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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastro-oesophageal Reflux

Intervention / Treatment
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* Drug: Elmental diet
* Drug: Semi-solid diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elemental diet<br>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. | Drug: Elmental diet<br>* elemental diet is administered using PEG.<br>* Other names: Elental;|
| Active Comparator: Semi-solid diet<br>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. | Drug: Semi-solid diet<br>* Semi-solid diet is administered using PEG.<br>* Other names: Racol-NF semisolid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric excretion | 13C breath tests were performed to estimate gastric excretion. | A half year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elemental diet, semi-solid diet, gastric emptying, GER, PEG