Acute GastroenteritisNCT01886755
Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis
A study testing ORS rehydration solution in people with Acute Gastroenteritis, run by Alexandra Papadopoulou at 1 site in Greece.
Trial summary
An ORS with L. reuteri DSM 17938 and zinc is expected to reduce duration and severity of symptoms in infants and young children with acute gastroenteritis. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- ORS rehydration solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2013to Dec 2015
- Phase
- Interventional
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 - 36 months old children
- 3 or more watery or soft stools per day for the past 24-48 hours
- Clinically judged as having mild to moderate dehydration (Bailey scale scores 1 to 4)
- Available throughout the study period
- Re-examination on the 7th day from the enrolment
- The signed informed consent by one/both parents or legal guardian
- Parents or legal guardian should have the mental ability to understand and willingness to fulfil all the details of the protocol
Who cannot join
- Diarrhoea lasting more than 48 h
- Clinical signs of severe dehydration (Bailey scale scores = or > 5)
- Malnutrition as judged by a body weight/height ratio below the 5th percentile
- Clinical signs of a coexisting severe acute systemic illness (meningitis, sepsis, pneumonia)
- Immunodeficiency
- Severe chronic disease including cystic fibrosis
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- Food allergy diagnosed by physician or other chronic gastrointestinal diseases
- Use of pre-/probiotics in the previous 2 weeks, for example infant formula containing probiotics and/or prebiotics.
- Use of antibiotics or any anti-diarrhoeal medication in the previous 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
An ORS with L. reuteri DSM 17938 and zinc is expected to reduce duration and severity of symptoms in infants and young children with acute gastroenteritis.
Read the detailed description
Oral rehydration solution is recommended for treatment and prevention of dehydration due to acute gastroenteritis in infants and children (WHO/UNICEF, 2004; ESPGHAN / ESPID Guidelines, 2008). Acute diarrhoea may lead to zinc depletion in infants, and zinc supplementation is recommended in infants and children with acute gastroenteritis living in developing countries. In developed countries however, the studies on the efficacy of zinc supplementation in children with acute gastroenteritis are few and conflicting.
Selected strains of probiotics, including L. reuteri ATCC 55730, have been shown in several studies to reduce the duration and the severity of diarrhoea in children with acute gastroenteritis and the effect is greater if the probiotics are given within 60 hours from the onset of symptoms. Lactobacillus reuteri (L. reuteri) has been shown to reduce the duration and severity of acute gastroenteritis in children aged 6-36 months. In these studies L. reuteri was reported to have clinical effect on diarrhoea of both bacterial and viral (rotavirus) origin. Furthermore, L. reuteri strain DSM 17938 has recently been shown to reduce the duration of watery diarrhoea by 1.2 days among 6-36 mo old Italian children with acute gastroenteritis treated in hospital.
The present study is a prospective, randomized, double blind, controlled study with parallel groups. The planned investigation is designed to compare the efficacy of an ORS with L. reuteri DSM 17938 and zinc to an ORS with similar osmolarity and content of salts but without L. reuteri DSM 17938 and zinc, on the duration and severity of acute gastroenteritis. 92 children aged 6-36 months seen at private pediatric clinics and/or at the emergency clinics of the Athens Childrens Hospital "AGIA SOPHIA", and treated either as outpatients or as inpatients will be recruited until the final sample size is reached. Assuming a difference of 30% between groups in the primary outcome of prevalence of diarrhoea on day 2, and estimating an attrition rate of approximately 15%, the final sample size will be 92 subjects, or 46 subjects in each arm.
Data collection points will be on day 7 at the outpatient clinic of the Division of Pediatric Gastroenterology \& Nutrition of the First Department of Paediatrics, Athens University Hospital.
- Conditions
- Acute Gastroenteritis
- Being tested
- ORS rehydration solution, placebo
- Keywords
- Acute gastroenteritis, Probiotics, Lactobacillus reuteri, Zinc supplementation, Infants, Age 6 months to 36 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORS rehydration solutionDietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| ORS with probiotic and zinc | Experimental | ORS with probiotic and zinc Oral rehydration solution with freeze-dried Lactobacillus reuteri DSM 17938 and zinc sulphate Receives: Dietary Supplement: ORS rehydration solution |
| Placebo Comparator | Placebo comparator | Standard oral rehydration solution Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of diarrhoea.
- Proportion of children without watery (3A ISS by Amsterdam infant stool scale ) or soft (3B ISS Amsterdam infant stool scale) stools on day 2 of treatment. Day 0 = day of enrolment and start of treatment, day 1 = first complete day of treatment
- Time from start of treatment and until last watery or soft stool.
Measured: 48 hrs after start of treatment
Secondary outcomes (1)
Reduction of severity of diarrhoea
Reduction of severity of diarrhoea will be evaluated as though :
- Number of watery (type 3A ISS ) and soft ( 3B ISS) stools daily on each of the day of the therapy and up to 5 days.
- Proportion of children with watery (3A ISS) and soft ( 3B ISS) stools on each of the day 1-5 (Day 0 = day of enrolment and start of treatment, day 1 = first complete day of treatment)
- Νumber of vomiting episodes: per child on each of the treatment days 1-5.
- Volume of ORS intake during the first 24h of treatment.
- Need of hospitalization
- Absence of workdays for the parents.
- Child's absence from day care / nursery.
- Medication needed for treatment of diarrhoea.
Measured: 120 hrs from the start on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandra Papadopoulou
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Sponsor-investigator, Alexandra Papadopoulou, Aghia Sophia Children's Hospital of Athens
- Investigators
- Alexandra Papadopoulou, Dr, Principal investigator, Athens Children's Hospital "AGIA SOPHIA"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886755
- Sponsor's protocol ID
- CSUB0069
- Status last verified
- Feb 2016
- First submitted
- 22 Jun 2013
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis
- ClinicalTrials.gov ID
- NCT01886755
- Acronym / sponsor ID
- CSUB0069
- Conditions
- Acute Gastroenteritis
- Keywords
- Acute gastroenteritis, Probiotics, Lactobacillus reuteri, Zinc supplementation, Infants, Age 6 months to 36 months
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Alexandra PapadopoulouUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An ORS with L. reuteri DSM 17938 and zinc is expected to reduce duration and severity of symptoms in infants and young children with acute gastroenteritis.
Detailed description
Oral rehydration solution is recommended for treatment and prevention of dehydration due to acute gastroenteritis in infants and children (WHO/UNICEF, 2004; ESPGHAN / ESPID Guidelines, 2008). Acute diarrhoea may lead to zinc depletion in infants, and zinc supplementation is recommended in infants and children with acute gastroenteritis living in developing countries. In developed countries however, the studies on the efficacy of zinc supplementation in children with acute gastroenteritis are few and conflicting.
Selected strains of probiotics, including L. reuteri ATCC 55730, have been shown in several studies to reduce the duration and the severity of diarrhoea in children with acute gastroenteritis and the effect is greater if the probiotics are given within 60 hours from the onset of symptoms. Lactobacillus reuteri (L. reuteri) has been shown to reduce the duration and severity of acute gastroenteritis in children aged 6-36 months. In these studies L. reuteri was reported to have clinical effect on diarrhoea of both bacterial and viral (rotavirus) origin. Furthermore, L. reuteri strain DSM 17938 has recently been shown to reduce the duration of watery diarrhoea by 1.2 days among 6-36 mo old Italian children with acute gastroenteritis treated in hospital.
The present study is a prospective, randomized, double blind, controlled study with parallel groups. The planned investigation is designed to compare the efficacy of an ORS with L. reuteri DSM 17938 and zinc to an ORS with similar osmolarity and content of salts but without L. reuteri DSM 17938 and zinc, on the duration and severity of acute gastroenteritis. 92 children aged 6-36 months seen at private pediatric clinics and/or at the emergency clinics of the Athens Childrens Hospital "AGIA SOPHIA", and treated either as outpatients or as inpatients will be recruited until the final sample size is reached. Assuming a difference of 30% between groups in the primary outcome of prevalence of diarrhoea on day 2, and estimating an attrition rate of approximately 15%, the final sample size will be 92 subjects, or 46 subjects in each arm.
Data collection points will be on day 7 at the outpatient clinic of the Division of Pediatric Gastroenterology \& Nutrition of the First Department of Paediatrics, Athens University Hospital.
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 |
|---|---|---|
| ORS with probiotic and zinc | Experimental | Dietary Supplement: ORS rehydration solutionORS with probiotic and zinc Oral rehydration solution with freeze-dried Lactobacillus reuteri DSM 17938 and zinc sulphate |
| Placebo Comparator | Placebo comparator | Dietary Supplement: placeboStandard oral rehydration solution |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6 - 36 months old children
- 3 or more watery or soft stools per day for the past 24-48 hours
- Clinically judged as having mild to moderate dehydration (Bailey scale scores 1 to 4)
- Available throughout the study period
- Re-examination on the 7th day from the enrolment
Key exclusion criteria (9 listed)
- Diarrhoea lasting more than 48 h
- Clinical signs of severe dehydration (Bailey scale scores = or > 5)
- Malnutrition as judged by a body weight/height ratio below the 5th percentile
- Clinical signs of a coexisting severe acute systemic illness (meningitis, sepsis, pneumonia)
- Immunodeficiency
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 |
|---|---|---|
| ORS rehydration solution | Dietary supplement | ORS with probiotic and zinc |
| placebo | Dietary supplement | Placebo Comparator |
Primary outcome
Resolution of diarrhoea.
Time frame: 48 hrs after start of treatment
1. Proportion of children without watery (3A ISS by Amsterdam infant stool scale ) or soft (3B ISS Amsterdam infant stool scale) stools on day 2 of treatment. Day 0 = day of enrolment and start of treatment, day 1 = first complete day of treatment 2. Time from start of treatment and until last watery or soft stool.
1 secondary outcome
Reduction of severity of diarrhoea
Time frame: 120 hrs from the start on treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
Alexandra Papadopoulou, Dr principal investigator
Athens Children's Hospital "AGIA SOPHIA"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORS rehydration solution in people with Acute Gastroenteritis, run by Alexandra Papadopoulou at 1 site in Greece.
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 7 inclusion and 9 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 23 Feb 2016. 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 Greece. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resolution of diarrhoea. (time frame: 48 hrs after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2016.