Film forming devices in the treatment of children with acute gastroenteritis receiving oral rehydration solution (ORS): the Tasectan Plus in Children Study
| ISRCTN | ISRCTN65893282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65893282 |
| EudraCT/CTIS number | 2014-001814-24 |
| Secondary identifying numbers | CNTPK0414 |
- Submission date
- 24/06/2015
- Registration date
- 28/08/2015
- Last edited
- 24/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
The aim of this study is to investigate whether Tasectan Plus is better than treating acute diarrhoea in children with acute gastroenteritis receiving oral rehydration solution (ORS) than when they are treated with ORS alone.
Who can participate?
Children between 3 months to 12 years with acute diarrhoea.
What does the study involve?
Participants are randomly assigned into one of two groups. Those in group 1 are given Tasectan Plus with oral rehydration salts for 5 days. Those in group 2 are given only the oral rehydration salts. The treatment used in the study was according to products’s leaflet. The parents/tutors are asked to present at doctor's office 2 days later (or earlier if necessary as a result of the worsening of symptoms). During this visit the physician reviews the diary regarding the symptoms and any reported side effects. Further follow-up visits occur 5 days after the start of treatment and then again after 10 days.
What are the possible benefits and risks of participating?
Treatment offered in this study has the potential to treat a childs acute diarrhoea. Information obtained from this study may also help the researchers to better treat children aged 3 months - 12 years with acute diarrhoea. The treatments are given to the children according to the approved leaflet of each product. If the child required medical treatment for physical injury or disease directly caused by the use of the medical device in this study they will be reimbursed the necessary expenses for medical treatment.
Where is the study run from?
A total of seven private GPs in Romania.
When is the study starting and how long is it expected to run for?
July 2014 to February 2015
Who is funding the study?
Novintethical Pharma SA (Switzerland)
Who is the main contact?
Mr Manolache Mihal
mihai.manolache@cebis-int.com
Contact information
Public
CEBIS International
222 Plevnei Street, 3rd Floor
Bucharest
060016
Romania
 ORCID ID |
0000-0002-1811-3965 |
|---|---|
| Phone | +40731834503 |
| mihai.manolache@cebis-int.com |
Study information
| Study design | Multicentre randomized open-label parallel controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A multicentre, randomized, open label, two parallel groups (ORS versus ORS + Tasectan Plus) of children aged 3 months to 12 years with acute gastroenteritis (acute infectious diarrhoea). |
| Study hypothesis | Is Tasectan Plus better in reducing the duration of acute infectious diarrhoea in children aged 3 months to 12 years with acute gastroenteritis receiving oral rehydration solution (ORS)? |
| Ethics approval(s) | Ethical Committee of Scientific Research, Targu Mures, Romania, 08/07/2014 |
| Condition | Acute gastroenteritis (acute infectious diarrhoea) |
| Intervention | The intervention used in the study were: Tasectan Plus - a Gelatine Xyloglucan CE mark Medical Device Plus ORS (Oral Rehidration Solution) versus ORS alone. Administration of the treatments was done according to products approved leaflets in each arm. The treatment duration was 5 days. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Occurence of AE |
| Secondary outcome measures | Reduction of stools During the study we had 3 visits: Baseline visit, Visit 1 (2 days after baseline), Visit 2 (5 days after baseline). A telephone follow-up visit was performed at 10 days after Visit 2. The method used to measure the outcomes were by using a daily diary which has captured all the necessary information to measure the outcomes. |
| Overall study start date | 15/07/2014 |
| Overall study end date | 15/02/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 36 |
| Participant inclusion criteria | 1. Children aged 3 months to 12 years with diagnosis of acute gastroenteritis (acute infectious diarrhoea); acute diarrhoea is defined as ‘three or more liquid stools (rated 6 or 7 on Bristol Stool Scale) a day for less than 72 hours’ 2. Patient with absent or mild-moderate dehydration which can be addressed through oral rehydration therapy (ORS) 3. Patient for whom oral rehydration therapy (ORS) and diet is considered the appropriate treatment by the treating physician 4. Patients for whom hospitalisation is not needed and can be treated in an out-patient setting 5. Patients for whom antibiotic therapy is considered not necessary by the treating physician 6. Informed consent signed by the legal representative of the child to participate in the clinical trial |
| Participant exclusion criteria | 1. Infantile colic 2. Diarrhoea consequently to milk/protein intolerance 3. Severe dehydration needing intravenous rehydration 4. Need for hospitalisation 5. Use of antibiotics before the screening visit or need of antibiotics based on the clinical judgement of treating physician 6. Use of antidiarrheal treatment (antimotility, antisecretory, or adsorbent agents) before the screening visit or need of antidiarrheal agents based on the clinical judgement of treating physician 7. Chronic or toxic diarrhoea 8. Impossibility to follow the patient for more than 12 hours |
| Recruitment start date | 15/08/2014 |
| Recruitment end date | 15/01/2015 |
Locations
Countries of recruitment
- Romania
Study participating centres
Romania
Romania
Romania
Romania
Romania
Romania
Romania
Sponsor information
Industry
Via Pian Scairolo, 11
Pambio-Noranco
Lugano
CH-6915
Switzerland
| Phone | +41 (0)91 234 15 72 |
|---|---|
| mihai.manolache@cebis-int.com | |
| Website | http://www.novintethical.com |
"ROR" |
https://ror.org/05ypvb778 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | At least one article will be prepared and published in a scientific journal in 2015. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No |
Editorial Notes
24/05/2016: Publication reference added.
