HealthyNCT01792453
240 mL Water Drink Study
A study testing Spring water in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Spring water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottingham, NG7 2RD
About this 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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Spring water
- Keywords
- Gastrointestinal physiology, MRI, Small bowel water volumes, Gastric volumes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spring waterOther
| Study group | Role | What they receive |
|---|---|---|
| 240 mL water drink | Experimental | Volunteers will be asked to drink 240 mL water drink Receives: Other: Spring water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 - 120 mins
Secondary outcomes (4)
Time course of gastric liquid volume after ingesting 240 mL of water
Gastric volumes obtained from MRI as a function of time
Measured: 0 - 120 mins
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
Measured: 0 - 120 mins
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
Measured: 0 - 120 mins
Summary information on the location of liquid pockets by quadrant
Details on the distribution of the liquid pockets as seen on the MR images
Measured: 0 - 120 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Kathryn Murray, PhD, Principal investigator, University of NottinghamSusan Pritchard, MSc, Principal investigator, University of NottinghamCaroline Hoad, PhD, Principal investigator, University of NottinghamMartin Garnett, Principal investigator, University of NottinghamPenny Gowland, PhD, Principal investigator, University of NottinghamRobin Spiller, FRCP, Principal investigator, University of NottinghamGregory Amidon, Principal investigator, University of MichiganGordon Amidon, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792453
- Sponsor's protocol ID
- A10012013
- Status last verified
- Jul 2013
- First submitted
- 13 Feb 2013
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01792453
- Acronym / sponsor ID
- A10012013
- Conditions
- Healthy
- Keywords
- Gastrointestinal physiology, MRI, Small bowel water volumes, Gastric volumes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 240 mL water drink | Experimental | Other: Spring waterVolunteers will be asked to drink 240 mL water drink |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spring water | Other | 240 mL water drink |
Primary outcome
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
4 secondary outcomes
Time course of gastric liquid volume after ingesting 240 mL of water
Time frame: 0 - 120 mins
Number of liquid pockets in the small bowel
Time frame: 0 - 120 mins
Volume of liquid pockets in the small bowel
Time frame: 0 - 120 mins
Summary information on the location of liquid pockets by quadrant
Time frame: 0 - 120 mins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Murray, PhD principal investigator
University of Nottingham
Susan Pritchard, MSc principal investigator
University of Nottingham
Caroline Hoad, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spring water in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time course of small bowel liquid volume after ingesting 240 mL of water (time frame: 0 - 120 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2013.