Acute DiarrheaPhase 4NCT03356327
Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea
A Phase 4 study testing Actitan F and Standard Oral Rehydration in people with Acute Diarrhea, run by Federico II University at 1 site in Italy.
Trial summary
A pilot, randomized, case-controlled trial was conducted in 60 children affected by AG (< 7 days) with mild-moderate dehydration, according to WHO recommendations, from1 year to 17 years old. Read more about this study
- Who is it for?
- Ages 3 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Diarrhea
- What is being tested?
- Actitan F and Standard Oral Rehydration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2017to 1 Nov 2017
- Phase
- Phase 4
- 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 3 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients enrolled were children from 3 months to 12 years old, with a diagnosis of acute diarrhea appeared less than 7 days before the admission, capability to oral rehydration, mild to moderate dehydration.
Who cannot join
- Patients with diarrhea over 7 days, serious somatic pathology and severe dehydration were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea : A Pilot, Randomized, Control-case Study
A pilot, randomized, case-controlled trial was conducted in 60 children affected by AG (< 7 days) with mild-moderate dehydration, according to WHO recommendations, from1 year to 17 years old. Patients were divided into 2 Groups: Group 1 consisting of 30 children treated with Actitan F and standard oral rehydration (SOR); Group 2 consisting of 30 children who received only SOR. Both groups received treatment for seven days, respectively. Patients of Group 1 stopped for their own choice, SOR after the first 24 h and continued only with Actitan F.
Read the detailed description
The investigators included 60 children (mean age: 3.1yrs, range 0.3-12years) with a diagnosis of AG, referred between April and July 2017 to the Department of Translational Medicine, section of Pediatric, University of Naples Federico II.
Patients enrolled were children from 3 months to 12 years old, with a diagnosis of acute diarrhea appeared less than 7 days before the admission, capability to oral rehydration, mild to moderate dehydration. Patients with diarrhea over 7 days, serious somatic pathology and severe dehydration were excluded.
The study was approved by the Institutional Review Board of the University of Naples "Federico II" with the protocol number 25/17. At admission, written informed consent was obtained from participants' parents and from all patients older than 10 years. At first visit, a medical history was collected by one of the authors and all patients underwent clinical evaluation, including body weight and body temperature.
Frequency of bowel movements, stool consistency measured through the Bristol Stool Form Scale (BSFS) and other associated gastrointestinal symptoms, including nausea, vomiting, abdominal pain and rectal bleeding, were accurately recorded. The BSFS is the most commonly standardized instrument used to rate stool consistency in children. On admission, the degree of dehydration was clinically determined for each patient, based on WHO recommendations and data were recorded on a scale from 1 to 3 (1 for mild or <5%; 2 for moderate or 5% to 10%; 3 for severe or 10% and more).
Participants were randomly divided into two groups: Group 1 was treated with Actitan F and standard oral rehydration (SOR) and Group 2 was treated with SOR only ad libitum for 7 days. SOR is a reduced osmolarity oral solution (50/60 mmol/L Na), which is the first line therapy recommended by ESPGHAN guideline for Acute Diarrhea. Actitan F, instead, was orally administrated at dose of 1 sack every 4 hours, maximum 4 sacks/day for 7 days. Caregivers were instructed to administer the daily dose after mixing the contents of the sachet with a small amount of water. The study products used in this trial were donated by Aboca® Società Agricola SpA., Località Aboca, 20, 52037 Sansepolcro (AR) - Italy.
At home, all parents had to fulfill a daily diary to record number and consistency of stools, presence of fever, vomiting and children compliance with the therapy. During the final visit, scheduled after 7 days, the interim history was assessed, daily diaries were reviewed and discussed, and a physical evaluation was performed.
Outcomes
The primary outcome was the duration of diarrhea, defined as the number of stools after 24 hours of treatment or the time needed to normalize number and consistency of stools (compared with the period before the onset of diarrhea). Secondary outcomes were the evaluation of vomiting, body weight, possible need of hospitalization, compliance to therapy.
- Conditions
- Acute Diarrhea
- Being tested
- Actitan F, Standard Oral Rehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actitan FDrug
A molecolar complex of Tannins and Flavonoids used for acute diarrhea in children
Standard Oral RehydrationDrug
Standard oral rehydration as suggested by ESPGHAN guidelines
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 consisting of 30 children treated with Actitan F and standard oral rehydration (SOR) Receives: Drug: Actitan F; Drug: Standard Oral Rehydration |
| Group 2 | Active comparator | Group 2 consisting of 30 children who received only SOR. Receives: Drug: Standard Oral Rehydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of a medical device made of Actitan-F in the treatment of acute diarrhea, valuated on the basis of consistency of stools based on Bristol Stool Form
the effectiveness of a medical device made of Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile), in the treatment of acute gastroenteritis (AG) in children, valuated on the basis of stool consistency
Measured: 2 weeks
effectiveness of a medical device made of Actitan-F in the treatment of acute diarrhea, valuated on the basis of number of stools / day
he effectiveness of a medical device made of Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile), in the treatment of acute gastroenteritis (AG) in children, valuated on the basis of number of stools/day
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Apr 2017
- Primary completion31 Jul 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute DiarrheaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annamaria Staiano, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356327
- Sponsor's protocol ID
- 16/11/2017
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Russo M, Coppola V, Giannetti E, Buonavolonta R, Piscitelli A, Staiano A. Oral administration of tannins and flavonoids in children with acute diarrhea: a pilot, randomized, control-case study. Ital J Pediatr. 2018 Jun 4;44(1):64. doi: 10.1186/s13052-018-0497-6.
PubMed 29866147
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea : A Pilot, Randomized, Control-case Study
- ClinicalTrials.gov ID
- NCT03356327
- Acronym / sponsor ID
- 16/11/2017
- Conditions
- Acute Diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 29 Nov 2017 (actual)
- 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.
A pilot, randomized, case-controlled trial was conducted in 60 children affected by AG (< 7 days) with mild-moderate dehydration, according to WHO recommendations, from1 year to 17 years old. Patients were divided into 2 Groups: Group 1 consisting of 30 children treated with Actitan F and standard oral rehydration (SOR); Group 2 consisting of 30 children who received only SOR. Both groups received treatment for seven days, respectively. Patients of Group 1 stopped for their own choice, SOR after the first 24 h and continued only with Actitan F.
Detailed description
The investigators included 60 children (mean age: 3.1yrs, range 0.3-12years) with a diagnosis of AG, referred between April and July 2017 to the Department of Translational Medicine, section of Pediatric, University of Naples Federico II.
Patients enrolled were children from 3 months to 12 years old, with a diagnosis of acute diarrhea appeared less than 7 days before the admission, capability to oral rehydration, mild to moderate dehydration. Patients with diarrhea over 7 days, serious somatic pathology and severe dehydration were excluded.
The study was approved by the Institutional Review Board of the University of Naples "Federico II" with the protocol number 25/17. At admission, written informed consent was obtained from participants' parents and from all patients older than 10 years. At first visit, a medical history was collected by one of the authors and all patients underwent clinical evaluation, including body weight and body temperature.
Frequency of bowel movements, stool consistency measured through the Bristol Stool Form Scale (BSFS) and other associated gastrointestinal symptoms, including nausea, vomiting, abdominal pain and rectal bleeding, were accurately recorded. The BSFS is the most commonly standardized instrument used to rate stool consistency in children. On admission, the degree of dehydration was clinically determined for each patient, based on WHO recommendations and data were recorded on a scale from 1 to 3 (1 for mild or <5%; 2 for moderate or 5% to 10%; 3 for severe or 10% and more).
Participants were randomly divided into two groups: Group 1 was treated with Actitan F and standard oral rehydration (SOR) and Group 2 was treated with SOR only ad libitum for 7 days. SOR is a reduced osmolarity oral solution (50/60 mmol/L Na), which is the first line therapy recommended by ESPGHAN guideline for Acute Diarrhea. Actitan F, instead, was orally administrated at dose of 1 sack every 4 hours, maximum 4 sacks/day for 7 days. Caregivers were instructed to administer the daily dose after mixing the contents of the sachet with a small amount of water. The study products used in this trial were donated by Aboca® Società Agricola SpA., Località Aboca, 20, 52037 Sansepolcro (AR) - Italy.
At home, all parents had to fulfill a daily diary to record number and consistency of stools, presence of fever, vomiting and children compliance with the therapy. During the final visit, scheduled after 7 days, the interim history was assessed, daily diaries were reviewed and discussed, and a physical evaluation was performed.
Outcomes
The primary outcome was the duration of diarrhea, defined as the number of stools after 24 hours of treatment or the time needed to normalize number and consistency of stools (compared with the period before the onset of diarrhea). Secondary outcomes were the evaluation of vomiting, body weight, possible need of hospitalization, compliance to therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Actitan F, Drug: Standard Oral RehydrationGroup 1 consisting of 30 children treated with Actitan F and standard oral rehydration (SOR) |
| Group 2 | Active comparator | Drug: Standard Oral RehydrationGroup 2 consisting of 30 children who received only SOR. |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients enrolled were children from 3 months to 12 years old, with a diagnosis of acute diarrhea appeared less than 7 days before the admission, capability to oral rehydration, mild to moderate dehydration.
Key exclusion criteria (1 listed)
- Patients with diarrhea over 7 days, serious somatic pathology and severe dehydration were excluded.
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 |
|---|---|---|
| Actitan FA molecolar complex of Tannins and Flavonoids used for acute diarrhea in children | Drug | Group 1 |
| Standard Oral RehydrationStandard oral rehydration as suggested by ESPGHAN guidelines | Drug | Group 1, Group 2 |
Primary outcome
effectiveness of a medical device made of Actitan-F in the treatment of acute diarrhea, valuated on the basis of consistency of stools based on Bristol Stool Form
Time frame: 2 weeks
the effectiveness of a medical device made of Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile), in the treatment of acute gastroenteritis (AG) in children, valuated on the basis of stool consistency
effectiveness of a medical device made of Actitan-F in the treatment of acute diarrhea, valuated on the basis of number of stools / day
Time frame: 2 weeks
he effectiveness of a medical device made of Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile), in the treatment of acute gastroenteritis (AG) in children, valuated on the basis of number of stools/day
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 29 Nov 2017.
- Derived from this study: PubMed 29866147Russo M, Coppola V, Giannetti E, Buonavolonta R, Piscitelli A, Staiano A. Oral administration of tannins and flavonoids in children with acute diarrhea: a pilot, randomized, control-case study. Ital J Pediatr. 2018 Jun 4;44(1):64. doi: 10.1186/s13052-018-0497-6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Actitan F and Standard Oral Rehydration in people with Acute Diarrhea, run by Federico II University at 1 site in Italy.
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 1 inclusion and 1 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 29 Nov 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 Italy. 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?
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?
effectiveness of a medical device made of Actitan-F in the treatment of acute diarrhea, valuated on the basis of consistency of stools based on Bristol Stool Form (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 NCT03356327, which also lists 1 linked publication.
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 29 Nov 2017.