Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis

NCT01467570 | Completed Phase 4 Results DMC

• 1 other identifier: KB/191/2008
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended treatment. The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN in children with acute gastroenteritis (AGE).

Conditions

Diarrhea

Keywords

diarrhea

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Were Successfully Rehydrated

  The following components are included in primary outcome: * resolution of signs of dehydration * adequate weight gain * production of urine output during the trial

  Proportion of successfully rehydrated at 24 hours

Secondary Outcomes (9)

• Unscheduled Intravenous Therapy

  24 hours

• Vomiting

  24 hours

• ORS Intake in ml

  24 hours

• Weight Gain in Gram

  24 hours

• Duration of Diarrhea (Hrs)

  7days

Study Arms (2)

Hipp ORS Apple 200

EXPERIMENTAL

oral rehydration solution Hipp ORS 200 Apple

Dietary Supplement: oral rehydration solution Hipp ORS Apple 200

ESPGHAN ORS

ACTIVE COMPARATOR

ESPGHAN oral rehydration solution

Dietary Supplement: ESPGHAN ORS

Interventions

oral rehydration solution Hipp ORS Apple 200 DIETARY_SUPPLEMENT

Volume of the solution calculated by weight: * fast oral rehydration in 3-4 hours by mouth * ORS given for ongoing losses until diarrhea stops (maintenance phase)

Hipp ORS Apple 200

ESPGHAN ORS DIETARY_SUPPLEMENT

Volume of the solution calculated by weight: * fast oral rehydration in 3-4 hours by mouth * ORS given for ongoing losses until diarrhea stops (maintenance phase)

ESPGHAN ORS

Eligibility Criteria

• Age: 4 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children age 4 to 48 months
• diarrhoea defined as the passage of three or more loose or watery stools per day for \>1 but \<5 days
• mild (3%) or moderate dehydration (3-9%) according to the World Health Organization criteria (Table 1)
• informed consent signed by at least one parent / caregiver

You may not qualify if:

• diarrhea for \<1 or \>5 days
• severe dehydration (\>9%)
• recent history of diarrhea indicated either by parent/guardian or hospital case notes
• underlying chronic gastrointestinal disease (i.e., celiac disease, cow's milk protein intolerance)
• breastfeeding \>50%
• under nutrition (weight/height ratio below the fifth percentile)
• systemic infections
• immune defects or immunosuppressive treatment

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Peadiatrics, The Medical University of Warsaw

Warsaw, 01-183, Poland

Location

Related Publications (4)

• Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available.

  PMID: 18493225 BACKGROUND

• Recommendations for composition of oral rehydration solutions for the children of Europe. Report of an ESPGAN Working Group. J Pediatr Gastroenterol Nutr. 1992 Jan;14(1):113-5. No abstract available.

  PMID: 1573500 BACKGROUND

• Szajewska H, Hoekstra JH, Sandhu B; ESPGHAN Working Group on Acute Diarrhoea. Management of acute gastroenteritis in Europe and the impact of the new recommendations: a multicenter study. The Working Group on acute Diarrhoea of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2000 May;30(5):522-7. doi: 10.1097/00005176-200005000-00011.

  PMID: 10817282 BACKGROUND

• Piescik-Lech M, Szymanski H, Szajewska H. Efficacy and safety of a new apple-flavoured oral rehydration solution in children with acute gastroenteritis: a double-blind randomized controlled trial. Acta Paediatr. 2012 Oct;101(10):e458-64. doi: 10.1111/j.1651-2227.2012.02782.x. Epub 2012 Aug 3.

  PMID: 22860693 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Potential limitations included lack of perfect blinding. Because of technological reasons, it was not feasible to produce study products that were identical in colour, smell and taste.

Results Point of Contact

• Title: Hanna Szajewska, Malgorzata Piescik-Lech
• Organization: The Medical University of Warsaw

hania@ipgate.pl

+48-22-45-23-309

Study Officials

• Hania Szajewska, Professor

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 8, 2011
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 1, 2014
• Results First Posted: April 1, 2014

Record last verified: 2013-11

Locations

PL (1)