Pilot Study Studying Physiological Effects of Probiotic Pills in Patients With Abdominal Pain/Discomfort and Bloating
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|ClinicalTrials.gov Identifier: NCT01064661|
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : December 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Pain Abdominal Discomfort Bloating Functional Bowel Disorders||Dietary Supplement: Single probiotic arm of L-NCFM alone Dietary Supplement: Blend probiotic arm of L-NCFM and B-LBi07||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Active Comparator: Blend probiotic of L-NCFM and B-LBi07
Blend probiotic pills of L-NCFM and B-LBi07 BID (2x10^10 cfu total bacteria per day)
Dietary Supplement: Blend probiotic arm of L-NCFM and B-LBi07
Blend probiotic arm of L-NCFM and B-LBi07 pills BID (2x10^10 cfu total bacteria per day)
Active Comparator: Single probiotic of L-NCFM alone
Single probiotic pills of L-NCFM alone BID (2x10^10 cfu total bacteria per day)
Dietary Supplement: Single probiotic arm of L-NCFM alone
Single probiotic of L-NCFM alone pills BID (2x10^10 cfu total bacteria per day)
Other Name: Lactobacillus Acidophilus NCFM
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064661
|Principal Investigator:||Yehuda Ringel, MD||UNC Dept. Gastroenterology and Hepatology|