Pilot Study Studying Physiological Effects of Probiotic Pills in Patients With Abdominal Pain/Discomfort and Bloating

This is an interventional basic science trial for Abdominal Pain focused on measuring Probiotics, abdominal pain, abdominal discomfort, bloating, Functional Bowel Disorders Read More

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.