What side effects are associated with this type of intervention?

Common treatments for gastroparesis include gastric electrical stimulation, erythromycin, azithromycin, and botulinum toxin injections. Gastric electrical stimulation can cause infection, lead migration, and pain at the implant site. Erythromycin and azithromycin, both antibiotics, can cause gastrointestinal disturbances such as nausea, vomiting, and abdominal pain, and may lead to antibiotic resistance with long-term use. Botulinum toxin injections can result in localized pain, infection, and, in rare cases, muscle weakness. These treatments aim to improve gastric emptying and alleviate symptoms but come with potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for gastroparesis, focusing on improving gastric emptying and managing symptoms. Erythromycin, a macrolide antibiotic, has been used off-label to enhance gastric motility. The gastric electrical neurostimulator (Enterra Therapy system) has been approved under a humanitarian device exemption for diabetic and idiopathic gastroparesis, showing efficacy in reducing symptoms like nausea and vomiting. These treatments aim to address delayed gastric emptying, similar to the objectives of the Atmo Motility Gas Capsule System, which measures gastric emptying time and colonic transit time.

What other types of research exist?

Promising novel alternatives to the Atmo Motility Gas Capsule System for gastroparesis patients include the SmartPill and wireless motility capsules (WMC). These devices measure gastric emptying time and colonic transit time accurately and provide additional data on intraluminal pressure and pH, which can be valuable for comprehensive gastrointestinal motility assessment.

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Motility Monitoring System

Gastrointestinal Transit Monitoring Devices Comparison

N/A

Waitlist Available

Led By Braden Kuo, MD

Research Sponsored by Atmo Biosciences Pty Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (M/F/other) between the ages of 22-80 years of age

Suffering from symptoms of chronic idiopathic constipation based on ROME IV criteria (exclusion of constipation caused by structural abnormalities), participant should have at least 1 bowel motion per week (either assisted or unassisted by medication) AND/OR

Must not have

History of gastric bezoar formation

Patients on long-acting glucagon-like peptide (GLP-1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 10

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects aren't specified for this trial but may include discomfort from swallowing capsules or carrying monitoring equipment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 80 years old.

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I have chronic constipation not caused by physical blockages and have at least one bowel movement weekly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a bezoar in my stomach before.

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I am taking long-acting GLP-1 medication.

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I might have hidden bleeding in my digestive tract.

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I cannot stop taking my medications that affect stomach movement for 3 days before and during the study.

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I have a fistula or blockage in my digestive system.

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I have inflammation in my intestines from radiation.

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I use pain relievers like ibuprofen or naproxen every day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CTT as measured by the Atmo Motility System

CTT as measured by the SmartPill System

GET as measured by the Atmo Motility System

+1 more

Secondary study objectives

Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (USADEs) and device deficiencies

Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by Atmo Motility System

Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by SmartPill

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastroparesis include metoclopramide, domperidone, and erythromycin. Metoclopramide and domperidone are dopamine antagonists that enhance gastric contractions and accelerate gastric emptying, with domperidone having fewer central nervous system side effects. Erythromycin, a macrolide antibiotic, mimics the hormone motilin to stimulate gastric motility. These treatments are essential for gastroparesis patients as they improve gastric emptying and alleviate symptoms, thereby enhancing the patient's quality of life. The Atmo Motility Gas Capsule System, which measures gastric emptying time and colonic transit time, aids in evaluating the effectiveness of these treatments.

Gastrointestinal manometry: a practical tool or a research technique?Gastric pacing improves emptying and symptoms in patients with gastroparesis.