240 mL Water Drink Study

University of Nottingham

Status

Completed

Conditions

Healthy

Treatments

Other: Spring water

Study type

Interventional

Funder types

Other

Identifiers

NCT01792453

A10012013

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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