Enteral FeedingPhase 1/2NCT01557673
Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
A Phase 1/2 study testing NG bolus feeding over 5 min and Continuous NG feeding over 4 h in people with Enteral Feeding and Nasogastric Feeding, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Following surgery some patients are unable to swallow. For those requiring nutritional support a tube is sometimes passed through the nose into the stomach to provide feeding. Traditionally this type of feeding is given slowly over the course of the day. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Enteral Feeding, Nasogastric Feeding, Diarrhoea
- What is being tested?
- NG bolus feeding over 5 min and Continuous NG feeding over 4 h
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 1/2
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Male
- Able to undergo safe magnetic resonance scanning
Who cannot join
- Female
- Chronic medical conditions
- Regular medication
- Unable to undergo safe magentic resonance scanning
- Previous abdominal surgery
- Smoking
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sir Peter Mansfield Magnetic Resonance Centre
Nottingham, Nottinghamshire, NG7 2RD
About this study
Following surgery some patients are unable to swallow. For those requiring nutritional support a tube is sometimes passed through the nose into the stomach to provide feeding. Traditionally this type of feeding is given slowly over the course of the day. However, it is thought that this mode of feeding might increase the amount of fluid entering the bowel contributing to symptoms of diarrhoea. An alternative strategy of feeding, given in larger volumes in a shorter space of time resembles normal feeding patterns and may reduce the amount of water entering the bowel.
In this study we want to use a non invasive medical imaging technique called "magnetic resonance imaging" (or MRI) to look at the volume of bowel water following these two feeding strategies in 12 healthy volunteers.
Each volunteer will have a tube inserted into the stomach via the nose and undergo the two feeding strategies at least 7 days apart. We will take repeated images using the MRI scanner to assess the bowel response and some samples of blood are required for analysis of blood sugar.
Read the detailed description
- Background. Nutritional support is often required for undernourished patients who are unable to meet daily nutritional requirements. This is often due to lack of consciousness or problems with swallowing, Nasogastric (NG) feeding is often employed to provide active enteric nutritional support. The current approach for delivering this support usually involves pump-assisted continuous feeding spread throughout the course of a day. However, this practice is far from physiological and may promote excessive secretion of fluid into the small bowel, contributing to gastrointestinal symptoms frequently experienced by NG fed patients. Rarely, continuous enteral tube feeding has been associated with small bowel ischaemia or necrosis, although this observation has almost always been made in the critically ill. Bolus feeds given in larger volumes over shorter time periods replicate the pattern of normal feeding. Consequently gastric emptying using this method is slowed and may, therefore, reduce the metabolic demand on the small intestine and prevent excessive accumulation of small bowel fluid.
- Aims. This study aims to investigate the influence of bolus or continuous NG feeding on small bowel fluid content and superior mesenteric blood flow. Our hypothesis is that bolus NG feeding results in lower small bowel fluid secretion and a reduction in superior mesenteric artery blood flow in comparison to individuals who are bolus NG fed.
- Experimental protocol and methods. This is a single-centre, cross-over study involving 12 healthy volunteers. Two studies will be undertaken for each volunteer approximately 7 days apart:
- Tube bolus (TB): feed administered via the NG tube over 5 min.
- Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h. The sequence of treatment allocations will be concealed to assessors until all interventions, data collection, and statistical analysis has been completed. Subjects will be asked to arrive at 8:30 a.m. at the Sir Peter Mansfield Magnetic Resonance 1.5T, University of Nottingham, having abstained from alcohol, caffeine-containing drinks, and any medication for at least 24 h prior to the study, as well as having fasted overnight. An 80 cm 8FR Freka (Fresenius Kabi, Runcorn, UK) fine bore nasogastric (NG) tube will be inserted into the stomach via the nose as well as a cannula in the ante cubital fossa for blood sampling. The position of the NG tube will be verified by magnetic resonance imaging (MRI). Once the tube is sited, the volunteer will be asked to sit for 5 min in order to allow the tubes to settle and the body adapt to their presence. Following NG intubation subjects will undergo baseline MRI scanning and blood sampling for glucose, insulin and PYY. Feeding will commence at time 0. Scanning and blood tests will proceed at 30 min intervals for a total of 4 h. The feed used in all studies will be 400 ml of Resource® Energy Vanilla nutrient drink (Nestle Nutrition, Société des Produits Nestlé S.A), which is typical of a standard oral supplement. In the TB study arm the supplement will be administered through the NG tube via syringes over 5 min; and in the TD study the feed will be administered using a pump at a rate of 100 ml/h for 4 h.
- Measurable end points/statistical power of the study. Primary endpoint: Small bowel water content (SBWC). Secondary endpoints: Superior mesenteric artery blood flow, gastric content emptying time, plasma concentrations of glucose, insulin and peptide YY (PYY). Previous work using mannitol and glucose indicates that mean (SD) SBWC at 40 minutes postprandially after ingesting 300ml glucose was 47 (SD 15) and using n=10 we calculate we can detect a difference of 17 ml (36%) between interventions with 90% power. We plan to recruit 12 to allow for dropouts.
- Conditions
- Enteral Feeding, Nasogastric Feeding, Diarrhoea
- Being tested
- NG bolus feeding over 5 min, Continuous NG feeding over 4 h
- Keywords
- Nasogastric, Small bowel water, Diarrhoea, Mesenteric blood flow, Enteral feeding
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG bolus feeding over 5 minDietary supplement
Also called Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Tube bolus (TB): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., administered via the NG tube over 5 min.
Continuous NG feeding over 4 hDietary supplement
Also called Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A
Continuous tube drip feeding (TD): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., delivered via feeding pump through the NG tube over 4 h.
| Study group | Role | What they receive |
|---|---|---|
| NG bolus feeding over 5 min | Active comparator | Tube bolus (TB): feed administered via syringe through NG tube over 5 min. Receives: Dietary Supplement: NG bolus feeding over 5 min |
| Continuous NG feeding over 4 h | Placebo comparator | Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h. Receives: Dietary Supplement: Continuous NG feeding over 4 h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel water volume (ml)
Small bowel water content assessed by magnetic resonance imaging.
Measured: 0-240 min
Secondary outcomes (5)
Gastric emptying
Gastric volume assessed by magnetic resonance imaging.
Measured: 0-240 min
Superior mesenteric artery blood flow
Superior mesenteric artery blood flow and velocity assessed by magnetic resonance imaging.
Measured: 0-240 min
Peptide YY
Serum concentration of peptide YY
Measured: 0-240 min
Insulin
Serum concentration of insulin
Measured: 0-240 min
Glucose
Serum concentration of glucose
Measured: 0-240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Enteral FeedingStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abeed H Chowdhury, BSc MRCS, Principal investigator, University of NottinghamTim Bowling, MD FRCP, Study chair, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557673
- Sponsor's protocol ID
- H062011
- Status last verified
- May 2013
- First submitted
- 12 Mar 2012
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dempsey DT, Mullen JL, Buzby GP. The link between nutritional status and clinical outcome: can nutritional intervention modify it? Am J Clin Nutr. 1988 Feb;47(2 Suppl):352-6. doi: 10.1093/ajcn/47.2.352.
PubMed 3124596Stroud M, Duncan H, Nightingale J; British Society of Gastroenterology. Guidelines for enteral feeding in adult hospital patients. Gut. 2003 Dec;52 Suppl 7(Suppl 7):vii1-vii12. doi: 10.1136/gut.52.suppl_7.vii1. No abstract available.
PubMed 14612488Keohane PP, Attrill H, Love M, Frost P, Silk DB. Relation between osmolality of diet and gastrointestinal side effects in enteral nutrition. Br Med J (Clin Res Ed). 1984 Mar 3;288(6418):678-80. doi: 10.1136/bmj.288.6418.678.
PubMed 6421429Kocan MJ, Hickisch SM. A comparison of continuous and intermittent enteral nutrition in NICU patients. J Neurosci Nurs. 1986 Dec;18(6):333-7. doi: 10.1097/01376517-198612000-00004.
PubMed 2949027Sarap AN, Sarap MD, Childers J. Small bowel necrosis in association with jejunal tube feeding. JAAPA. 2010 Nov;23(11):28, 30-2. doi: 10.1097/01720610-201011000-00006.
PubMed 21086887Melis M, Fichera A, Ferguson MK. Bowel necrosis associated with early jejunal tube feeding: A complication of postoperative enteral nutrition. Arch Surg. 2006 Jul;141(7):701-4. doi: 10.1001/archsurg.141.7.701.
PubMed 16847244Lobo DN, Hendry PO, Rodrigues G, Marciani L, Totman JJ, Wright JW, Preston T, Gowland P, Spiller RC, Fearon KC. Gastric emptying of three liquid oral preoperative metabolic preconditioning regimens measured by magnetic resonance imaging in healthy adult volunteers: a randomised double-blind, crossover study. Clin Nutr. 2009 Dec;28(6):636-41. doi: 10.1016/j.clnu.2009.05.002. Epub 2009 Jun 4.
PubMed 19500889Hoad CL, Marciani L, Foley S, Totman JJ, Wright J, Bush D, Cox EF, Campbell E, Spiller RC, Gowland PA. Non-invasive quantification of small bowel water content by MRI: a validation study. Phys Med Biol. 2007 Dec 7;52(23):6909-22. doi: 10.1088/0031-9155/52/23/009. Epub 2007 Nov 8.
PubMed 18029983Marciani L, Cox EF, Hoad CL, Pritchard S, Totman JJ, Foley S, Mistry A, Evans S, Gowland PA, Spiller RC. Postprandial changes in small bowel water content in healthy subjects and patients with irritable bowel syndrome. Gastroenterology. 2010 Feb;138(2):469-77, 477.e1. doi: 10.1053/j.gastro.2009.10.055. Epub 2009 Nov 10.
PubMed 19909743
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bolus and Continuous Nasogastric Feeding on Small Bowel Water Content and Blood Flow
- ClinicalTrials.gov ID
- NCT01557673
- Acronym / sponsor ID
- H062011
- Conditions
- Enteral Feeding, Nasogastric Feeding, Diarrhoea
- Keywords
- Nasogastric, Small bowel water, Diarrhoea, Mesenteric blood flow, Enteral feeding
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Mar 2012 (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.
Following surgery some patients are unable to swallow. For those requiring nutritional support a tube is sometimes passed through the nose into the stomach to provide feeding. Traditionally this type of feeding is given slowly over the course of the day. However, it is thought that this mode of feeding might increase the amount of fluid entering the bowel contributing to symptoms of diarrhoea. An alternative strategy of feeding, given in larger volumes in a shorter space of time resembles normal feeding patterns and may reduce the amount of water entering the bowel.
In this study we want to use a non invasive medical imaging technique called "magnetic resonance imaging" (or MRI) to look at the volume of bowel water following these two feeding strategies in 12 healthy volunteers.
Each volunteer will have a tube inserted into the stomach via the nose and undergo the two feeding strategies at least 7 days apart. We will take repeated images using the MRI scanner to assess the bowel response and some samples of blood are required for analysis of blood sugar.
Detailed description
- Background. Nutritional support is often required for undernourished patients who are unable to meet daily nutritional requirements. This is often due to lack of consciousness or problems with swallowing, Nasogastric (NG) feeding is often employed to provide active enteric nutritional support. The current approach for delivering this support usually involves pump-assisted continuous feeding spread throughout the course of a day. However, this practice is far from physiological and may promote excessive secretion of fluid into the small bowel, contributing to gastrointestinal symptoms frequently experienced by NG fed patients. Rarely, continuous enteral tube feeding has been associated with small bowel ischaemia or necrosis, although this observation has almost always been made in the critically ill. Bolus feeds given in larger volumes over shorter time periods replicate the pattern of normal feeding. Consequently gastric emptying using this method is slowed and may, therefore, reduce the metabolic demand on the small intestine and prevent excessive accumulation of small bowel fluid.
- Aims. This study aims to investigate the influence of bolus or continuous NG feeding on small bowel fluid content and superior mesenteric blood flow. Our hypothesis is that bolus NG feeding results in lower small bowel fluid secretion and a reduction in superior mesenteric artery blood flow in comparison to individuals who are bolus NG fed.
- Experimental protocol and methods. This is a single-centre, cross-over study involving 12 healthy volunteers. Two studies will be undertaken for each volunteer approximately 7 days apart:
- Tube bolus (TB): feed administered via the NG tube over 5 min.
- Continuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h. The sequence of treatment allocations will be concealed to assessors until all interventions, data collection, and statistical analysis has been completed. Subjects will be asked to arrive at 8:30 a.m. at the Sir Peter Mansfield Magnetic Resonance 1.5T, University of Nottingham, having abstained from alcohol, caffeine-containing drinks, and any medication for at least 24 h prior to the study, as well as having fasted overnight. An 80 cm 8FR Freka (Fresenius Kabi, Runcorn, UK) fine bore nasogastric (NG) tube will be inserted into the stomach via the nose as well as a cannula in the ante cubital fossa for blood sampling. The position of the NG tube will be verified by magnetic resonance imaging (MRI). Once the tube is sited, the volunteer will be asked to sit for 5 min in order to allow the tubes to settle and the body adapt to their presence. Following NG intubation subjects will undergo baseline MRI scanning and blood sampling for glucose, insulin and PYY. Feeding will commence at time 0. Scanning and blood tests will proceed at 30 min intervals for a total of 4 h. The feed used in all studies will be 400 ml of Resource® Energy Vanilla nutrient drink (Nestle Nutrition, Société des Produits Nestlé S.A), which is typical of a standard oral supplement. In the TB study arm the supplement will be administered through the NG tube via syringes over 5 min; and in the TD study the feed will be administered using a pump at a rate of 100 ml/h for 4 h.
- Measurable end points/statistical power of the study. Primary endpoint: Small bowel water content (SBWC). Secondary endpoints: Superior mesenteric artery blood flow, gastric content emptying time, plasma concentrations of glucose, insulin and peptide YY (PYY). Previous work using mannitol and glucose indicates that mean (SD) SBWC at 40 minutes postprandially after ingesting 300ml glucose was 47 (SD 15) and using n=10 we calculate we can detect a difference of 17 ml (36%) between interventions with 90% power. We plan to recruit 12 to allow for dropouts.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NG bolus feeding over 5 min | Active comparator | Dietary Supplement: NG bolus feeding over 5 minTube bolus (TB): feed administered via syringe through NG tube over 5 min. |
| Continuous NG feeding over 4 h | Placebo comparator | Dietary Supplement: Continuous NG feeding over 4 hContinuous tube drip feeding (TD): feed pump delivered via the NG tube over 4 h. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- Male
- Able to undergo safe magnetic resonance scanning
Key exclusion criteria (6 listed)
- Female
- Chronic medical conditions
- Regular medication
- Unable to undergo safe magentic resonance scanning
- Previous abdominal surgery
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 |
|---|---|---|
| NG bolus feeding over 5 minAlso: Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.ATube bolus (TB): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., administered via the NG tube over 5 min. | Dietary supplement | NG bolus feeding over 5 min |
| Continuous NG feeding over 4 hAlso: Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.AContinuous tube drip feeding (TD): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., delivered via feeding pump through the NG tube over 4 h. | Dietary supplement | Continuous NG feeding over 4 h |
Primary outcome
Small bowel water volume (ml)
Time frame: 0-240 min
Small bowel water content assessed by magnetic resonance imaging.
5 secondary outcomes
Gastric emptying
Time frame: 0-240 min
Superior mesenteric artery blood flow
Time frame: 0-240 min
Peptide YY
Time frame: 0-240 min
Insulin
Time frame: 0-240 min
Glucose
Time frame: 0-240 min
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 6 May 2013.
- Background: PubMed 3124596Dempsey DT, Mullen JL, Buzby GP. The link between nutritional status and clinical outcome: can nutritional intervention modify it? Am J Clin Nutr. 1988 Feb;47(2 Suppl):352-6. doi: 10.1093/ajcn/47.2.352.
- Background: PubMed 14612488Stroud M, Duncan H, Nightingale J; British Society of Gastroenterology. Guidelines for enteral feeding in adult hospital patients. Gut. 2003 Dec;52 Suppl 7(Suppl 7):vii1-vii12. doi: 10.1136/gut.52.suppl_7.vii1. No abstract available.
- Background: PubMed 6421429Keohane PP, Attrill H, Love M, Frost P, Silk DB. Relation between osmolality of diet and gastrointestinal side effects in enteral nutrition. Br Med J (Clin Res Ed). 1984 Mar 3;288(6418):678-80. doi: 10.1136/bmj.288.6418.678.
- Background: PubMed 2949027Kocan MJ, Hickisch SM. A comparison of continuous and intermittent enteral nutrition in NICU patients. J Neurosci Nurs. 1986 Dec;18(6):333-7. doi: 10.1097/01376517-198612000-00004.
- Background: PubMed 21086887Sarap AN, Sarap MD, Childers J. Small bowel necrosis in association with jejunal tube feeding. JAAPA. 2010 Nov;23(11):28, 30-2. doi: 10.1097/01720610-201011000-00006.
- Background: PubMed 16847244Melis M, Fichera A, Ferguson MK. Bowel necrosis associated with early jejunal tube feeding: A complication of postoperative enteral nutrition. Arch Surg. 2006 Jul;141(7):701-4. doi: 10.1001/archsurg.141.7.701.
- Background: PubMed 19500889Lobo DN, Hendry PO, Rodrigues G, Marciani L, Totman JJ, Wright JW, Preston T, Gowland P, Spiller RC, Fearon KC. Gastric emptying of three liquid oral preoperative metabolic preconditioning regimens measured by magnetic resonance imaging in healthy adult volunteers: a randomised double-blind, crossover study. Clin Nutr. 2009 Dec;28(6):636-41. doi: 10.1016/j.clnu.2009.05.002. Epub 2009 Jun 4.
- Background: PubMed 18029983Hoad CL, Marciani L, Foley S, Totman JJ, Wright J, Bush D, Cox EF, Campbell E, Spiller RC, Gowland PA. Non-invasive quantification of small bowel water content by MRI: a validation study. Phys Med Biol. 2007 Dec 7;52(23):6909-22. doi: 10.1088/0031-9155/52/23/009. Epub 2007 Nov 8.
- Background: PubMed 19909743Marciani L, Cox EF, Hoad CL, Pritchard S, Totman JJ, Foley S, Mistry A, Evans S, Gowland PA, Spiller RC. Postprandial changes in small bowel water content in healthy subjects and patients with irritable bowel syndrome. Gastroenterology. 2010 Feb;138(2):469-77, 477.e1. doi: 10.1053/j.gastro.2009.10.055. Epub 2009 Nov 10.
Related trials for Enteral Feeding
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
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.
Abeed H Chowdhury, BSc MRCS principal investigator
University of Nottingham
Tim Bowling, MD FRCP study chair
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NG bolus feeding over 5 min and Continuous NG feeding over 4 h in people with Enteral Feeding and Nasogastric Feeding, 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 3 inclusion and 6 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 6 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Small bowel water volume (ml) (time frame: 0-240 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01557673, which also lists 9 linked publications.
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 6 May 2013.