Trial Outcomes & Findings for Transit Time and Bacterial Overgrowth Using SmartPill Capsule (NCT NCT00577772)

Last Updated: 2012-10-05

Results Overview

Oro-cecal transit time is the period of time needed by the head of the meal to reach the cecum, which is frequently used as an indicator of small intestinal transit time. Oro-cecal transit was to be determined simultaneously in the study subjects by both the SmartPill technique and the lactulose H\_2BT technique.

Recruitment status

TERMINATED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline

Results posted on

2012-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Participants Healthy Participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.	Symptomatic Participants Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients). The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later. After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days.
Overall Study STARTED	10	7
Overall Study COMPLETED	10	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Participants Healthy Participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.	Symptomatic Participants Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients). The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later. After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Transit Time and Bacterial Overgrowth Using SmartPill Capsule

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Participants n=10 Participants Healthy Participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.	Symptomatic Participants n=7 Participants Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients). The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later. After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to passage of SmartPill, passage of SmartPill estimated no more than 72 hours from baseline

Population: Data were not analyzed as study was terminated early due to low enrollment.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Participants

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Symptomatic Participants

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. John K. DiBaise

Mayo Clinic

Phone: 480-301-6990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Healthy Participants n=10 participants at risk Healthy Participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.	Symptomatic Participants n=7 participants at risk Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients). The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H\_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later. After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days.
Gastrointestinal disorders Abdominal Pain/Cramping	20.0% 2/10 • Number of events 2 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	28.6% 2/7 • Number of events 2 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Gastrointestinal disorders Stomach ache	10.0% 1/10 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	0.00% 0/7 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Musculoskeletal and connective tissue disorders Jaw pain	10.0% 1/10 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	0.00% 0/7 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Nervous system disorders Stress	10.0% 1/10 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	0.00% 0/7 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Musculoskeletal and connective tissue disorders Ankle Sprain	10.0% 1/10 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	0.00% 0/7 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
General disorders Headache	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	28.6% 2/7 • Number of events 2 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Renal and urinary disorders Dysuria	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	14.3% 1/7 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	14.3% 1/7 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Gastrointestinal disorders Diarrhea	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	14.3% 1/7 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Gastrointestinal disorders Nausea	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	28.6% 2/7 • Number of events 2 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	14.3% 1/7 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Gastrointestinal disorders Intermittent vomiting	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	14.3% 1/7 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
General disorders Upper chest pain	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	14.3% 1/7 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Gastrointestinal disorders Intermittent dysphagia	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	14.3% 1/7 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.
Gastrointestinal disorders Lodged SmartPill Capsule in Esophagus	0.00% 0/10 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.	14.3% 1/7 • Number of events 1 • Adverse events were collected for each patient from baseline until the time that the SmartPill was eliminated from the body.