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

NCT ID: NCT02290626

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-31

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.

Conditions

Gastro-oesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Elmental diet

Intervention Type: DRUG

elemental diet is administered using PEG.

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.

Group Type: ACTIVE_COMPARATOR

Semi-solid diet

Intervention Type: DRUG

Semi-solid diet is administered using PEG.

Interventions

Elmental diet

elemental diet is administered using PEG.

Intervention Type: DRUG

Semi-solid diet

Semi-solid diet is administered using PEG.

Intervention Type: DRUG

Other Intervention Names

Elental; Racol-NF semisolid

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Showa Inan General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Akira Horiuchi

Chief, Digestive Disease Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akira Horiuchi, MD

Role: PRINCIPAL_INVESTIGATOR

Showa Inan General Hospital

Locations

Showa Inan General Hospital

Komagane, , Japan

Countries

Japan

Other Identifiers

ED vs. Semi-solid

Identifier Type: -

Identifier Source: org_study_id