Monosodium Glutamate on Gastric Emptying

Not Applicable

Withdrawn

• Conditions: Delayed Gastric Emptying
• Interventions: Dietary Supplement: Monosodium glutamate

• Registration Number: NCT02745028
• Lead Sponsor: Veronica Beatriz Busoni

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.

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
With monosodium glutamate	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

Primary Outcome Measures

Name	Time	Method
Reduced gastric emptying time	During the test (4 hours from intake)	Percentage of reduction of gastric emptying time when glutamate is administered compared to baseline