Colonic Transit Time Validation Study

The primary aim of this study is to assess the equivalence of SP to ROM through
characterization of device agreement using SP cutoffs for colonic and whole gut transit
(59hrs and 73 hrs respectively) derived from the above mentioned study. The cutoffs are
derived from the 95th percentile of the healthy subjects in the study. Demonstration of
agreement will also serve to validate these SP cutoffs. Device agreement will be evaluated
by comparing the percentage of subjects identified with slow transit versus normal transit
with SmartPill to the percentage of subjects identified with slow versus normal transit with
ROM in the study population. The colonic transit time results will serve as the primary
measure for slow versus normal transit for SmartPill. For ROM test we will employ the
Metcalf protocol which provides a measure of whole gut transit to compare the SmartPill
results to. Additionally, we will characterize gastric emptying and small bowel transit time
of the SmartPill in this population. The SmartPill test will be administered simultaneously
with ROM. A modified Metcalf procedure will be employed for characterization of slow transit
by ROM.

The SmartPill GI Monitoring System offers an alternative non-invasive method for
characterizing disorders of the stomach. The system consists of an ingestible capsule that
houses sensors for pH, temperature, and pressure, a receiver for receiving and storing
signals from the capsule, and software for displaying data on a personal computer. The
capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature
data to a portable receiver worn by the subject. After test completion, the recorded data is
downloaded to a personal computer for subsequent evaluation. This trial is for subjects 18
years of age to 80 years of age.

Inclusion Criteria:

1. Males and females between ages of 18-80 years of age with symptoms of chronic
functional constipation for at least one year.

2. Self reported bowel movement frequency of < 2 bowel movements/week for at least 3 of
the last 6 months.

3. Presenting at least one of the following symptoms as defined by Rome III criteria

- Feeling of incomplete evacuation with > 25% of bowel movements

- Digital maneuvers with > 25% of bowel movements

- Hard stools with > 25% of bowel movements

- Feeling of blockage with > 25% of bowel movements

- Straining with > 25% of bowel movements

4. Constipation, not abdominal pain, as the predominant symptom.

5. Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days
prior to SP and ROM ingestion visit and during the study period.

6. Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for
three days prior to and the day of SmartPill ingestion.

7. No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte
imbalance).

8. A normal colonoscopy or barium enema within 5 years for individuals over 50 years of
age.

Exclusion Criteria:

1. Participation in the previous SmartPill Whole gut transit Study titled "Assessment of
Whole Gut Transit Time Using the SmartPill Capsule: A Multicenter Study" Protocol
Number 122205

2. Previous history of bezoars.

3. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication

4. Any abdominal surgery within the past 3 months

5. Known or history of inflammatory bowel disease

6. History of diverticulitis, diverticular stricture, and other intestinal strictures

7. Tobacco use within eight hours prior to capsule ingestion and during the initial 8
hour recording on Day 0 or the Ingestion visit.

8. Alcohol use within eight hours prior to capsule ingestion and throughout the entire
monitoring period (5 days).

9. BMI > 40 kg/m2

10. Allergies to components of the SmartBar (Appendix IX).

11. Females of childbearing age who are not practicing birth control and/or are pregnant
or lactating. (A urine pregnancy test will be performed on female subjects prior to
capsule ingestion). 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.

12. Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.

13. Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.

14. Any contraindication to use of Fleets Enema.

15. Uncontrolled diabetes with a hemoglobin A1C greater than 10%.

16. Severe dysphagia to food or pills