Acute Watery DiarrhoeaPhase 2ZincNCT01140074
Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children
A Phase 2 study testing Zinc Sulfate in people with Acute Watery Diarrhoea, run by University Hospital No 1 Wroclaw at 2 sites in Poland.
Trial summary
Diarrheal disease is one of the major causes of morbidity and mortality in children under five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In children with severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Acute Watery Diarrhoea
- What is being tested?
- Zinc Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 2 sitesPoland
- Study dates
- Jul 2010to Jun 2012
- Phase
- Phase 2
- 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 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-36 months
- Acute diarrhea defined as 3 or more watery stools per day
- Informed consent (parents)
Who cannot join
- Severe dehydration (> 10%)
- Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
- Immune deficiency
- Chronic digestive tract disease (e.g. celiac diseases, food allergy)
- Antibiotic therapy
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Szpital im Sw Jadwigi w Trzebicy
Trzebnica, 55-100
Jerzy Pejcz, MD, ++48713120913
Jerzy Pejcz, MD
Klinika Pediatrii i Chorob Infekcyjnych Akademii Medycznej we Wroclawiu
Wroclaw, 50-345
Leszek Szenborn, Prof, ++48717703151, szenborn@zak.am.wroc.pl
Ernest P. Kuchar, MD, ++48717703156, kuchar@zak.am.wroc.pl
About this study
Official title: Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children
Diarrheal disease is one of the major causes of morbidity and mortality in children under five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In children with severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. Zinc supplementation may also helpful in diarrheal children without zinc deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe. Objective of our study is to assess whether zinc supplementation given with probiotics and ORS is effective in acute diarrhea in children in Poland.
Read the detailed description
A double-blind, placebo controlled trial
- We are going to enroll 256 patients (aged > 1 months to 36 months) with acute watery diarrhea defined as 3 d or more watery stools per day lasting not less than 1 day and not longer than 5 days.
Exclusion criteria:
severe dehydration (> 10%) Coexisting severe infection (E.g. Sepsis, pneumonia, meningitis) Immune deficiency Chronic digestive tract disease (e.g. celiac diseases, food allergy) Therapy with Antibiotics
Patients will be randomly assigned to 2 groups to receive: (a) zinc sulfate 10-20 mg/day for 10 days plus probiotics for 5 days (b) placebo for 10 days plus probiotics for 5 days. Patients will be observed in ambulatory or in the hospital (if necessary) and followed up for 15 days.
Randomization 1:1
- Conditions
- Acute Watery Diarrhoea
- Being tested
- Zinc Sulfate
- Keywords
- acute diarrhoea, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc SulfateDrug
Also called brand product is not available in Poland
Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Zinc sulfate | Experimental | Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics Receives: Drug: Zinc Sulfate |
| Placebo | Placebo comparator | Children will be given placebo plus probiotics Receives: Drug: Zinc Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period of diarrhea in hours
The primary endpoint of our study is the time of acute diarrhea
Measured: 15 days
Secondary outcomes (1)
number of stools in consequent days
The secondary end points will be number of stools per day, necessity of hospitalization or not, tolerability and adherence to the therapy
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Watery DiarrhoeaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital No 1 Wroclaw
- Sponsor type
- University, hospital or other
- Investigators
- Leszek Szenborn, Prof, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140074
- Sponsor's protocol ID
- KB-501/2009
- Acronym
- Zinc
- Status last verified
- Jun 2010
- First submitted
- 7 Jun 2010
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larson CP, Nasrin D, Saha A, Chowdhury MI, Qadri F. The added benefit of zinc supplementation after zinc treatment of acute childhood diarrhoea: a randomized, double-blind field trial. Trop Med Int Health. 2010 Jun;15(6):754-61. doi: 10.1111/j.1365-3156.2010.02525.x. Epub 2010 Mar 29.
PubMed 20374562Fajolu IB, Emokpae A, Oduwole AO, Silva BO, Abidoye RO, Renner JK. Zinc supplementation in children with acute diarrhoea. Nig Q J Hosp Med. 2008 Apr-Jun;18(2):101-3. doi: 10.4314/nqjhm.v18i2.44997.
PubMed 19068562Boran P, Tokuc G, Vagas E, Oktem S, Gokduman MK. Impact of zinc supplementation in children with acute diarrhoea in Turkey. Arch Dis Child. 2006 Apr;91(4):296-9. doi: 10.1136/adc.2005.079939. Epub 2005 Dec 14.
PubMed 16354711Roy SK, Tomkins AM, Akramuzzaman SM, Behrens RH, Haider R, Mahalanabis D, Fuchs G. Randomised controlled trial of zinc supplementation in malnourished Bangladeshi children with acute diarrhoea. Arch Dis Child. 1997 Sep;77(3):196-200. doi: 10.1136/adc.77.3.196.
PubMed 9370894
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children
- ClinicalTrials.gov ID
- NCT01140074
- Acronym / sponsor ID
- Zinc / KB-501/2009
- Conditions
- Acute Watery Diarrhoea
- Keywords
- acute diarrhoea, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- University Hospital No 1 WroclawUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 9 Jun 2010 (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.
Diarrheal disease is one of the major causes of morbidity and mortality in children under five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In children with severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. Zinc supplementation may also helpful in diarrheal children without zinc deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe. Objective of our study is to assess whether zinc supplementation given with probiotics and ORS is effective in acute diarrhea in children in Poland.
Detailed description
A double-blind, placebo controlled trial
- We are going to enroll 256 patients (aged > 1 months to 36 months) with acute watery diarrhea defined as 3 d or more watery stools per day lasting not less than 1 day and not longer than 5 days.
Exclusion criteria:
severe dehydration (> 10%) Coexisting severe infection (E.g. Sepsis, pneumonia, meningitis) Immune deficiency Chronic digestive tract disease (e.g. celiac diseases, food allergy) Therapy with Antibiotics
Patients will be randomly assigned to 2 groups to receive: (a) zinc sulfate 10-20 mg/day for 10 days plus probiotics for 5 days (b) placebo for 10 days plus probiotics for 5 days. Patients will be observed in ambulatory or in the hospital (if necessary) and followed up for 15 days.
Randomization 1:1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc sulfate | Experimental | Drug: Zinc SulfateChildren in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics |
| Placebo | Placebo comparator | Drug: Zinc SulfateChildren will be given placebo plus probiotics |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1-36 months
- Acute diarrhea defined as 3 or more watery stools per day
- Informed consent (parents)
Key exclusion criteria (5 listed)
- Severe dehydration (> 10%)
- Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
- Immune deficiency
- Chronic digestive tract disease (e.g. celiac diseases, food allergy)
- Antibiotic therapy
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 |
|---|---|---|
| Zinc SulfateAlso: brand product is not available in PolandZinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days | Drug | Placebo, Zinc sulfate |
Primary outcome
Period of diarrhea in hours
Time frame: 15 days
The primary endpoint of our study is the time of acute diarrhea
1 secondary outcome
number of stools in consequent days
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2010.
- Background: PubMed 20374562Larson CP, Nasrin D, Saha A, Chowdhury MI, Qadri F. The added benefit of zinc supplementation after zinc treatment of acute childhood diarrhoea: a randomized, double-blind field trial. Trop Med Int Health. 2010 Jun;15(6):754-61. doi: 10.1111/j.1365-3156.2010.02525.x. Epub 2010 Mar 29.
- Background: PubMed 19068562Fajolu IB, Emokpae A, Oduwole AO, Silva BO, Abidoye RO, Renner JK. Zinc supplementation in children with acute diarrhoea. Nig Q J Hosp Med. 2008 Apr-Jun;18(2):101-3. doi: 10.4314/nqjhm.v18i2.44997.
- Background: PubMed 16354711Boran P, Tokuc G, Vagas E, Oktem S, Gokduman MK. Impact of zinc supplementation in children with acute diarrhoea in Turkey. Arch Dis Child. 2006 Apr;91(4):296-9. doi: 10.1136/adc.2005.079939. Epub 2005 Dec 14.
- Results publication: PubMed 9370894Roy SK, Tomkins AM, Akramuzzaman SM, Behrens RH, Haider R, Mahalanabis D, Fuchs G. Randomised controlled trial of zinc supplementation in malnourished Bangladeshi children with acute diarrhoea. Arch Dis Child. 1997 Sep;77(3):196-200. doi: 10.1136/adc.77.3.196.
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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.
Leszek Szenborn, Prof principal investigator
Wroclaw Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc Sulfate in people with Acute Watery Diarrhoea, run by University Hospital No 1 Wroclaw at 2 sites 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leszek Szenborn, Prof (++48717703151, szenborn@zak.am.wroc.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period of diarrhea in hours (time frame: 15 days). 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 NCT01140074, 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 10 Jun 2010.