240 mL Water Drink Study

MRI Quantification of Gastric and Small Bowel Liquid Volumes Before and After Ingestion of the Standard Oral Solid Delivery 240 mL Water Drink

The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. The investigators now want to characterise; in collaboration with the College of Pharmacy at the University of Michigan, the fasting volumes of gastric and small bowel liquid and their time courses over 2 hours after drinking the FDA recommended 240 mL of water drink for oral solid dosage forms testing.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Spring water

Detailed Description

Solid oral delivery is the most frequently used route of administration for pharmaceutical drug products. Along with other important physiological parameters, the volume of liquid in the small intestine (SILV) has the potential to greatly influence the rate and extent of drug dissolution and absorption in the GI tract, or "oral bioperformance". Modeled small bowel absorption of a drug can vary by more than five-fold as SILV decreases from 500 to 50 ml. To obtain reasonable predictions of oral bioperformance scientists must design meaningful in vitro dissolution tests and mechanistic drug transport models that capture the range of SILV in humans. However, little is known about liquid volumes in the gut, mostly due to invasiveness of previous techniques. A recent study has drawn great attention to the possibility of the liquid in the small intestine existing in discrete liquid "pockets" hence it would also be desirable to monitor the time courses and volumes of individual water pockets in the small intestine.

Magnetic resonance imaging (MRI) is the ideal tool to carry out serial and non-invasive imaging of gastrointestinal function. MRI is inherently suited to image liquid materials and this ability has been exploited to image liquids in the undisturbed gastrointestinal tract. Gastric emptying measurements have been long established and validated. Small bowel liquid volumes measurements have been recently validated against naso-duodenal infusion. Ultimately, the findings with this study will provide novel insights on the volume and distribution of ingested liquids in the gastrointestinal tract.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2RD
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Apparently healthy; no medical conditions that might affect the study measurements
• Male or female
• Age between 18 and 55 years of age
• Body mass index (BMI) between 18.5 and 24.9 kg m-2
• Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire

Exclusion Criteria:

• Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
• Known gastrointestinal disease
• Smoking
• History of alcohol or drug abuse
• Taking medication that is likely to affect gastrointestinal function
• Participation in night shift work the week prior to the study day. (Night work is defined as working between midnight and 6 am)
• Strenuous exercise greater than 10 hours per week
• Consumption of more than 21 units of alcohol in a typical week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 240 mL water drink; Volunteers will be asked to drink 240 mL water drink	Other: Spring water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time course of small bowel liquid volume after ingesting 240 mL of water	Time course for the volume of freely mobile water in the small bowel over 2 hours	0 - 120 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time course of gastric liquid volume after ingesting 240 mL of water	Gastric volumes obtained from MRI as a function of time	0 - 120 mins
Number of liquid pockets in the small bowel	Assessment of the number of pockets of liquid in the small bowel as seen on the MR images	0 - 120 mins
Volume of liquid pockets in the small bowel	The volume of freely mobile liquid in each of the liquid pockets identified on the MR image	0 - 120 mins
Summary information on the location of liquid pockets by quadrant	Details on the distribution of the liquid pockets as seen on the MR images	0 - 120 mins

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Kathryn Murray, PhD, University of Nottingham; Principal Investigator: Caroline Hoad, PhD, University of Nottingham; Principal Investigator: Penny Gowland, PhD, University of Nottingham; Principal Investigator: Susan Pritchard, MSc, University of Nottingham; Principal Investigator: Martin Garnett, University of Nottingham; Principal Investigator: Robin Spiller, FRCP, University of Nottingham; Principal Investigator: Gregory Amidon, University of Michigan; Principal Investigator: Gordon Amidon, University of Michigan; Principal Investigator: Deanna Mudie, University of Michigan; Study Director: Luca Marciani, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): July 4, 2013
• Last Update Submitted That Met QC Criteria: July 3, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: MRI; Gastrointestinal physiology; Small bowel water volumes; Gastric volumes
• Other Study ID Numbers: A10012013