Abdominal Pain Clinical Trial
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. An informed consent has been signed. 2. The subject is a female. 3. The subject is 18 - 70 years old. 4. 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. 5. 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. 6. 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. Exclusion Criteria: 1. 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. 2. The subject has severe abdominal pain symptoms at baseline. 3. 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. 4. The subject has insulin-dependent Diabetes Mellitus. 5. The subject had a major psychiatric diagnosis or a suicide attempt within the last two years. 6. The subject has a history of alcohol or substance abuse within two years. 7. The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer). 8. 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.) 9. The subject had previous significant gastric or intestinal surgery (except appendectomy and gall bladder surgery). 10. 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.) 11. 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) 12. 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. 13. 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Danisco |
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. Epub 2006 Dec 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 21-28 days | No |
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