Delayed Gastric EmptyingNCT02745028
Monosodium Glutamate on Gastric Emptying
A study testing Monosodium glutamate in people with Delayed Gastric Emptying, run by Veronica Beatriz Busoni.
Trial summary
Children with a radionuclide gastric emptying test with abnormal results will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose of the study is to determine if a single dose of monosodium glutamate can shorten the gastric emptying time. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Delayed Gastric Emptying
- What is being tested?
- Monosodium glutamate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Oct 2017
- 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 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with delayed gastric emptying not receiving prokinetic medication in the last 72 hours
Who cannot join
- Prior gastrointestinal surgery, patients with known history of reaction to monosodium glutamate. History of neoplasia, autoimmune or inflammatory bowel disease.
About this study
Official title: Effect of a Single Dose of Monosodium Glutamate on Delayed Gastric Emptying in Children
Children with a radionuclide gastric emptying test with abnormal results will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose of the study is to determine if a single dose of monosodium glutamate can shorten the gastric emptying time.
Read the detailed description
There is evidence that monosodium glutamate has effects on synapsis at the gastric and duodenum level that results in stimulation of contractility resulting on increase rate of gastric emptying. The purpose of the study is to demonstrate that the administration of a single dose of monosodium glutamate can shorten the gastric emptying time.
Patients with a prior study indicating a delay of gastric empting time, will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. Each patient will serve as her/his own control. Results will be analysed by pair-T test.
- Conditions
- Delayed Gastric Emptying
- Being tested
- Monosodium glutamate
- Keywords
- delayed gastric emptying, children, monosodium glutamate
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monosodium glutamateDietary supplement
A single dose of weight adjusted monosodium glutamate will be added at the time of a repeat radionuclide gastric emptying study
| Study group | Role | What they receive |
|---|---|---|
| With monosodium glutamate | Other | Results of one time gastric emptying study with a single dose of monosodium glutamate; 1 g for weight greater than 45 kg, 700mg between 35 and 44,900 kg, 600mg between 25 and 34,900, 500mg between 15 and 25 kg and 250mg in less than 15 kg Receives: Dietary Supplement: Monosodium glutamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced gastric emptying time
Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline
Measured: During the test (4 hours from intake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startApr 2016 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: The protocol was cancelled becouse lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Delayed Gastric EmptyingStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veronica Beatriz Busoni
- Sponsor type
- University, hospital or other
- Collaborators
- International Glutamate Technical Committee
- Responsible party
- Sponsor-investigator, Veronica Beatriz Busoni, Hospital Italiano de Buenos Aires
- Investigators
- Veronica B Busoni, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745028
- Sponsor's protocol ID
- 2404
- Status last verified
- Feb 2023
- First submitted
- 7 Apr 2016
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Teramoto H, Shimizu T, Yogo H, Nishimiya Y, Hori S, Kosugi T, Nakayama S. Gastric emptying and duodenal motility upon intake of a liquid meal with monosodium glutamate in healthy subjects. Physiol Rep. 2014 Jan 6;2(1):e00187. doi: 10.1002/phy2.187. eCollection 2014 Jan 1.
PubMed 24744869Zai H, Kusano M, Hosaka H, Shimoyama Y, Nagoshi A, Maeda M, Kawamura O, Mori M. Monosodium L-glutamate added to a high-energy, high-protein liquid diet promotes gastric emptying. Am J Clin Nutr. 2009 Jan;89(1):431-5. doi: 10.3945/ajcn.2008.26180. Epub 2008 Dec 3.
PubMed 19056566Boutry C, Matsumoto H, Airinei G, Benamouzig R, Tome D, Blachier F, Bos C. Monosodium glutamate raises antral distension and plasma amino acid after a standard meal in humans. Am J Physiol Gastrointest Liver Physiol. 2011 Jan;300(1):G137-45. doi: 10.1152/ajpgi.00299.2010. Epub 2010 Oct 28.
PubMed 21030612Hosaka H, Kusano M, Zai H, Kawada A, Kuribayashi S, Shimoyama Y, Nagoshi A, Maeda M, Kawamura O, Mori M. Monosodium glutamate stimulates secretion of glucagon-like peptide-1 and reduces postprandial glucose after a lipid-containing meal. Aliment Pharmacol Ther. 2012 Nov;36(9):895-903. doi: 10.1111/apt.12050.
PubMed 22978669
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Dose of Monosodium Glutamate on Delayed Gastric Emptying in Children
- ClinicalTrials.gov ID
- NCT02745028
- Acronym / sponsor ID
- 2404
- Conditions
- Delayed Gastric Emptying
- Keywords
- delayed gastric emptying, children, monosodium glutamate
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The protocol was cancelled becouse lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Veronica Beatriz BusoniUniversity, hospital or other
- Collaborators
- International Glutamate Technical Committee
- Study start
- Apr 2016 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 20 Apr 2016 (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.
Children with a radionuclide gastric emptying test with abnormal results will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. The purpose of the study is to determine if a single dose of monosodium glutamate can shorten the gastric emptying time.
Detailed description
There is evidence that monosodium glutamate has effects on synapsis at the gastric and duodenum level that results in stimulation of contractility resulting on increase rate of gastric emptying. The purpose of the study is to demonstrate that the administration of a single dose of monosodium glutamate can shorten the gastric emptying time.
Patients with a prior study indicating a delay of gastric empting time, will undergo a second test with the addition of a weight adjusted dose of monosodium glutamate. Each patient will serve as her/his own control. Results will be analysed by pair-T test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| With monosodium glutamate | Other | Dietary Supplement: Monosodium glutamateResults of one time gastric emptying study with a single dose of monosodium glutamate; 1 g for weight greater than 45 kg, 700mg between 35 and 44,900 kg, 600mg between 25 and 34,900, 500mg between 15 and 25 kg and 250mg in less than 15 kg |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with delayed gastric emptying not receiving prokinetic medication in the last 72 hours
Key exclusion criteria (1 listed)
- Prior gastrointestinal surgery, patients with known history of reaction to monosodium glutamate. History of neoplasia, autoimmune or inflammatory bowel disease.
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 |
|---|---|---|
| Monosodium glutamateA single dose of weight adjusted monosodium glutamate will be added at the time of a repeat radionuclide gastric emptying study | Dietary supplement | With monosodium glutamate |
Primary outcome
Reduced gastric emptying time
Time frame: During the test (4 hours from intake)
Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Results publication: PubMed 24744869Teramoto H, Shimizu T, Yogo H, Nishimiya Y, Hori S, Kosugi T, Nakayama S. Gastric emptying and duodenal motility upon intake of a liquid meal with monosodium glutamate in healthy subjects. Physiol Rep. 2014 Jan 6;2(1):e00187. doi: 10.1002/phy2.187. eCollection 2014 Jan 1.
- Results publication: PubMed 19056566Zai H, Kusano M, Hosaka H, Shimoyama Y, Nagoshi A, Maeda M, Kawamura O, Mori M. Monosodium L-glutamate added to a high-energy, high-protein liquid diet promotes gastric emptying. Am J Clin Nutr. 2009 Jan;89(1):431-5. doi: 10.3945/ajcn.2008.26180. Epub 2008 Dec 3.
- Results publication: PubMed 21030612Boutry C, Matsumoto H, Airinei G, Benamouzig R, Tome D, Blachier F, Bos C. Monosodium glutamate raises antral distension and plasma amino acid after a standard meal in humans. Am J Physiol Gastrointest Liver Physiol. 2011 Jan;300(1):G137-45. doi: 10.1152/ajpgi.00299.2010. Epub 2010 Oct 28.
- Results publication: PubMed 22978669Hosaka H, Kusano M, Zai H, Kawada A, Kuribayashi S, Shimoyama Y, Nagoshi A, Maeda M, Kawamura O, Mori M. Monosodium glutamate stimulates secretion of glucagon-like peptide-1 and reduces postprandial glucose after a lipid-containing meal. Aliment Pharmacol Ther. 2012 Nov;36(9):895-903. doi: 10.1111/apt.12050.
- Questions and Answers on Monosodium glutamateLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Veronica B Busoni, MD principal investigator
Hospital Italiano de Buenos Aires
Questions about this trial
What is this clinical trial studying?
A study testing Monosodium glutamate in people with Delayed Gastric Emptying, run by Veronica Beatriz Busoni.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Reduced gastric emptying time (time frame: During the test (4 hours from intake)). 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 NCT02745028, which also lists 4 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 2 Mar 2023.