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Gastrointestinal InfectionsNCT02729870

Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

An observational study of Gastrointestinal Infections and Ketosis, run by University of Florida.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The investigators investigate oral glucose gel for its effectiveness in rapidly reducing ketoacidosis and for improvements in oral hydration therapy success. Read more about this study

Who is it for?
Ages 1 year to 7 years
Conditions the study is for
Gastrointestinal Infections, Ketosis
What is being tested?
Oral Glucose Gel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2018to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 7 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children aged 1-7 years presenting to ED with symptoms of gastroenteritis

Who may be able to join

  • Participants with gastroenteritis presenting to UF Health Shands Emergency Department

Who cannot join

  • hypoglycemic- Blood glucose less than 50 or hyperglycemic- greater than 200

About this study

Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The investigators investigate oral glucose gel for its effectiveness in rapidly reducing ketoacidosis and for improvements in oral hydration therapy success.

Read the detailed description

More than 1.7 million children with acute gastroenteritis present for emergency department (ED) care annually in the United States. Gastroenteritis treatment regimens have been outlined in guidelines endorsed by the American Academy of Pediatrics, European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN), and Center for Disease Control (CDC). A fundamental principle included in these guidelines is the administration of oral rehydration therapy (ORT) to the vast majority of children with gastroenteritis; however, surveys have shown that a gap exists between guidelines and practice. Fasting ketoacidosis is an increasingly recognized metabolic derangement for children presenting with symptoms suggestive of gastroenteritis and mild to moderate dehydration. Ketoacidosis frequently occurs and likely adds comorbid symptoms of lethargy, vomiting, and malaise. These symptoms likely impair successful oral rehydration interventions. These symptoms may also lead to overestimations of the severity of dehydration. Rapid recognition of ketoacidosis is now possible with point of care testing beta-hydroxybutyrate. This investigation will determine if an oral glucose gel intervention will improve the Point Of Care (POC) beta-hydroxybutyrate from baseline. Secondary outcomes measured will include net fluid volume intake estimates, need for IV hydration, and need for hospitalization.

Being tested
Oral Glucose Gel, Placebo
Keywords
Ketones, Gastroenteritis
Medical subject headings
Ketosis, Gastroenteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Glucose GelDrug

    Also called Dextrose Gel, Glucote

    This group will receive the following: are less than 3 year of age will receive 7.5 gram oral glucose gel 40% (0.66 oz, 20ml) which will be a one time dose and the subjects who are ages 3-7 will receive 15 gram oral glucose gel (1.3 oz, 40ml) which is a one time dose.

  • PlaceboOther

    Also called carboxymethylcellulose (2%) oral gel

    This group will receive carboxymethylcellulose (2%) oral gel. The subjects who are less than than 3 years of age will receive carboxymethylcellulose (2%) oral gel, 20ml which will be a one time dose and the subjects ages 3-7 will receive carboxymethylcellulose (2%) oral gel, 40ml which will be a one time dose.

Study groups in NCT02729870
Study groupRoleWhat they receive
Oral Glucose GelThis group will consist of participants ages 1 - 7. The subject who are less than 3 year of age will receive 7.5 gram oral glucose gel 40% (0.66 oz, 20ml) which will be a one time dose and the subjects who are ages 3-7 will receive 15 gram oral glucose gel (1.3 oz, 40ml) which is a one time dose.
Receives: Drug: Oral Glucose Gel
Oral Placebo GelThe group will consist of participants ages 1 - 7. The subjects who are less than 3 years of age will receive carboxymethylcellulose (2%) oral gel, 20ml which will be a one time dose and the subjects ages 3- 7 will receive carboxymethylcellulose (2%) oral gel, 40ml which will be a one time dose.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Beta-hydroxybutyrate will be analyzed between the groups

    Change in beta-hydroxybutyrate will be measured by blood test from -0 hour to 4 hours between the groups.

    Measured: Change from baseline to 4 hours

Secondary outcomes (3)

  1. The amount of oral fluid intake in milliliters will be measured between the groups

    Oral fluid consumption will be measured between the groups.

    Measured: Change from 1 hour to 4 hours

  2. Number of subjects Intravenous (IV)-Hydration between the groups

    Oral fluid hydration will have failed if subject needs IV fluid.

    Measured: 4 hours

  3. Number of subjects hospitalized between the groups

    The number of subjects with successful hydration can go home, however, the number of subjects who have to be hospitalized between the groups will be noted.

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startJan 2018 (estimated)
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Why it stopped: lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02729870
Sponsor's protocol ID
IRB201600147
Status last verified
Jan 2018
First submitted
29 Mar 2016
Last updated
29 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Practice parameter: the management of acute gastroenteritis in young children. American Academy of Pediatrics, Provisional Committee on Quality Improvement, Subcommittee on Acute Gastroenteritis. Pediatrics. 1996 Mar;97(3):424-35.

    PubMed 8604285

  • Freedman SB, Steiner MJ, Chan KJ. Oral ondansetron administration in emergency departments to children with gastroenteritis: an economic analysis. PLoS Med. 2010 Oct 12;7(10):e1000350. doi: 10.1371/journal.pmed.1000350.

    PubMed 20967234

  • King CK, Glass R, Bresee JS, Duggan C; Centers for Disease Control and Prevention. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm Rep. 2003 Nov 21;52(RR-16):1-16.

    PubMed 14627948

  • Whyte LA, Al-Araji RA, McLoughlin LM. Guidelines for the management of acute gastroenteritis in children in Europe. Arch Dis Child Educ Pract Ed. 2015 Dec;100(6):308-12. doi: 10.1136/archdischild-2014-307253. Epub 2015 May 4. No abstract available.

    PubMed 25939578

  • Freedman SB, Gouin S, Bhatt M, Black KJ, Johnson D, Guimont C, Joubert G, Porter R, Doan Q, van Wylick R, Schuh S, Atenafu E, Eltorky M, Cho D, Plint A; Pediatric Emergency Research Canada. Prospective assessment of practice pattern variations in the treatment of pediatric gastroenteritis. Pediatrics. 2011 Feb;127(2):e287-95. doi: 10.1542/peds.2010-2214. Epub 2011 Jan 24.

    PubMed 21262881

  • Freedman SB, Thull-Freedman JD, Rumantir M, Atenafu EG, Stephens D. Emergency department revisits in children with gastroenteritis. J Pediatr Gastroenterol Nutr. 2013 Nov;57(5):612-8. doi: 10.1097/MPG.0b013e3182a1dd93.

    PubMed 23820403

  • Levy JA, Bachur RG, Monuteaux MC, Waltzman M. Intravenous dextrose for children with gastroenteritis and dehydration: a double-blind randomized controlled trial. Ann Emerg Med. 2013 Mar;61(3):281-8. doi: 10.1016/j.annemergmed.2012.08.007. Epub 2012 Sep 6.

    PubMed 22959318

  • Reid SR, Losek JD. Rehydration: role for early use of intravenous dextrose. Pediatr Emerg Care. 2009 Jan;25(1):49-52; quiz 53-4. doi: 10.1097/PEC.0b013e318191d97c.

    PubMed 19148016

  • Levy JA, Waltzman M, Monuteaux MC, Bachur RG. Value of point-of-care ketones in assessing dehydration and acidosis in children with gastroenteritis. Acad Emerg Med. 2013 Nov;20(11):1146-50. doi: 10.1111/acem.12256.

    PubMed 24238317

  • Harris DL, Weston PJ, Signal M, Chase JG, Harding JE. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Dec 21;382(9910):2077-83. doi: 10.1016/S0140-6736(13)61645-1. Epub 2013 Sep 25.

    PubMed 24075361

  • Barennes H, Valea I, Nagot N, Van de Perre P, Pussard E. Sublingual sugar administration as an alternative to intravenous dextrose administration to correct hypoglycemia among children in the tropics. Pediatrics. 2005 Nov;116(5):e648-53. doi: 10.1542/peds.2004-2218.

    PubMed 16263979

Questions about this trial

What is this clinical trial studying?

An observational study of Gastrointestinal Infections and Ketosis, run by University of Florida.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beta-hydroxybutyrate will be analyzed between the groups (time frame: Change from baseline to 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02729870, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.

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