| Criteria: |
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Inclusion Criteria:
1. Signed informed consent.
2. 18 - 70 y/o.
3. Existing functional GI symptoms for at least two weeks.
4. No current prescription treatment of functional GI Symptoms. Over the counter (OTC)
medications allowed if still symptomatic despite current OTC therapy.
5. Normal colonoscopy within the last 3 years if age >50.
6. Normal initial screening evaluation including medical history, physical examination,
and laboratory tests (CBC, ESR, blood chemistry including BUN, electrolytes, serum
creatinine, bilirubine, ALT, AST, ALP, amylaze, lipase, TSH, and routine stool
microbiology).
Exclusion Criteria:
1. Physician treatment of functional bowel symptoms in the last 10 months.
2. Current use of prescription medications for functional bowel symptoms.
3. 1 or more bowel movements per day.
4. Contraindication to use of Fleets Enema or the balloon expulsion test.
5. Severe difficulty with defecation and/or recurrent events of unsuccessful defecation
with straining.
6. Severe FBD symptoms at baseline.
7. Medical diagnosis of FBD
8. Daily use of OTC anti-pain, anti-diarrheal or laxative medications.
9. Presence of pre-existing serious, unstable medical condition.
10. Insulin-dependent Diabetes Mellitus.
11. Current diagnosis of major psychiatric disorder or suicide attempt within the last
two years.
12. History of alcohol or substance abuse within two years.
13. Treatment for malignancy other than BCC or SCC within the last 5 years.
14. Self-diagnosis of lactase deficiency that explains symptoms (i.e., symptoms resolved
or reduced significantly with lactose-free diet.)
15. Participation in a drug study within the last 21 days.
16. Antibiotic treatment or probiotic products consumption during the last 4 weeks.
17. Predisposition to infection (i.e. immune system compromised, rheumatic heart disease,
artificial valve, history of bacterial endocarditis, active bacterial disease, etc).
18. History of gastric bezoar (masses trapped in the gastrointestinal tract).
19. Disorders of swallowing and/or severe difficulty swallowing (dysphagia) food or
pills.
20. Suspected strictures, fistulas, colon cancer or other physiological GI obstruction.
21. Allergies to components of the Smart Bar: Granola (Rolled Oats, Evaporated Cane
Juice, Expeller Pressed Canola Oil, Defatted Wheat Germ, Oat Flour, Brown Rice Syrup,
Molasses, Salt, Natural Flavor, Soy Lecithin), Whey Crisp, Rice Syrup, Corn Syrup,
Whey Protein Isolate, Invert Sugar, Puffed Wheat, Apples, Maltodextrin, Sorbitol,
Apple Juice Concentrate, Partially Hydrogenated Vegetable Oil (Cottonseed, Soybean),
Honey, Natural and Artificial Flavor, Salt, Vanilla.
22. Prior GI surgery except for removal of gall bladder or appendix; prior stomach
surgery for acid reflux disease (Nissen fundoplication).
23. Abdominal surgery within the past 3 months.
24. History of inflammatory bowel disease.
25. History of inflammation of the lining of the gastrointestinal tract (diverticulitis
or diverticulosis), tightening of bowels (diverticular stricture), and other
intestinal strictures (per self report).
26. Body Mass Index (BMI) > 40
27. Female of childbearing age not practicing birth control and/or pregnant or lactating.
28. Cardiovascular, endocrine, renal, or other chronic disease likely to affect GI
motility.
29. Use of medical device such as a pacemaker, infusion pump, or insulin pump.
30. Use of following prohibited medications for 1 day prior to the SmartPill ingestion
and the day of SmartPill ingestion: (a) Medication to alter gastric pH (Proton Pump
Inhibitors); (b) antacids;
31. Use of following prohibited medications for 3 days prior to the SmartPill ingestion
and the day of SmartPill ingestion (a) Medication to lower stomach; (b) Medication
that affect GI motility |