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

Not Applicable

Withdrawn

• Conditions: Gastro-oesophageal Reflux
• Interventions: Drug: Elmental diet; Drug: Semi-solid diet

• Registration Number: NCT02290626
• Lead Sponsor: Showa Inan General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-02
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-03
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: WITHDRAWN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

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Elemental diet	Elmental diet	Study 1: Elemental diet (300 kcal/300 ml) containing a contrast medium (5 ml) is administered within 15 min using the PEG. Study 2: Elemental diet (200 kcal/200 mL) labeled with 100 mg \[13C\]sodium acetate is administered within 15 min using the PEG.
Semi-solid diet	Semi-solid diet	Study 1: Semi-solid diet (300 kcal/300 ml) containing a contrast medium (5 ml) is administered within 15 min using the PEG. Study 2: Semi-solid diet (200 kcal/200 mL) labeled with 100 mg \[13C\]sodium acetate is administered within 15 min using the PEG.

Primary Outcome Measures

Name	Time	Method
Gastroesophageal regurgitation	A half year	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.

Secondary Outcome Measures

Name	Time	Method
Gastric excretion	A half year	13C breath tests were performed to estimate gastric excretion.

Trial Locations

Locations (1)

Showa Inan General Hospital; 🇯🇵 Komagane, Japan