain of Bifidobacterium |
| Placebo Yogurt | Placebo comparator | Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus Receives: Other: No Bifidobacterium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic Transit Time
Measured: 90 days
Secondary outcomes (10)
Frequency of bowel movements (daily)
Measured: 90 days
Stool consistency (daily)
Measured: 90 days
Well being as assessed by agreed upon quality of life instrument
Measured: 90 days
Dietary intake survey
Measured: 90 days
Tolerance
by questionnaire: e.g. bloating
Measured: 90 days
Rome criteria
Measured: 90 days
Bristol criteria
Measured: 90 days
Recovery of the probiotic in the faeces (quantitative measure)
Measured: 90 days
Bacterial composition of the fecal flora
Measured: 90 days
Adverse events
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive IrregularityStudies of the same condition, open and under way.
- More trials run by Georgetown 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Sponsor
- Investigators
- Dan Merenstein, MD, Principal investigator, Georgetown UniversityCaren Palese, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203462
- Sponsor's protocol ID
- 2010-402
- Acronym
- PRIDE
- Status last verified
- Dec 2012
- First submitted
- 15 Sep 2010
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Probiotic Double-blind Randomized Placebo Crossover Trial of Colonic Transit Time in Adult Females, The PRIDE Study The Study to Determine the Effects of Probiotics on Regulation and Improving Digestive hEalth
- ClinicalTrials.gov ID
- NCT01203462
- Acronym / sponsor ID
- PRIDE / 2010-402
- Conditions
- Digestive Irregularity, Digestive Discomfort, History of Straining During Bowel Movements, History of Hard or Lumpy Stools
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Sep 2010 (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 the effect of probiotic supplemented yogurt in reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two yogurts will be administered, one containing a specific strain of probiotic in the Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved gastrointestinal comfort and quality of life compared to those receiving the non-probiotic supplemented yogurt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium supplemented yogurt | Experimental | Other: Probiotic strain of BifidobacteriumBifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus |
| Placebo Yogurt | Placebo comparator | Other: No BifidobacteriumVanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being female
- Ability to speak and write English or Spanish
- Willingness to refrain from specified probiotic supplements, during the 12 week trial (a list of prohibited products will be provided)
- Have access to refrigeration and phone
- Have a history of straining during bowel movements
Key exclusion criteria (15 listed)
- Presence of an allergy or intolerance to any ingredients in yogurt
- Morbid obesity, defined as a BMI>40
- Having inflammatory bowel disease
- Having a history of malabsorption syndrome
- Immunodeficiency, such as HIV or currently receiving chemotherapy
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 strain of Bifidobacterium4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving. | Other | Bifidobacterium supplemented yogurt |
| No Bifidobacterium4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added. | Other | Placebo Yogurt |
Primary outcome
Colonic Transit Time
Time frame: 90 days
10 secondary outcomes
Frequency of bowel movements (daily)
Time frame: 90 days
Stool consistency (daily)
Time frame: 90 days
Well being as assessed by agreed upon quality of life instrument
Time frame: 90 days
Dietary intake survey
Time frame: 90 days
Tolerance
Time frame: 90 days
Rome criteria
Time frame: 90 days
Bristol criteria
Time frame: 90 days
Recovery of the probiotic in the faeces (quantitative measure)
Time frame: 90 days
Bacterial composition of the fecal flora
Time frame: 90 days
Adverse events
Time frame: 90 days
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 11 Feb 2013.
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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.
Dan Merenstein, MD principal investigator
Georgetown University
Caren Palese, MD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic strain of Bifidobacterium and No Bifidobacterium in people with Digestive Irregularity and Digestive Discomfort, run by Georgetown 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 15 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 11 Feb 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Colonic Transit Time (time frame: 90 days). 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 11 Feb 2013.