PainNCT00618488
Efficacy of Yogurt Containing BB12 in Subjects With GI Symptoms
A study testing Probiotic BB12 - Bifidobacterium lactis in people with Pain, run by University of North Carolina at 1 site in United States.
Trial summary
The purpose of this study is to determine if probiotics bacteria, specifically bifidobacterium lactis (BB12) improve gastrointestinal symptoms in subjects with functional gastrointestinal symptoms (i.e., non-patients IBS/functional bowel disorders). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Probiotic BB12 - Bifidobacterium lactis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Nov 2007
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is 18 - 70 y/o.
- The subject has any functional GI symptoms that are related to IBS, functional diarrhea, functional constipation, or functional bloating according to the Rome II criteria for functional GI disorders. The subject has the above symptoms for at least two weeks (i.e., active symptoms on enrollment). The subject has not been seen by a medical care provider for these symptoms in the 10 months and is not taking prescribed medications for these symptoms. Over the counter (OTC) medications are allowed as long as the subject is still symptomatic despite current OTC therapy.
- For diarrhea we will use the definition of a mean of >2 bowel movements per day, or a mean score of > 4 on the Bristol Stool Form Scale per week.
- For constipation we will use the definition of a mean of <3 bowel movements per week or a need for significant straining for a bowel movement.
- The subject's symptoms are mild to moderate in severity. Symptoms severity will be assessed at baseline and at the end of the 2-weeks screening period to determine eligibility prior randomization. Severity of bowel symptoms will be determined using the Francis Whorwell IBS severity scale: Mild <175, Moderate 175-300, Severe >300
- Subject must have had a normal colonoscopy within the last 3 years if age >50y/o.
- Subjects' initial evaluation at screening visit including medical history, physical examination, and laboratory tests are unrevealing i.e., do not show abnormalities that require further investigation.
Who cannot join
- The subject saw a physician for your functional bowel symptoms in the last 10 months
- The subject has taken prescribed medications for your functional bowel symptoms
- The subject has inflammation or structural abnormality of the digestive tract [e.g. inflammatory bowel disease (IBD), duodenal ulcer (DU) or gastric ulcer (GU), obstruction, or symptomatic cholelithiasis].
- The subject has severe FBD symptoms at baseline.
- The subject carries a medical diagnosis of FBD and has seen a medical care provider and take prescribed medications for their GI symptoms. Patients who did not see a medical care provider for these symptoms for more than 10 months and are not taking prescribed medications for their GI symptoms are eligible.
- The subject has a serious, unstable medical condition.
Show all 17Show fewer
- The subject has insulin-dependent Diabetes Mellitus.
- The subject had a major psychiatric diagnosis or a suicide attempt within the last two years.
- The subject has a history of alcohol or substance abuse within two years.
- The subject has abnormal laboratory results (including ALT or AST > than 2.5 times normal, serum creatinine >2.0mg/dl, untreated abnormal TSH value)
- The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer).
- The subject has been diagnosed with lactase deficiency and this can explain their symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet.)
- The subject has participated in a drug study within the last 21 days.
- The subject received antibiotic treatment or intentionally consumes probiotic products during the last 6 weeks. (If the subject was on antibiotic or probiotics treatment, a washout period of 6 weeks is required).
- The subject had previous significant gastric or intestinal surgery.
- Patient is pregnant or lactating due to possible effects of hormonal changes during pregnancy on GI functions and/or functional GI symptoms.
- The subject is predisposed to infection (i.e. their immune system is compromised, they have rheumatic heart disease, an artificial valve, history of bacterial endocarditis, or an active bacterial disease).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7080
About this study
Official title: Clinical Efficacy of Yogurt Containing Bifidobacterium Lactis (BB12) in Subjects With Functional Gastrointestinal Symptoms
The purpose of this study is to determine if probiotics bacteria, specifically bifidobacterium lactis (BB12) improve gastrointestinal symptoms in subjects with functional gastrointestinal symptoms (i.e., non-patients IBS/functional bowel disorders).
Read the detailed description
The apparent success of the use of probiotics in several gut disorders (e.g., IBD and rotavirus diarrhea) together with the greater understanding of the role of inflammation and intestinal microflora in the pathophysiology of functional bowel disorders has led to increased interest in use of probiotics in patients with these symptoms. The data on the use of probiotic in certain functional GI disorders (e.g., IBS, bloating, diarrhea) is limited but several reported studies show encouraging results and suggest some symptomatic response and parallel improvement in quality of life. Functional Bowel Disorders (FBD) - According to the Rome II criteria FBD refer to symptoms attributed to the mid or lower GI tract. FBD include several clinical subgroups including irritable bowel syndrome (IBS), functional diarrhea, functional constipation, functional abdominal bloating, and an unspecified group. This study will examine 'Non-Patients IBS,' these are people who have functional gastrointestinal (GI) symptoms but do not sought out medical care for their GI symptoms and therefore they are referred to as 'Non-patients'. This study will investigate the overall effect of probiotic bacteria (BB12) on GI symptoms in non-patients subjects with functional bowel symptoms (FBS).
- Conditions
- Pain
- Being tested
- Probiotic BB12 - Bifidobacterium lactis, Placebo
- Keywords
- Probiotics, BB12, Gastrointestinal Symptoms
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic BB12 - Bifidobacterium lactisDietary supplement
Bifidobacterium lactis (3.1 oz yogurt) administered once a day for 6 weeks
PlaceboDietary supplement
Placebo administered once a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bifidobacterium lactis Receives: Dietary Supplement: Probiotic BB12 - Bifidobacterium lactis |
| 2 | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The global relief of functional GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.
Measured: March 2008
Secondary outcomes (1)
The satisfaction with treatment as assessed by Satisfaction Survey.
Measured: March 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startFeb 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Investigators
- Yehuda Ringel, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618488
- Sponsor's protocol ID
- 06-0922
- Status last verified
- Feb 2008
- First submitted
- 7 Feb 2008
- Last updated
- 20 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Yogurt Containing Bifidobacterium Lactis (BB12) in Subjects With Functional Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT00618488
- Acronym / sponsor ID
- 06-0922
- Conditions
- Pain
- Keywords
- Probiotics, BB12, Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of North CarolinaUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- Feb 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 20 Feb 2008 (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 probiotics bacteria, specifically bifidobacterium lactis (BB12) improve gastrointestinal symptoms in subjects with functional gastrointestinal symptoms (i.e., non-patients IBS/functional bowel disorders).
Detailed description
The apparent success of the use of probiotics in several gut disorders (e.g., IBD and rotavirus diarrhea) together with the greater understanding of the role of inflammation and intestinal microflora in the pathophysiology of functional bowel disorders has led to increased interest in use of probiotics in patients with these symptoms. The data on the use of probiotic in certain functional GI disorders (e.g., IBS, bloating, diarrhea) is limited but several reported studies show encouraging results and suggest some symptomatic response and parallel improvement in quality of life. Functional Bowel Disorders (FBD) - According to the Rome II criteria FBD refer to symptoms attributed to the mid or lower GI tract. FBD include several clinical subgroups including irritable bowel syndrome (IBS), functional diarrhea, functional constipation, functional abdominal bloating, and an unspecified group. This study will examine 'Non-Patients IBS,' these are people who have functional gastrointestinal (GI) symptoms but do not sought out medical care for their GI symptoms and therefore they are referred to as 'Non-patients'. This study will investigate the overall effect of probiotic bacteria (BB12) on GI symptoms in non-patients subjects with functional bowel symptoms (FBS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Probiotic BB12 - Bifidobacterium lactisBifidobacterium lactis |
| 2 | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is 18 - 70 y/o.
- The subject has any functional GI symptoms that are related to IBS, functional diarrhea, functional constipation, or functional bloating according to the Rome II criteria for functional GI disorders. The subject has the above symptoms for at least two weeks (i.e., active symptoms on enrollment). The subject has not been seen by a medical care provider for these symptoms in the 10 months and is not taking prescribed medications for these symptoms. Over the counter (OTC) medications are allowed as long as the subject is still symptomatic despite current OTC therapy.
- For diarrhea we will use the definition of a mean of >2 bowel movements per day, or a mean score of > 4 on the Bristol Stool Form Scale per week.
- For constipation we will use the definition of a mean of <3 bowel movements per week or a need for significant straining for a bowel movement.
- The subject's symptoms are mild to moderate in severity. Symptoms severity will be assessed at baseline and at the end of the 2-weeks screening period to determine eligibility prior randomization. Severity of bowel symptoms will be determined using the Francis Whorwell IBS severity scale: Mild <175, Moderate 175-300, Severe >300
Key exclusion criteria (17 listed)
- The subject saw a physician for your functional bowel symptoms in the last 10 months
- The subject has taken prescribed medications for your functional bowel symptoms
- The subject has inflammation or structural abnormality of the digestive tract [e.g. inflammatory bowel disease (IBD), duodenal ulcer (DU) or gastric ulcer (GU), obstruction, or symptomatic cholelithiasis].
- The subject has severe FBD symptoms at baseline.
- The subject carries a medical diagnosis of FBD and has seen a medical care provider and take prescribed medications for their GI symptoms. Patients who did not see a medical care provider for these symptoms for more than 10 months and are not taking prescribed medications for their GI symptoms are eligible.
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 BB12 - Bifidobacterium lactisBifidobacterium lactis (3.1 oz yogurt) administered once a day for 6 weeks | Dietary supplement | 1 |
| PlaceboPlacebo administered once a day for 6 weeks | Dietary supplement | 2 |
Primary outcome
The global relief of functional GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.
Time frame: March 2008
1 secondary outcome
The satisfaction with treatment as assessed by Satisfaction Survey.
Time frame: March 2008
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 20 Feb 2008.
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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.
Yehuda Ringel, MD principal investigator
University of North Carolina, Chapel Hill
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 BB12 - Bifidobacterium lactis in people with Pain, run by University of North Carolina 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 7 inclusion and 17 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 20 Feb 2008. 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?
The global relief of functional GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms. (time frame: March 2008). 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 20 Feb 2008.