NCT02745028

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2016

Status
withdrawn

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

April 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

April 7, 2016

Last Update Submit

February 28, 2023

Conditions

Delayed Gastric Emptying

Keywords

delayed gastric emptyingchildrenmonosodium glutamate

Outcome Measures

Primary Outcomes (1)

  • Reduced gastric emptying time

    Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline

    During the test (4 hours from intake)

Study Arms (1)

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

Dietary Supplement: Monosodium glutamate

Interventions

Monosodium glutamateDIETARY_SUPPLEMENT

A single dose of weight adjusted monosodium glutamate will be added at the time of a repeat radionuclide gastric emptying study

With monosodium glutamate

Eligibility Criteria

Age12 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with delayed gastric emptying not receiving prokinetic medication in the last 72 hours

You may not qualify if:

  • Prior gastrointestinal surgery, patients with known history of reaction to monosodium glutamate. History of neoplasia, autoimmune or inflammatory bowel disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 24744869RESULT

  • Zai 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.

    PMID: 19056566RESULT

  • Boutry 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.

    PMID: 21030612RESULT

  • Hosaka 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.

    PMID: 22978669RESULT

Related Links

MeSH Terms

Conditions

Gastroparesis

Interventions

Sodium Glutamate

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glutamic AcidGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Veronica B Busoni, MD

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the Pediatric Gastroenterology and Hepatology Service

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 20, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

March 2, 2023

Record last verified: 2023-02