NCT02125851

Brief Summary

The purpose of this study is to determine if a xanthan gum or honey based budesonide slurry exhibit comparable mucosal contact time to a budesonide/sucralose slurry in healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
Last Updated

April 29, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

February 21, 2014

Last Update Submit

April 25, 2014

Conditions

Eosinophilic Esophagitis

Keywords

slurrysplendasucralosebudesonidemucosal contact time

Outcome Measures

Primary Outcomes (1)

  • Esophageal Mucosal Contact Time

    Comparison of esophageal contact time of sucralose slurry vs either honey slurry or xanthan gum based slurry. 1 hour will elapse between ingestions.

    1 hour

Secondary Outcomes (1)

  • Taste preference

    1 minute after slurry is ingested

Study Arms (2)

Xanthan Gum

EXPERIMENTAL

A total of 12 subject will be administered sucralose slurry and the xanthan gum slurry. Six will get sucralose first (then an hour later the xanthan gum) and 6 will receive the xanthan gum first (then an hour later the sucralose slurry). The sucralose slurry will which will consist of a 1mg dose of budesonide inhalation solution (respule) mixed with 10 grams of sucralose and 1 millicurie (mCi) of Tc99m-Sulfur Colloid. The xanthan gum-budesonide slurry will consist of a 1mg dose of budesonide inhalation solution (respule) mixed with 1ml of xanthan gum gel, crystallized orange flavoring agent, and 1mCi of Tc99-Sulfur colloid.

Other: Xanthan Gum

Honey

EXPERIMENTAL

A total of 12 subject will be administered sucralose slurry and the honey slurry. Six will get sucralose first (then an hour later the honey) and 6 will receive the honey first (then an hour later the sucralose slurry). The sucralose slurry will which will consist of a 1mg dose of budesonide inhalation solution (respule) mixed with 10 grams of sucralose and 1 millicurie (mCi) of Tc99m-Sulfur Colloid. The honey-budesonide slurry will consist of a 1mg dose of budesonide inhalation solution (respule) mixed with 6ml of honey and 1mCi of Tc99-Sulfur Colloid.

Other: Honey

Interventions

Xanthan GumOTHER

esophageal mucosal contact time vs sucralose slurry

Xanthan Gum
HoneyOTHER

esophageal mucosal contact time of honey vs sucralose slurry

Honey

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DEERS eligible
  • Older than 18 y/o, without diagnosis of Eosinophilic Esophagitis or other esophageal disease

You may not qualify if:

  • History of EoE, esophageal surgery or known achalasia/stricture or previously diagnosed GERD or GER that requires more frequent than once a week treatment.
  • Peripheral eosinophil count above 0.5 X10\^3 / mcL.
  • Pregnancy or breastfeeding
  • Previous adverse reaction to budesonide, honey, or oranges.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

  • Dellon ES, Sheikh A, Speck O, Woodward K, Whitlow AB, Hores JM, Ivanovic M, Chau A, Woosley JT, Madanick RD, Orlando RC, Shaheen NJ. Viscous topical is more effective than nebulized steroid therapy for patients with eosinophilic esophagitis. Gastroenterology. 2012 Aug;143(2):321-4.e1. doi: 10.1053/j.gastro.2012.04.049. Epub 2012 May 3.

    PMID: 22561055BACKGROUND

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

xanthan gumHoney

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jody N Hefner, DO

    Walter Reed National Military Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2014

First Posted

April 29, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 29, 2014

Record last verified: 2014-03

Locations

US(1)