Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290626
Recruitment Status : Withdrawn (Study protocol was changed.)
First Posted : November 14, 2014
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, 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.


Condition or disease Intervention/treatment Phase
Gastro-oesophageal Reflux Drug: Elmental diet Drug: Semi-solid diet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Elemental Diets and Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation in Bedridden Gastrostomy-fed Patients
Study Start Date : November 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Elemental 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.

Drug: Elmental diet
elemental diet is administered using PEG.
Other Name: Elental

Active Comparator: 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.

Drug: Semi-solid diet
Semi-solid diet is administered using PEG.
Other Name: Racol-NF semisolid




Primary Outcome Measures :
  1. Gastroesophageal regurgitation [ Time Frame: 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 :
  1. Gastric excretion [ Time Frame: A half year ]
    13C breath tests were performed to estimate gastric excretion.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290626


Locations
Layout table for location information
Japan
Showa Inan General Hospital
Komagane, Japan, 399-4191
Sponsors and Collaborators
Showa Inan General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Akira Horiuchi, MD Showa Inan General Hospital
Layout table for additonal information
Responsible Party: Akira Horiuchi, Chief, Digestive Disease Center, Showa Inan General Hospital
ClinicalTrials.gov Identifier: NCT02290626    
Other Study ID Numbers: ED vs. Semi-solid
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015
Keywords provided by Akira Horiuchi, Showa Inan General Hospital:
Elemental diet
semi-solid diet
gastric emptying
GER
PEG
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases