Atmo SmartPill Comparison in Gastroparetic and Slow Transit Constipation Patients

NCT04977063 | Completed

• 1 other identifier: ETH01064
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

Brief Summary

This study will compare gastrointestinal transit time measured by the SmartPill and the Atmo gas capsule in patients with gastrointestinal motility disorders. Both of these devices allow gastrointestinal transit time to be measured, however the SmartPill senses pH changes whereas the Atmo Capsule measures gas profiles. A total of 60 participants (30 diagnosed with gastroparesis, 30 with slow transit constipation) will attend Macarthur Clinical School at Western Sydney University after an overnight fast. Participants will consume a standardised meal before ingesting the SmartPill and Atmo Capsule. Each participant will carry a data receiver until passage of the capsules. Anatomical landmarks will be defined by pH changes (SmartPill) or oxygen profiles (Atmo Capsule). Statistical analysis will be performed via linear regression and degrees of agreement for measurements between the two devices. Primary end-points will be the agreement between gastric emptying, small intestinal and colonic transit times generated by the devices.

Conditions

Gastroparesis; Slow Transit

Outcome Measures

Primary Outcomes (2)

• Regional gastrointestinal metrics measured by Atmo gas capsule

  Oxygen equivalence measured by the Atmo gas capsule will allow gastric emptying, small intestinal and colonic transit times to be determined.

  2 years

• Regional gastrointestinal metrics measured by SmartPill

  pH data measured by the SmartPill will allow gastric emptying, small intestinal and colonic transit times to be determined.

  2 years

Study Arms (1)

SmartPill and Atmo capsule

OTHER

The SmartPill and Atmo gas capsule will be tested simultaneously. This will allow the ability of the Atmo gas capsule to measure gastrointestinal transit time to be compared to the SmartPill. The order of swallowing will be randomised using a computer-generated list. The two capsules will be swallowed within 5 minutes of each other

Device: Atmo gas capsule; Device: SmartPill

Interventions

Atmo gas capsule DEVICE

The Atmo Gas Capsule measures the capsules location and motility/transit times through gas sensing capabilities

SmartPill and Atmo capsule

SmartPill DEVICE

The SmartPill measures the capsules location and motility/transit times through pH sensing

SmartPill and Atmo capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with gastroparesis (idiopathic or diabetic) for at least 12 weeks (based on scintigraphy results) and able to eat orally.
• No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes \[hemoglobin A1c \>10% within the past 6 months\], electrolyte imbalance).
• An endoscopy or gastrointestinal barium series within the past 3 years showing no organic disease that is potentially causative of symptoms.
• Ability to stop medications that may alter gastric pH (such as proton pump inhibitors) for 3 days prior to and during study.
• Ability to stop medications that may alter gastrointestinal motility (GLP-1 angonists, anticholinergics, cannabinoids, metformin, antispasmodic, prokinetics) for 3 days prior to and during study.
• Ability to stop antibiotic, probiotic and, prebiotic supplements 7 days before prior to and during study.
• Ability to stop laxatives (docusate, lactulose, sorbitol, senna, bisacodyl), suppositories (glycerin), and enema 3 days prior to and during the study.
• Does not require a MRI scan during the duration of this study

You may not qualify if:

• Previous abdominal and/or pelvic surgery
• History of diverticulitis, diverticular stricture, and other intestinal strictures
• Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)
• Pregnant or nursing
• Patients on long-acting glucagon-like peptide (GLP-1)
• Implantable devices (e.g. pacemaker, defibrillator) \[continuous glucose monitors are permitted\].
• History of bezoar formation
• Dysphagia to solid foods
• Gastric/jejunal feeding tubes

Sponsors & Collaborators

• Atmo Biosciences Pty Ltd: lead
• University of Western Sydney: collaborator

Study Sites (3)

Blacktown Hospital

Blacktown, New South Wales, 2148, Australia

Location

School of Medicine, Western Sydney University

Campbelltown, New South Wales, 2560, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jerry Zhou, PhD BSc

  School of Medicine, Western Sydney University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised control trial involving simultaneous ingestion of two medical devices - the Atmo gas capsule and SmartPill.

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 26, 2021
• Study Start: August 15, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)