Abdominal PainNCT01064661
Pilot Study Studying Physiological Effects of Probiotic Pills in Patients With Abdominal Pain/Discomfort and Bloating
A study testing Single probiotic arm of L-NCFM alone and Blend probiotic arm of L-NCFM and B-LBi07 in people with Abdominal Pain and Abdominal Discomfort, run by University of North Carolina, Chapel Hill.
Trial summary
We are conducting a study to learn if probiotics, which are live bacteria found in food like yogurt and cheese, will improve symptoms of abdominal pain. Individuals participating in this study will take probiotic pills to see if this affects the expression of certain pain receptors in the intestines that relate to… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Abdominal Pain, Abdominal Discomfort, Bloating
- What is being tested?
- Single probiotic arm of L-NCFM alone and Blend probiotic arm of L-NCFM and B-LBi07
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2012
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An informed consent has been signed.
- The subject is a female.
- The subject is 18 - 70 years old.
- Active symptoms of abdominal pain or discomfort. Other functional bowel disorders including IBS, functional abdominal pain, and functional bloating are also allowed. For all functional bowel disorders we will use the definition provided by the Rome III criteria.
- The subject's abdominal pain is of mild to moderate in severity. Severity of abdominal pain will also be determined using 10 point likert scale.
- Subjects > 50 years old must have had a screening colonoscopy with a normal report in the past 5 years - per subject report at time of phone screen. Removal of polyps and hemorrhoids are acceptable.
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, or symptomatic cholelithiasis.
- The subject has severe abdominal pain symptoms at baseline.
- The subject has a serious, unstable medical condition, such as lung disease, uncontrolled blood pressure, uncontrolled thyroid function, a physical or medical disability or an advanced 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.
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- 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 had previous significant gastric or intestinal surgery (except appendectomy and gall bladder surgery).
- Subject is pregnant or lactating, or planning to become pregnant. (A urine pregnancy test will be performed on female subjects prior to the flexible sigmoidoscopy procedure. Acceptable forms of birth control include oral contraceptives, double barrier method, and IUD cover and must be practiced from the time of enrollment until the time of release from the 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)
- The subject received antibiotic treatment or was intentionally consuming probiotic supplementation on a daily basis during the last 4 weeks. If a subject uses antibiotics or probiotics, a 4 weeks washout period is required prior to enrollment.
- The subject has taken medication for pain relief or anti-inflammatory medications (e.g., aspirin, NSAID, or steroids) in the last 10 days. If a subject uses pain medication or anti-inflammatory medications, a 10 days washout period is required prior to enrollment.
About this study
Official title: Physiological Effects of Probiotic Bacteria Lactobacillus Acidophilus NCFM Alone Versus a Combination With Bifidobacterium Lactids - LBi07 in Patients With Mild to Moderate Abdominal Pain/Discomfort and Bloating
We are conducting a study to learn if probiotics, which are live bacteria found in food like yogurt and cheese, will improve symptoms of abdominal pain. Individuals participating in this study will take probiotic pills to see if this affects the expression of certain pain receptors in the intestines that relate to pain sensation. Biopsies will be taken from the colon before subjects take the probiotic pills. Subjects will then be given one of two different types of probiotic pills to take for 3-4 weeks. After taking the supplements, more biopsies will be collected to see if any changes have taken places. This study requires one screening visit and two clinic visits to UNC hospital. Subjects will also complete daily diary cards for 2 weeks during the study to record their symptoms and also collect 2 stool samples.
Read the detailed description
The purpose of this study is to determine if probiotic bacteria, specifically Lactobacillus and Bifidobacterium, have an effect on pain receptors in the colon. Data from animal studies suggest that daily consumption of probiotic bacteria can increase expression of specific receptors in the intestinal mucosa in mice and that these mucosal effects are associated with decrease in intestinal pain sensation. We are interested to see if this is true in humans as well.
Probiotics are live bacteria, which can be found in certain foods like yogurt or cheese prepared with active cultures. The use of probiotics has been shown to be successful in several intestinal disorders, including chronic inflammatory bowel disease (IBD), childhood diarrhea (rotavirus infection), and travelers' diarrhea. This has led to increased interest in their use in patients with symptoms of abdominal pain or discomfort. Although, the data on the use of probiotics in bloating is limited, several reported studies show encouraging results and suggest a symptomatic response and parallel improvement in quality of life.
Probiotics are regarded by the US Food and Drug Administration (FDA) as dietary supplements. They do not require approval by the FDA or any government agency prior to marketing however they are subjected to the FDA jurisdiction regarding their safety, labeling, and health statements. Probiotics can be provided in various forms including food (such as yogurt) or in the format of pills, tablets, caps, and liquids. In this study they will be given in a pill form.
You are being asked to participate in this study because you are currently experiencing abdominal pain or discomfort in your abdomen and you have a functional bowel disorder. In order to determine if these probiotics have an effect, you will be asked to either take a Bifidobacterium probiotic or a blend of Bifidobacterium plus Lactobacillus probiotic. You will be asked to undergo an un-prepped, un-sedated flexible sigmoidoscopy both before your treatment course and after your treatment course. Biopsy samples will be taken during this procedure to analyze certain pain receptor levels, comparing differences between the two treatments of probiotics, and differences in receptors before after treatment. We may use this data for future research in understanding the probiotic function in the gut. We may also perform genetic testing on these specimens in order to look for relationships between genes, the environment, and people's habits or diet, and different diseases. All remaining samples will be stored for-as-yet-unknown tests.
Please note that in order to participate in this study the separate storage consent form is non-optional and must be signed allowing long term storage of stool samples.
- Being tested
- Single probiotic arm of L-NCFM alone, Blend probiotic arm of L-NCFM and B-LBi07
- Keywords
- Probiotics, abdominal pain, abdominal discomfort, bloating, Functional Bowel Disorders
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single probiotic arm of L-NCFM aloneDietary supplement
Also called Lactobacillus Acidophilus NCFM
Single probiotic of L-NCFM alone pills BID (2x10^10 cfu total bacteria per day)
Blend probiotic arm of L-NCFM and B-LBi07Dietary supplement
Also called Lactobacillus Acidophilus NCFM, Bifidobacterium Lactids - LBi07
Blend probiotic arm of L-NCFM and B-LBi07 pills BID (2x10^10 cfu total bacteria per day)
| Study group | Role | What they receive |
|---|---|---|
| Blend probiotic of L-NCFM and B-LBi07 | Active comparator | Blend probiotic pills of L-NCFM and B-LBi07 BID (2x10^10 cfu total bacteria per day) Receives: Dietary Supplement: Blend probiotic arm of L-NCFM and B-LBi07 |
| Single probiotic of L-NCFM alone | Active comparator | Single probiotic pills of L-NCFM alone BID (2x10^10 cfu total bacteria per day) Receives: Dietary Supplement: Single probiotic arm of L-NCFM alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate/compare the effect of the probiotic bacteria L-NCFM alone or in combination with B-LBi07 on expression of intestinal mucosal receptors involved in transmission of nociceptive information.
Measured: 21-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Danisco
- Responsible party
- Principal investigator, Yehuda Ringel, University of North Carolina, Chapel Hill
- Investigators
- Yehuda Ringel, MD, Principal investigator, UNC Dept. Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064661
- Sponsor's protocol ID
- 09-0337
- Status last verified
- Dec 2013
- First submitted
- 5 Feb 2010
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rousseaux C, Thuru X, Gelot A, Barnich N, Neut C, Dubuquoy L, Dubuquoy C, Merour E, Geboes K, Chamaillard M, Ouwehand A, Leyer G, Carcano D, Colombel JF, Ardid D, Desreumaux P. Lactobacillus acidophilus modulates intestinal pain and induces opioid and cannabinoid receptors. Nat Med. 2007 Jan;13(1):35-7. doi: 10.1038/nm1521. Epub 2006 Dec 10.
PubMed 17159985Ringel-Kulka T, Goldsmith JR, Carroll IM, Barros SP, Palsson O, Jobin C, Ringel Y. Lactobacillus acidophilus NCFM affects colonic mucosal opioid receptor expression in patients with functional abdominal pain - a randomised clinical study. Aliment Pharmacol Ther. 2014 Jul;40(2):200-7. doi: 10.1111/apt.12800. Epub 2014 May 22.
PubMed 24853043
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Probiotic Bacteria Lactobacillus Acidophilus NCFM Alone Versus a Combination With Bifidobacterium Lactids - LBi07 in Patients With Mild to Moderate Abdominal Pain/Discomfort and Bloating
- ClinicalTrials.gov ID
- NCT01064661
- Acronym / sponsor ID
- 09-0337
- Keywords
- Probiotics, abdominal pain, abdominal discomfort, bloating, Functional Bowel Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Danisco
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Feb 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.
We are conducting a study to learn if probiotics, which are live bacteria found in food like yogurt and cheese, will improve symptoms of abdominal pain. Individuals participating in this study will take probiotic pills to see if this affects the expression of certain pain receptors in the intestines that relate to pain sensation. Biopsies will be taken from the colon before subjects take the probiotic pills. Subjects will then be given one of two different types of probiotic pills to take for 3-4 weeks. After taking the supplements, more biopsies will be collected to see if any changes have taken places. This study requires one screening visit and two clinic visits to UNC hospital. Subjects will also complete daily diary cards for 2 weeks during the study to record their symptoms and also collect 2 stool samples.
Detailed description
The purpose of this study is to determine if probiotic bacteria, specifically Lactobacillus and Bifidobacterium, have an effect on pain receptors in the colon. Data from animal studies suggest that daily consumption of probiotic bacteria can increase expression of specific receptors in the intestinal mucosa in mice and that these mucosal effects are associated with decrease in intestinal pain sensation. We are interested to see if this is true in humans as well.
Probiotics are live bacteria, which can be found in certain foods like yogurt or cheese prepared with active cultures. The use of probiotics has been shown to be successful in several intestinal disorders, including chronic inflammatory bowel disease (IBD), childhood diarrhea (rotavirus infection), and travelers' diarrhea. This has led to increased interest in their use in patients with symptoms of abdominal pain or discomfort. Although, the data on the use of probiotics in bloating is limited, several reported studies show encouraging results and suggest a symptomatic response and parallel improvement in quality of life.
Probiotics are regarded by the US Food and Drug Administration (FDA) as dietary supplements. They do not require approval by the FDA or any government agency prior to marketing however they are subjected to the FDA jurisdiction regarding their safety, labeling, and health statements. Probiotics can be provided in various forms including food (such as yogurt) or in the format of pills, tablets, caps, and liquids. In this study they will be given in a pill form.
You are being asked to participate in this study because you are currently experiencing abdominal pain or discomfort in your abdomen and you have a functional bowel disorder. In order to determine if these probiotics have an effect, you will be asked to either take a Bifidobacterium probiotic or a blend of Bifidobacterium plus Lactobacillus probiotic. You will be asked to undergo an un-prepped, un-sedated flexible sigmoidoscopy both before your treatment course and after your treatment course. Biopsy samples will be taken during this procedure to analyze certain pain receptor levels, comparing differences between the two treatments of probiotics, and differences in receptors before after treatment. We may use this data for future research in understanding the probiotic function in the gut. We may also perform genetic testing on these specimens in order to look for relationships between genes, the environment, and people's habits or diet, and different diseases. All remaining samples will be stored for-as-yet-unknown tests.
Please note that in order to participate in this study the separate storage consent form is non-optional and must be signed allowing long term storage of stool samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blend probiotic of L-NCFM and B-LBi07 | Active comparator | Dietary Supplement: Blend probiotic arm of L-NCFM and B-LBi07Blend probiotic pills of L-NCFM and B-LBi07 BID (2x10^10 cfu total bacteria per day) |
| Single probiotic of L-NCFM alone | Active comparator | Dietary Supplement: Single probiotic arm of L-NCFM aloneSingle probiotic pills of L-NCFM alone BID (2x10^10 cfu total bacteria per day) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An informed consent has been signed.
- The subject is a female.
- The subject is 18 - 70 years old.
- Active symptoms of abdominal pain or discomfort. Other functional bowel disorders including IBS, functional abdominal pain, and functional bloating are also allowed. For all functional bowel disorders we will use the definition provided by the Rome III criteria.
- The subject's abdominal pain is of mild to moderate in severity. Severity of abdominal pain will also be determined using 10 point likert scale.
Key exclusion criteria (13 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, or symptomatic cholelithiasis.
- The subject has severe abdominal pain symptoms at baseline.
- The subject has a serious, unstable medical condition, such as lung disease, uncontrolled blood pressure, uncontrolled thyroid function, a physical or medical disability or an advanced 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 |
|---|---|---|
| Single probiotic arm of L-NCFM aloneAlso: Lactobacillus Acidophilus NCFMSingle probiotic of L-NCFM alone pills BID (2x10^10 cfu total bacteria per day) | Dietary supplement | Single probiotic of L-NCFM alone |
| Blend probiotic arm of L-NCFM and B-LBi07Also: Lactobacillus Acidophilus NCFM, Bifidobacterium Lactids - LBi07Blend probiotic arm of L-NCFM and B-LBi07 pills BID (2x10^10 cfu total bacteria per day) | Dietary supplement | Blend probiotic of L-NCFM and B-LBi07 |
Primary outcome
Investigate/compare the effect of the probiotic bacteria L-NCFM alone or in combination with B-LBi07 on expression of intestinal mucosal receptors involved in transmission of nociceptive information.
Time frame: 21-28 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 12 Dec 2013.
- Background: PubMed 17159985Rousseaux C, Thuru X, Gelot A, Barnich N, Neut C, Dubuquoy L, Dubuquoy C, Merour E, Geboes K, Chamaillard M, Ouwehand A, Leyer G, Carcano D, Colombel JF, Ardid D, Desreumaux P. Lactobacillus acidophilus modulates intestinal pain and induces opioid and cannabinoid receptors. Nat Med. 2007 Jan;13(1):35-7. doi: 10.1038/nm1521. Epub 2006 Dec 10.
- Derived from this study: PubMed 24853043Ringel-Kulka T, Goldsmith JR, Carroll IM, Barros SP, Palsson O, Jobin C, Ringel Y. Lactobacillus acidophilus NCFM affects colonic mucosal opioid receptor expression in patients with functional abdominal pain - a randomised clinical study. Aliment Pharmacol Ther. 2014 Jul;40(2):200-7. doi: 10.1111/apt.12800. Epub 2014 May 22.
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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
UNC Dept. Gastroenterology and Hepatology
Questions about this trial
What is this clinical trial studying?
A study testing Single probiotic arm of L-NCFM alone and Blend probiotic arm of L-NCFM and B-LBi07 in people with Abdominal Pain and Abdominal Discomfort, run by University of North Carolina, Chapel Hill.
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 13 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 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Investigate/compare the effect of the probiotic bacteria L-NCFM alone or in combination with B-LBi07 on expression of intestinal mucosal receptors involved in transmission of nociceptive information. (time frame: 21-28 days). 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 NCT01064661, which also lists 2 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 12 Dec 2013.