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

NCT02290626 | Withdrawn

• 1 other identifier: ED vs. Semi-solid
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-oesophageal Reflux

Keywords

Elemental diet; semi-solid diet; gastric emptying; GER; PEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gastric excretion

  A half year

Study Arms (2)

Elemental diet

EXPERIMENTAL

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

Semi-solid diet

ACTIVE COMPARATOR

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

Interventions

Elmental diet DRUG

elemental diet is administered using PEG.

Also known as: Elental

Elemental diet

Semi-solid diet DRUG

Semi-solid diet is administered using PEG.

Also known as: Racol-NF semisolid

Semi-solid diet

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bedridden PEG patients are admitted for fever which is the most common reason for admission of PEG patients to our hospital.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Showa Inan General Hospital: lead

Study Sites (1)

Showa Inan General Hospital

Komagane, 399-4191, Japan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Akira Horiuchi, MD

  Showa Inan General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Digestive Disease Center

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: November 14, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 3, 2015

Record last verified: 2015-10

Locations

JP (1)