Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT01064661
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2010-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Studying Physiological Effects of Probiotic Pills in Patients With Abdominal Pain/Discomfort and Bloating
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: