Pilot Study Studying Physiological Effects of Probiotic Pills in Patients With Abdominal Pain/Discomfort and Bloating
Condition: Abdominal Pain; Abdominal Discomfort; Bloating; Functional Bowel Disorders
MeSH terms: Intestinal Diseases; Abdominal Pain
Study type: Interventional

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.
    

Intervention name(s): Single probiotic arm of L-NCFM alone; Blend probiotic arm of L-NCFM and B-LBi07
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Single probiotic of L-NCFM alone pills BID (2x10^10 cfu total bacteria per day); Blend probiotic arm of L-NCFM and B-LBi07 pills BID (2x10^10 cfu total bacteria per day)
Other intervention name(s): Lactobacillus Acidophilus NCFM; Lactobacillus Acidophilus NCFM; Bifidobacterium Lactids - LBi07
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Probiotics; abdominal pain; abdominal discomfort; bloating; Functional Bowel Disorders