Elemental Diets vs. Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation

Gastro-oesophageal Reflux Clinical Trial

Official title:

Randomized Comparison of Elemental Diets and Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation in Bedridden Gastrostomy-fed Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02290626
• Other study ID #: ED vs. Semi-solid
• Status: Withdrawn
• Phase: N/A
• First received: November 2, 2014
• Last updated: October 30, 2015
• Start date: November 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2015
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Study 1: A randomized, crossover trial using elemental or semi-solid diets containing contrast medium as a tracer given to bedridden PEG patients. The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration.

Study 2: A randomized, crossover trial using elemental or semi-solid diets containing 13C sodium acetate as a tracer given to bedridden PEG patients. 13C breath tests are performed to estimate gastric emptying.

Description:

Study 1: A mix of elemental or semi-solid diet (300 kcal/300 mL ) and contrast medium (5ml) is administered using PEG, respectively. Using a plain CT, the distribution of the administered diet is assessed at the distal esophagus, proximal and distal stomach before and 1 hour after the administration. The volume of the residual diet at the distal esophagus, proximal and distal stomach is compared between an elemental and semi-solid diet.

Study 2: Either the elemental diet or semi-solid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate (Cambridge Isotope Laboratories Inc, Cambridge, MA) and is administered in the first 15 min of the examination at the same speed using the PEG.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Bedridden PEG patients are admitted for fever which is the most common reason for admission of PEG patients to our hospital.

Exclusion Criteria:

• Regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastro-oesophageal Reflux
• Gastroesophageal Reflux

Intervention

Drug:
• Elmental diet
elemental diet is administered using PEG.
• Semi-solid diet
Semi-solid diet is administered using PEG.

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroesophageal regurgitation	The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration.	A half year	Yes
Secondary	Gastric excretion	13C breath tests were performed to estimate gastric excretion.	A half year	Yes