NCT01792453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 4, 2013

Status Verified

July 1, 2013

Enrollment Period

28 days

First QC Date

February 13, 2013

Last Update Submit

July 3, 2013

Conditions

Healthy

Keywords

Gastrointestinal physiologyMRISmall bowel water volumesGastric volumes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time course of gastric liquid volume after ingesting 240 mL of water

    0 - 120 mins

  • Number of liquid pockets in the small bowel

    0 - 120 mins

  • Volume of liquid pockets in the small bowel

    0 - 120 mins

  • Summary information on the location of liquid pockets by quadrant

    0 - 120 mins

Study Arms (1)

240 mL water drink

EXPERIMENTAL

Volunteers will be asked to drink 240 mL water drink

Other: Spring water

Interventions

Spring waterOTHER
240 mL water drink

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Nottingham, NG7 2RD, United Kingdom

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Luca Marciani, PhD

    University of Nottingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

July 4, 2013

Record last verified: 2013-07

Locations

GB(1)