Monosodium Glutamate on Gastric Emptying

February 28, 2023 updated by: Veronica Beatriz Busoni

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: With monosodium glutamate
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
A single dose of weight adjusted monosodium glutamate will be added at the time of a repeat radionuclide gastric emptying study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the test (4 hours from intake)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veronica Beatriz Busoni

Collaborators

International Glutamate Technical Committee

Investigators

  • Principal Investigator: Veronica B Busoni, MD, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The participant data to be shared will be the results of the 2nd radionuclide gastric emptying test in comparison to the first abnormal test.

The data will be entered once a month and it will be obtained from the Nuclear Medicine Unit

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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