Atmo SmartPill Comparison in Gastroparetic and Slow Transit Constipation Patients
Condition: Gastroparesis; Slow Transit
MeSH terms: Gastroparesis; Constipation
Study type: Interventional

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.
    

Detailed description: 
      The Atmo gas capsule is an ingestible, wireless, gas sensing capsule that is currently being
      developed and commercialised as a biomarker tool for gastrointestinal disorders. Following
      ingestion, the Atmo gas capsule transmits information about gases and temperature to an
      external receiver. The oxygen concentration profiles generated allow the passage of the
      capsule between aerobic (small intestine) and anaerobic (large intestine) to be
      characterised. The practical application of the Atmo Capsule is currently limited by the need
      to validate oxygen concentrations as a marker of position within the gastrointestinal tract.
      Preliminary studies using intestinal ultrasound have shown that migration of the Atmo capsule
      from the stomach to the duodenum, and its passage from terminal ileum to caecum, corresponds
      with major changes in oxygen concentration.

      The SmartPill measures pH and offers gold-standard measurements of gastrointestinal transit
      times. To validate the ability of the Atmo Capsule to measure gastrointestinal transit time,
      this device will be compared to the SmartPill. This will allow the equivalence of these two
      devices in gastrointestinal transit measurements to be evaluated.

      This study aims to compare gastrointestinal transit times using immediately sequential
      ingestion of the SmartPill and Atmo capsule in patients with gastrointestinal motility
      disorders. A total of 60 participants diagnosed with either gastroparesis (n=30) or slow
      transit constipation (n=30) will be recruited by advertisement (via online support group
      pages, such as Gastroparesis Australia) and word-of-mouth. Potential participants will be
      screened for eligibility. Suitable individuals will be sent a Participant Information Sheet
      and Consent Form for review. Participants will be asked to stop proton pump inhibitors,
      histamine receptor blockers and antacids 3 days prior to the study and during the study.
      Medications that affect gastric motility will also be stopped 48 hours before the start of
      the study and during the study. Following an overnight fast, participants will attend the
      Macarthur Clinical School, Western Sydney University, where the Principal Investigator (Dr
      Jerry Zhou) will review the Patient Information Sheet with each participant and obtain
      informed written consent. Participants will then be asked to consume a cereal bar with 200mL
      of water. Participants will subsequently ingest the SmartPill and Atmo capsule. The order of
      swallowing these devices will be randomised with a computer-generated list. Participants will
      be monitored for 15 minutes post-ingestion. Subjects will then fast for the next 6 hours,
      after which they will consume their normal meals for the rest of the day. The data receiver
      for both the SmartPill and Atmo capsule will be worn or kept within 1.5 metres of the body
      until passage of the capsule has been confirmed by observation in the toilet bowl or signal
      loss from both capsules after a bowel movement.

      Adverse events, bowel movements and the presence of gastrointestinal symptoms will be
      recorded in a digital diary (as part of the Atmo receiver system) whilst the Atmo capsule is
      in the body. Once both devices have passed from the body, participants will attend Macarthur
      Clinical School, where receivers will be returned and an investigator will review the digital
      diary with them.The investigator will follow up with the participant via phone or email
      approximately one week after the study to enquire about symptoms and adverse effects.

      For the SmartPill, anatomical landmarks will be identified by changes in pH profiles along
      the gastrointestinal tract as previously reported in the literature. More specifically,
      gastric emptying time will be defined by the time of capsule ingestion to the presence of a
      sharp rise in pH (more than three units), where the capsule passes from an acidic environment
      (pH ≤4) in the stomach to a more basic environment (pH >6) in the duodenum. Small intestinal
      transit will be determined by the time between the end of gastric emptying and identification
      of the ileo-caecal junction (a fall in ≥1 pH unit distal to gastric emptying). Colonic
      transit time will be defined as the time from ileocaecal junction to exit from the body.
      Whole gut transit time will be calculated as time of oral ingestion to exit from the body.

      For the Atmo capsule, oxygen profiles will be used to characterise gastric emptying, small
      intestinal and colonic transit. Whole gut transit time will be calculated based on a change
      in temperature from exiting the body. The primary end-points of this study will be the
      agreement between gastric emptying, small intestinal and colonic transit times generated by
      the gas-sensing capsule vs wireless pH-motility. Statistical analysis with linear regression
      and by degrees of agreement (Bland-Altman tests) of measurements between the two devices will
      address these end-points. More subjects will be studied pending the results of this pilot
      study. The results, conduct and reporting of this study will conform to the STARD 2015
      guidelines.
    

Intervention name(s): Atmo gas capsule; SmartPill
Intervention type(s): Device; Device
Intervention description(s): The Atmo Gas Capsule measures the capsules location and motility/transit times through gas sensing capabilities; The SmartPill measures the capsules location and motility/transit times through pH sensing
Intervention model: Single Group Assignment
Intervention model description: Randomised control trial involving simultaneous ingestion of two medical devices - the Atmo gas capsule and SmartPill.
Masking: None (Open Label)
Primary purpose: Diagnostic