PainNCT00618904
Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating
A study testing Probiotics - Lactobacillus and bifidobacterium in people with Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Probiotics - Lactobacillus and bifidobacterium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is 18 to 75 years old.
- The subject is an ambulatory outpatient.
- The subject has IBS, or functional diarrhea, or functional bloating according to the Rome II criteria for functional GI disorders.
- The subject has the above symptoms for at least two weeks, despite current 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 bloating we will use the Rome II definition "a feeling of abdominal fullness or bloating".
- Subject must have had a colonoscopy if age > 50y/o.
- The subject's symptoms are mild to moderate symptoms 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
Who cannot join
- 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, symptomatic cholelithiasis).
- The subject has severe FBD related symptoms at baseline.
- The subject has a serious, unstable medical condition.
- 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.
Show all 14Show fewer
- 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 during the last 8 weeks. (If the subject was on antibiotic treatment, a washout period of 8 weeks is required).
- The subject had previous significant intestinal surgery.
- The subject is pregnant or lactating, or unwilling to maintain effective contraception during course of study
- 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 Probiotic Bacteria in Subjects With Irritable Bowel Syndrome (IBS), Functional Diarrhea, or Functional Bloating
To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.
Read the detailed description
Functional Bowel disorders (FBD) including Irritable Bowel Syndrome (IBS) are characterized by a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities. IBS is the most common functional gastrointestinal disorder, affecting 8% to 23% of adults in the western world and accounts for 12% of primary care and 28% of gastroenterological practice visits yearly. The pathophysiology of IBS is not completely understood and currently available drug treatments for IBS are very limited (1-2). The apparent success of the use of probiotics in several gut disorders (e.g., IBD) together with the greater understanding of the role of inflammation and intestinal microflora in the pathophysiology of IBS has led to increased interest in use of probiotics in patients with IBS (3). The data on the use of probiotic in IBS is limited. However, few reported studies show encouraging results and suggests some symptomatic response and parallel improvement in quality of life (3-4). A controlled, double-blind study, randomized 20 patients with IBS to L. plantarum 299v or placebo for 4 weeks concluded that L. plantarum decreased abdominal pain and tended to normalize stool frequency in constipated patients (5). On the other hand, Lactobacillus casei GG, was found to improve stool consistency in patients with IBS and diarrhea (6). A recent randomized controlled trial using the probiotic formulation VSL#3 improved abdominal bloating in patients with diarrhea-predominant IBS. However, no differences in gastrointestinal transit measurement, bowel function scores or satisfactory global symptom relief were shown (7). The inconsistent findings of these clinical studies may be accounted to the differences in probiotics composition and the heterogeneous and multifactorial nature of the disorder. However, these studies indicate a potential relationship between probiotics therapy and functional abdominal symptoms and suggesting that the possible role of probiotics in the treatment of IBS deserves further study.
- Conditions
- Pain
- Being tested
- Probiotics - Lactobacillus and bifidobacterium, Placebo
- Keywords
- Probiotics, Functional 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.
Probiotics - Lactobacillus and bifidobacteriumDietary supplement
Probiotics administered bid for 6 weeks.
PlaceboDietary supplement
Placebo administered bid for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Probiotic containing Lactobacillus and Bifidobacterium Receives: Dietary Supplement: Probiotics - Lactobacillus and bifidobacterium |
| 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 primary outcome measure will be the global relief of GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.
Secondary outcomes (1)
Assess the improvement of specific functional bowel disorders (FBD) related symptoms and Health Related Quality of Life (HRQOL).
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 startDec 2005
- Primary completionFeb 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Danisco
- Responsible party
- Sponsor
- Investigators
- Yehuda Ringel, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618904
- Sponsor's protocol ID
- 04-1704
- Status last verified
- Jul 2013
- First submitted
- 7 Feb 2008
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ringel-Kulka T, Palsson OS, Maier D, Carroll I, Galanko JA, Leyer G, Ringel Y. Probiotic bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 versus placebo for the symptoms of bloating in patients with functional bowel disorders: a double-blind study. J Clin Gastroenterol. 2011 Jul;45(6):518-25. doi: 10.1097/MCG.0b013e31820ca4d6.
PubMed 21436726
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Probiotic Bacteria in Subjects With Irritable Bowel Syndrome (IBS), Functional Diarrhea, or Functional Bloating
- ClinicalTrials.gov ID
- NCT00618904
- Acronym / sponsor ID
- 04-1704
- Conditions
- Pain
- Keywords
- Probiotics, Functional Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Danisco
- Study start
- Dec 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Sep 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.
To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.
Detailed description
Functional Bowel disorders (FBD) including Irritable Bowel Syndrome (IBS) are characterized by a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities. IBS is the most common functional gastrointestinal disorder, affecting 8% to 23% of adults in the western world and accounts for 12% of primary care and 28% of gastroenterological practice visits yearly. The pathophysiology of IBS is not completely understood and currently available drug treatments for IBS are very limited (1-2). The apparent success of the use of probiotics in several gut disorders (e.g., IBD) together with the greater understanding of the role of inflammation and intestinal microflora in the pathophysiology of IBS has led to increased interest in use of probiotics in patients with IBS (3). The data on the use of probiotic in IBS is limited. However, few reported studies show encouraging results and suggests some symptomatic response and parallel improvement in quality of life (3-4). A controlled, double-blind study, randomized 20 patients with IBS to L. plantarum 299v or placebo for 4 weeks concluded that L. plantarum decreased abdominal pain and tended to normalize stool frequency in constipated patients (5). On the other hand, Lactobacillus casei GG, was found to improve stool consistency in patients with IBS and diarrhea (6). A recent randomized controlled trial using the probiotic formulation VSL#3 improved abdominal bloating in patients with diarrhea-predominant IBS. However, no differences in gastrointestinal transit measurement, bowel function scores or satisfactory global symptom relief were shown (7). The inconsistent findings of these clinical studies may be accounted to the differences in probiotics composition and the heterogeneous and multifactorial nature of the disorder. However, these studies indicate a potential relationship between probiotics therapy and functional abdominal symptoms and suggesting that the possible role of probiotics in the treatment of IBS deserves further study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Probiotics - Lactobacillus and bifidobacteriumProbiotic containing Lactobacillus and Bifidobacterium |
| 2 | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is 18 to 75 years old.
- The subject is an ambulatory outpatient.
- The subject has IBS, or functional diarrhea, or functional bloating according to the Rome II criteria for functional GI disorders.
- The subject has the above symptoms for at least two weeks, despite current 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 bloating we will use the Rome II definition "a feeling of abdominal fullness or bloating".
- Subject must have had a colonoscopy if age > 50y/o.
Key exclusion criteria (14 listed)
- 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, symptomatic cholelithiasis).
- The subject has severe FBD related symptoms at baseline.
- The subject has a serious, unstable medical condition.
- The subject has insulin-dependent Diabetes Mellitus.
- The subject had a major psychiatric diagnosis or a suicide attempt within the last two years.
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 |
|---|---|---|
| Probiotics - Lactobacillus and bifidobacteriumProbiotics administered bid for 6 weeks. | Dietary supplement | 1 |
| PlaceboPlacebo administered bid for 6 weeks. | Dietary supplement | 2 |
Primary outcome
The primary outcome measure will be the global relief of GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.
1 secondary outcome
Assess the improvement of specific functional bowel disorders (FBD) related symptoms and Health Related Quality of Life (HRQOL).
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 9 Jul 2013.
- Derived from this study: PubMed 21436726Ringel-Kulka T, Palsson OS, Maier D, Carroll I, Galanko JA, Leyer G, Ringel Y. Probiotic bacteria Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07 versus placebo for the symptoms of bloating in patients with functional bowel disorders: a double-blind study. J Clin Gastroenterol. 2011 Jul;45(6):518-25. doi: 10.1097/MCG.0b013e31820ca4d6.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 Probiotics - Lactobacillus and bifidobacterium in people with Pain, run by University of North Carolina, Chapel Hill 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 14 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 9 Jul 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.
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 primary outcome measure will be the global relief of GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.. 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 NCT00618904, 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 9 Jul 2013.