Trial Outcomes & Findings for Pilot Study Using a Wireless Motility Capsule (NCT NCT01102894)

Results Overview

The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

5 days

Results posted on

2014-11-04

Participant Flow

Subjects were recruited from the University of Minnesota via fliers on the St. Paul campus

Exclusion criteria included contraindicated conditions for the SmartPill: dysphasia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, previous gastrointestinal surgery, implanted electro-mechanical medical devices, and medications shown to influence gastrointestinal transit time.

Participant milestones

Participant milestones
Measure	High Fiber and Low Fiber Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study Using a Wireless Motility Capsule

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Fiber and High Fiber n=10 Participants Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber SmartPill : SmartPill
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: All participants had their transit time assessed.

The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.

Outcome measures

Outcome measures
Measure	High Fiber n=10 Participants Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill	Low Fiber n=10 Participants Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
Whole Gut Transit Time	22.5 hours Standard Deviation 14.6	31.4 hours Standard Deviation 5.8

SECONDARY outcome

Timeframe: Day 4

Population: Each participant completed a gastrointestinal tolerance questionnaire during each treatment period.

Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value.

Outcome measures

Outcome measures
Measure	High Fiber n=10 Participants Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill	Low Fiber n=10 Participants Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
Gastrointestinal Tolerance	9.5 units on a scale Standard Deviation 1.7	6.8 units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Day 1

Population: Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake

Total dietary fiber consumed.

Outcome measures

Outcome measures
Measure	High Fiber n=10 Participants Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill	Low Fiber n=10 Participants Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time SmartPill : SmartPill
Food Intake Diary	14 g Standard Deviation 7.5	15 g Standard Deviation 7

Adverse Events

High Fiber

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Fiber

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joanne Slavin

University of Minnesota

Phone: 612-624-7234

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place