NCT02290626

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Showa Inan General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastro-oesophageal Reflux

Interventions

Type	Name	Description
DRUG	Elmental diet	elemental diet is administered using PEG.
DRUG	Semi-solid diet	Semi-solid diet is administered using PEG.

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-11-14
• Last updated: 2015-11-03

Locations

1 site across 1 country: Japan