209 Participants Needed

Gastrointestinal Transit Monitoring Devices Comparison

Recruiting at 1 trial location
HP
MB
Overseen ByMichelle Butler
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial aims to compare two different systems for measuring how long it takes for food to move through the stomach and intestines in patients with delayed stomach emptying and slow intestinal transit.

Do I need to stop my current medications for the trial?

Yes, you may need to stop certain medications. Specifically, you must stop medications that alter stomach acid levels (like proton pump inhibitors) 7 days before and during the study, and medications that affect gut movement (like GLP-1 agonists and anticholinergics) 72 hours before and during the study. Laxatives must also be stopped 72 hours before and during the study, with limited use allowed under certain conditions.

What data supports the effectiveness of the Atmo Motility Gas Capsule System and SmartPill Monitoring System treatment?

Research shows that wireless motility capsules, like the ones used in the Atmo Motility Gas Capsule System and SmartPill Monitoring System, can effectively measure how quickly food moves through the stomach and intestines. This helps doctors understand and treat conditions where the digestive system is too slow or too fast.12345

Is the wireless motility capsule safe for humans?

The wireless motility capsule is generally considered safe for humans, with rare cases of capsule retention (when the capsule gets stuck) and malfunction. Some people might have trouble swallowing the capsule, but it avoids the need for more invasive tests.45678

Research Team

BK

Braden Kuo, MD

Principal Investigator

Massachusetts General Hospital

WC

William Chey, MD

Principal Investigator

University of Michigan

Eligibility Criteria

Adults aged 22-80 with IBS-C, chronic idiopathic constipation, or delayed gastric emptying can join. They must have symptoms like nausea, bloating, or infrequent bowel movements and be likely to follow the study rules. Excluded are those with recent surgeries, certain diseases or drug use that affects digestion.

Inclusion Criteria

High probability of compliance and completion of study
You have experienced delayed stomach emptying or have specific symptoms related to digestion and constipation.
You have experienced delayed stomach emptying or have specific symptoms related to stomach discomfort, bloating, or constipation.
See 4 more

Exclusion Criteria

You have had a blockage of stool in your intestines in the past.
May require an MRI scan during the duration of this study
Pregnant or breastfeeding
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo testing with the Atmo Motility Gas Capsule System and SmartPill to measure gastric emptying time and colonic transit time

10 days
1 visit (in-person)

Follow-up

Participants are monitored for adverse events and device deficiencies

21 days

Treatment Details

Interventions

  • Atmo Motility Gas Capsule System
  • SmartPill Monitoring System
Trial OverviewThe trial is testing if the Atmo Gas Capsule is as good as the SmartPill at measuring how fast food moves through the stomach and intestines in people with digestive issues.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Atmo Motility Gas Capsule SystemExperimental Treatment1 Intervention
The Atmo Motility Gas Capsule System (Atmo Biosciences) offers a novel method for measuring GET, SBTT, SLBTT, CTT and WGTT. This device measures temperature, relative humidity, hydrogen concentration and carbon dioxide concentration, along with indicators of fermentation activity, capsule tumble and antenna reflectance as it transit through the GI tract. It has the added benefit of recording information on the fermentation and gas profiles within the GI tract.
Group II: SmartPill Monitoring SystemActive Control1 Intervention
The SmartPill GI Monitoring System (Medtronic) offers a method for measuring gastric emptying time (GET), small bowel transit time (SBTT), colonic transit time (CTT), small bowel large bowel transit time (SLBTT) and whole gut transit time (WGTT) with a single test, which can be used as an aid for the diagnosis of both gastroparesis and slow transit constipation. The SmartPill System measures pH, temperature and pressure. It is approved for use in the measurement of GI transit times by the FDA.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atmo Biosciences Pty Ltd

Lead Sponsor

Trials
4
Recruited
480+

References

Scintigraphy for evaluation of patients for GI motility disorders--the referring physician's perspective. [2016]
The assessment of regional gut transit times in healthy controls and patients with gastroparesis using wireless motility technology. [2021]
Use of wireless motility capsule to determine gastric emptying and small intestinal transit times in critically ill trauma patients. [2012]
Motility of the antroduodenum in healthy and gastroparetics characterized by wireless motility capsule. [2010]
Detection of drug effects on gastric emptying and contractility using a wireless motility capsule. [2021]
Evaluation of regional and whole gut motility using the wireless motility capsule: relevance in clinical practice. [2022]
How to assess regional and whole gut transit time with wireless motility capsule. [2022]
Contractility patterns and gastrointestinal movements monitored by a combined magnetic tracking and motility testing unit. [2022]