Gastro-oesophageal Reflux
Conditions
Keywords
Elemental diet, semi-solid diet, gastric emptying, GER, PEG
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.
Interventions
DRUGElmental diet
elemental diet is administered using PEG.
DRUGSemi-solid diet
Semi-solid diet is administered using PEG.
Sponsors
Showa Inan General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Gastric excretion | A half year | 13C breath tests were performed to estimate gastric excretion. |
Countries
Japan
Outcome results
None listed