240 mL Water Drink Study

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792453
• Other study ID #: A10012013
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: July 3, 2013
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: no oversight authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Spring water

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	University of Michigan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No