Acute GastroenteritisPhase 1NCT02280759
Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.
A Phase 1 study testing Gelatin Tannate in people with Acute Gastroenteritis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- Gelatin Tannate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2014to 10 Jun 2017
- Phase
- Phase 1
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children < 5 years old
- diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
- inform consent sign
Who cannot join
- regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission
- underlying gastrointestinal tract disorder presenting with diarrhea
- breastfeeding >50%
- malnutrition (weight/high <3pc)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Paediatrics, The Medical University of Warsaw, Poland
Warsaw, 01-183
About this study
Official title: Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .
Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.
- Conditions
- Acute Gastroenteritis
- Being tested
- Gelatin Tannate, Placebo
- Keywords
- diarrhea, gelatin tannate, acute gastroenteritis
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin TannateDrug
PlaceboDrug
Placebo consists of an identical formulation, except active substance
| Study group | Role | What they receive |
|---|---|---|
| Gelatin Tannate | Active comparator | Gelatin Tannate:
4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years. Receives: Drug: Gelatin Tannate |
| Placebo | Placebo comparator | Placebo consists of an identical formulation, except active substance. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours
Measured: 7 days
Secondary outcomes (8)
Need of intravenous rehydration due to diarrhea
Measured: 7 days
Need of hospitalization in outpatients
Measured: 7 days
Vomiting
Measured: How many times for 7days
Weight gain
Measured: 7 days
Diarrhea recurrence
Measured: 7 days
Frequency of watery stools
Measured: 7 days
Adverse effects
Measured: 7 days
Severity of diarrhea due to modified Vesikari score
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startNov 2014
- Primary completion10 Jun 2017
- Study completion10 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute GastroenteritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanna Szajewska, Profesor, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280759
- Sponsor's protocol ID
- KB56/2014
- Status last verified
- Jul 2017
- First submitted
- 29 Oct 2014
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kolodziej M, Bebenek D, Konarska Z, Szajewska H. Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial. BMJ Open. 2018 May 24;8(5):e020205. doi: 10.1136/bmjopen-2017-020205.
PubMed 29794092Michalek D, Kolodziej M, Konarska Z, Szajewska H. Efficacy and safety of gelatine tannate for the treatment of acute gastroenteritis in children: protocol of a randomised controlled trial. BMJ Open. 2016 Feb 19;6(2):e010530. doi: 10.1136/bmjopen-2015-010530.
PubMed 26895988
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .
- ClinicalTrials.gov ID
- NCT02280759
- Acronym / sponsor ID
- KB56/2014
- Conditions
- Acute Gastroenteritis
- Keywords
- diarrhea, gelatin tannate, acute gastroenteritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 10 Jun 2017 (actual)
- Study completion
- 10 Jun 2017 (actual)
- First posted
- 31 Oct 2014 (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.
Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.
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 |
|---|---|---|
| Gelatin Tannate | Active comparator | Drug: Gelatin TannateGelatin Tannate: 4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo consists of an identical formulation, except active substance. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children < 5 years old
- diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
- inform consent sign
Key exclusion criteria (4 listed)
- regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission
- underlying gastrointestinal tract disorder presenting with diarrhea
- breastfeeding >50%
- malnutrition (weight/high <3pc)
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 |
|---|---|---|
| Gelatin Tannate | Drug | Gelatin Tannate |
| PlaceboPlacebo consists of an identical formulation, except active substance | Drug | Placebo |
Primary outcome
Duration of diarrhea
Time frame: 7 days
time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours
8 secondary outcomes
Need of intravenous rehydration due to diarrhea
Time frame: 7 days
Need of hospitalization in outpatients
Time frame: 7 days
Vomiting
Time frame: How many times for 7days
Weight gain
Time frame: 7 days
Diarrhea recurrence
Time frame: 7 days
Frequency of watery stools
Time frame: 7 days
Adverse effects
Time frame: 7 days
Severity of diarrhea due to modified Vesikari score
Time frame: 7 days
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 6 Jul 2017.
- Derived from this study: PubMed 29794092Kolodziej M, Bebenek D, Konarska Z, Szajewska H. Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial. BMJ Open. 2018 May 24;8(5):e020205. doi: 10.1136/bmjopen-2017-020205.
- Derived from this study: PubMed 26895988Michalek D, Kolodziej M, Konarska Z, Szajewska H. Efficacy and safety of gelatine tannate for the treatment of acute gastroenteritis in children: protocol of a randomised controlled trial. BMJ Open. 2016 Feb 19;6(2):e010530. doi: 10.1136/bmjopen-2015-010530.
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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.
Hanna Szajewska, Profesor 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 1 study testing Gelatin Tannate in people with Acute Gastroenteritis, 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 3 inclusion and 4 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 6 Jul 2017. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Duration of diarrhea (time frame: 7 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 NCT02280759, which also lists 2 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 6 Jul 2017.