DiarrheaPhase 4NCT01467570
Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis
A Phase 4 study testing oral rehydration solution Hipp ORS Apple 200 and ESPGHAN ORS in people with Diarrhea, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 48 months
- Conditions the study is for
- Diarrhea
- What is being tested?
- oral rehydration solution Hipp ORS Apple 200 and ESPGHAN ORS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Peadiatrics, The Medical University of Warsaw
Warsaw, 01-183
About this study
Official title: Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis: Randomized, Double-Blind Controlled Trial
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).
Read the detailed description
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). Despite the proven efficacy of oral rehydration therapy it remains underused. The main reason for this is that an ORS neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness, which decreases its acceptance. Moreover, unpalatability of regular ORS decrease its acceptance, especially in children with lower degrees of dehydration. Refusal to drink regular ORS interfere with compliance with the recommended treatment. Parents, but also health care professionals, demand safe, effective, inexpensive, but also well tolerated and accepted ORS for management of AGE.
Recently, a new ORS (Hipp ORS 200 Apple) with improved taste has been developed, and is now frequently employed for the management of AGE. The proposed study will be the first double-blind randomized trial of this ORS. It will evaluate clinically meaningful benefits to be derived by children and caregivers from its use. If positive, this new ORS may become a routine recommendation for children with AGE.
The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) with regular ORS recommended by ESPGHAN in children with AGE.
- Conditions
- Diarrhea
- Being tested
- oral rehydration solution Hipp ORS Apple 200, ESPGHAN ORS
- Keywords
- diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral rehydration solution Hipp ORS Apple 200Dietary 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 ORSDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| Hipp ORS Apple 200 | Experimental | oral rehydration solution Hipp ORS 200 Apple Receives: Dietary Supplement: oral rehydration solution Hipp ORS Apple 200 |
| ESPGHAN ORS | Active comparator | ESPGHAN oral rehydration solution Receives: Dietary Supplement: ESPGHAN ORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Proportion of successfully rehydrated at 24 hours
Secondary outcomes (9)
Unscheduled Intravenous Therapy
Need for intravenous therapy within 24 hours
Measured: 24 hours
Vomiting
Vomiting starting or progressing in the first 24 hours of therapy
Measured: 24 hours
ORS Intake in ml
ORS intake in ml (in the first 24 hours, and total)
Measured: 24 hours
Weight Gain in Gram
Weight gain in gram (in the first 24 hours, and total)
Measured: 24 hours
Duration of Diarrhea (Hrs)
Time of diarrhea in hours
Measured: 7days
Return Visit to the Emergency Department
Return visit to the emergency department within a week
Measured: 1 week
Hospitalization
need for hospitalization within a week
Measured: 1 week
Adverse Events
any adverse event, providing a description if related or not related to study intervention
Measured: 24 hours
ORS Intake at 4 h
% of prescribed ORS that was consumed during first 4 hours
Measured: 4 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hania Szajewska, Professor, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467570
- Sponsor's protocol ID
- KB/191/2008
- Status last verified
- Nov 2013
- First submitted
- 27 Oct 2011
- Last updated
- 1 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 18493225Recommendations 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.
PubMed 1573500Szajewska 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.
PubMed 10817282Piescik-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.
PubMed 22860693
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis: Randomized, Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01467570
- Acronym / sponsor ID
- KB/191/2008
- Conditions
- Diarrhea
- Keywords
- diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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). Despite the proven efficacy of oral rehydration therapy it remains underused. The main reason for this is that an ORS neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness, which decreases its acceptance. Moreover, unpalatability of regular ORS decrease its acceptance, especially in children with lower degrees of dehydration. Refusal to drink regular ORS interfere with compliance with the recommended treatment. Parents, but also health care professionals, demand safe, effective, inexpensive, but also well tolerated and accepted ORS for management of AGE.
Recently, a new ORS (Hipp ORS 200 Apple) with improved taste has been developed, and is now frequently employed for the management of AGE. The proposed study will be the first double-blind randomized trial of this ORS. It will evaluate clinically meaningful benefits to be derived by children and caregivers from its use. If positive, this new ORS may become a routine recommendation for children with AGE.
The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) with regular ORS recommended by ESPGHAN in children with AGE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hipp ORS Apple 200 | Experimental | Dietary Supplement: oral rehydration solution Hipp ORS Apple 200oral rehydration solution Hipp ORS 200 Apple |
| ESPGHAN ORS | Active comparator | Dietary Supplement: ESPGHAN ORSESPGHAN oral rehydration solution |
Who may qualify
- Ages
- 4 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral rehydration solution Hipp ORS Apple 200Volume 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) | Dietary supplement | Hipp ORS Apple 200 |
| ESPGHAN ORSVolume 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) | Dietary supplement | ESPGHAN ORS |
Primary outcome
Number of Participants That Were Successfully Rehydrated
Time frame: Proportion of successfully rehydrated at 24 hours
The following components are included in primary outcome: * resolution of signs of dehydration * adequate weight gain * production of urine output during the trial
9 secondary outcomes
Unscheduled Intravenous Therapy
Time frame: 24 hours
Vomiting
Time frame: 24 hours
ORS Intake in ml
Time frame: 24 hours
Weight Gain in Gram
Time frame: 24 hours
Duration of Diarrhea (Hrs)
Time frame: 7days
Return Visit to the Emergency Department
Time frame: 1 week
Hospitalization
Time frame: 1 week
Adverse Events
Time frame: 24 hours
ORS Intake at 4 h
Time frame: 4 hrs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18493225Guarino 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.
- Background: PubMed 1573500Recommendations 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.
- Background: PubMed 10817282Szajewska 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.
- Derived from this study: PubMed 22860693Piescik-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hania Szajewska, Professor principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral rehydration solution Hipp ORS Apple 200 and ESPGHAN ORS in people with Diarrhea, run by Medical University of Warsaw at 1 site in Poland.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Were Successfully Rehydrated (time frame: Proportion of successfully rehydrated at 24 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 NCT01467570, which also lists 4 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 1 Apr 2014; AzTrials last refreshed its copy on 7 Nov 2026.