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240 mL Water Drink Study

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ClinicalTrials.gov Identifier: NCT01792453
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : July 4, 2013
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Spring water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: MRI Quantification of Gastric and Small Bowel Liquid Volumes Before and After Ingestion of the Standard Oral Solid Delivery 240 mL Water Drink
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: 240 mL water drink
Volunteers will be asked to drink 240 mL water drink
Other: Spring water



Primary Outcome Measures :
  1. Time course of small bowel liquid volume after ingesting 240 mL of water [ Time Frame: 0 - 120 mins ]
    Time course for the volume of freely mobile water in the small bowel over 2 hours


Secondary Outcome Measures :
  1. Time course of gastric liquid volume after ingesting 240 mL of water [ Time Frame: 0 - 120 mins ]
    Gastric volumes obtained from MRI as a function of time

  2. Number of liquid pockets in the small bowel [ Time Frame: 0 - 120 mins ]
    Assessment of the number of pockets of liquid in the small bowel as seen on the MR images

  3. Volume of liquid pockets in the small bowel [ Time Frame: 0 - 120 mins ]
    The volume of freely mobile liquid in each of the liquid pockets identified on the MR image

  4. Summary information on the location of liquid pockets by quadrant [ Time Frame: 0 - 120 mins ]
    Details on the distribution of the liquid pockets as seen on the MR images



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792453


Locations
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United Kingdom
University of Nottingham
Nottingham, United Kingdom, NG7 2RD
Sponsors and Collaborators
University of Nottingham
University of Michigan
Investigators
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Principal Investigator: Kathryn Murray, PhD University of Nottingham
Principal Investigator: Susan Pritchard, MSc University of Nottingham
Principal Investigator: Caroline Hoad, PhD University of Nottingham
Principal Investigator: Martin Garnett University of Nottingham
Principal Investigator: Penny Gowland, PhD 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

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01792453    
Other Study ID Numbers: A10012013
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: July 2013
Keywords provided by University of Nottingham:
Gastrointestinal physiology
MRI
Small bowel water volumes
Gastric volumes