Clinical trial NCT01792453: 240 mL Water Drink Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Gastrointestinal physiology
MRI
Small bowel water volumes
Gastric volumes
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2013-02-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Time course of small bowel liquid volume after ingesting 240 mL of water
timeFrame: 0 - 120 mins
Secondary outcomes:
measure: Time course of gastric liquid volume after ingesting 240 mL of water
timeFrame: 0 - 120 mins
measure: Number of liquid pockets in the small bowel
timeFrame: 0 - 120 mins
measure: Volume of liquid pockets in the small bowel
timeFrame: 0 - 120 mins
measure: Summary information on the location of liquid pockets by quadrant
timeFrame: 0 - 120 mins
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Kathryn Murray, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Susan Pritchard, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Caroline Hoad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Martin Garnett
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Penny Gowland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Robin Spiller, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Gregory Amidon
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Gordon Amidon
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Deanna Mudie
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Luca Marciani, PhD
role: STUDY_DIRECTOR
References: