Trial to evaluate the efficacy and safety of a combination of xyloglucan and gelose associated to oral rehydration salts for the treatment of acute diarrhea in children
| ISRCTN | ISRCTN61965252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61965252 |
| Secondary identifying numbers | IDCEB04-10 |
- Submission date
- 15/04/2020
- Registration date
- 24/04/2020
- Last edited
- 12/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Acute diarrhea, with or without vomiting, is a frequent problem in childhood. It is the second leading cause of death (after pneumonia), especially in children aged <3 years, and mortality is most frequent in low-income regions. Acute diarrhea is associated to high incidence of dehydration in infants. Other direct consequences of diarrhea in children include growth faltering, malnutrition, and impaired cognitive development in resource-limited countries. Oral rehydration and usage of oral rehydration salts (ORS) is the first-line treatment for all the children with acute diarrhea.
A new class of products, defined as “mucosal protectors” has been developed for use in gastroenteric diseases. These products form a bioprotective film on the intestinal mucosa, improving the resistance of the mucosa to pathologic aggression and helping to restore normal function. Among these film-forming products, Xyloglucan ( extracted from the seeds of the tamarind tree) is currently being studied and used for gastroenteric disorders.
This is a clinical trial to evaluate efficacy and safety of a combination of Xyloglucan and Gelose associated to Oral Rehydration Salts (ORS) for treatment of acute diarrhea in children.
The product works by forming a film which protects the intestinal mucosa, reducing the frequency and duration of diarrhoea episodes.
The primary objective of the study is to assess the efficacy of the product and the secondary objective is to assess safety.
Who can participate?
Children aged between three months and 14 years, suffering from acute gastroenteritis.
What does the study involve?
The study will include 120 subjects split into two groups: 60 subjects will receive the active product (xyloglucan and gelose+ORS) and the other 60 subjects will receive a product with no active ingredients (Placebo) + ORS. Neither subjects nor doctors will not know who receives the active product or the Placebo in order to avoid bias. The products will be administered to the subjects who meet the eligibility criteria and gave their informed consent to participate in the study. The treatments will be administrated by oral route. The treatment duration will be 5 days, and the total period of the study will be 7 days (including a follow-up visit at day 7).
What are the possible benefits and risks of participating?
The tested product could help reduce the symptoms of acute diarrhea and duration of diarrhea (by normalization of stool number and consistency). The risk of participating in the study is considered minimal to none as the procedures pose no harm to the subjects. The tested product is a medical device which has as main ingredients xyloglucan and gelose for which there are no known risks associated with their administration.
Where is the study run from?
CEBIS International (Romania)
When is the study starting and how long is it expected to run for?
August 2019 to November 2019
Who is funding the study?
NOVENTURE S.L. (Spain)
Who is the main contact?
Alina Maria Lordache, alina.iordache@cebis-int.com
Contact information
Scientific
CEBIS Int.
Theodor Pallady Boulevard, 47
Helios Business Center Buliding, B entrance, Third floor
District 3
Bucharest
032258
Romania
 ORCID ID |
0000-0002-5931-0463 |
|---|---|
| Phone | +40 737640721 |
| alina.iordache@cebis-int.com |
Study information
| Study design | Interventional double blind placebo controlled multicentre randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A randomized, double-blind, controlled trial to evaluate the efficacy and safety of a combination of xyloglucan and gelose associated to oral rehydration salts for the treatment of acute diarrhea in children (iDEA STUDY) |
| Study acronym | iDEA STUDY |
| Study hypothesis | A combination of Xyloglucan + gelose (Agar-agar) could help in the treatment of acute diarrhea in children in terms of reduction of the symptoms by restoring the physiological functions of the intestinal wall. This combination acts by forming a film which protects the intestinal mucosa, reducing the frequency and duration of diarrhoea episodes. |
| Ethics approval(s) | Approved 02/07/2019, National Committee for Bioethics of Medicinal Products and Medical Devices (19-21 Stefan Cel Mare Street, District 2, Bucharest, Romania, 020125; +40 212102880; comisie@bioetica-medicala.ro), ref: 1DM/02.07.2019 |
| Condition | Acute diarrhea |
| Intervention | The investigators will enroll in this study 120 subjects accordingly to the inclusion and exclusion criteria. The patient will be assigned to the experimental group(A) or control group(B) by using a computer-generated randomization sequence using a 1:1 ratio. Group A will receive Xyloglucan + gelose (Agar-agar) + Oral Rehydration Salts and Group B will receive Placebo + Oral Rehydration Salts. The products will be administered by oral route: children <3 years old: one sachet every 8 hours for 5 consecutive days, and children >3 years old: two sachets every 8 hours for 5 consecutive days |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Xyloglucan + gelose (Agar-agar) |
| Primary outcome measure | Duration of diarrhea, defined as the time until the normalization of stool consistency according to the Bristol stool form(BSF) scale (in BSF scale, numbers 2, 3, 4 and 5) or the time until the normalization of the number of stools (compared with the period before the onset of diarrhea) and the presence of normal stools for 48 h. Stool number and type evaluation will be done in each of the 5 days using the BSF scale. |
| Secondary outcome measures | 1. Symptoms evaluation: vomiting, no. of stools, type of stools, flatulence, presence of blood in stool, apathy) and monitoring of adverse events and concomitant medication measured by the experimenter on each of the 5 days and at day 7 2. Morphological parameters (height, weight, abdominal girth) and Hemodynamic parameters (blood pressure [SBP, DBP]; pulse, temperature; respiration) measured at day 1, 5 and 7 3. Laboratory Investigations (urine summary, CBC, C-reactive protein, transaminases, glucose, coprocitogram) measured at day 1 and 5 |
| Overall study start date | 01/03/2018 |
| Overall study end date | 29/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 100 |
| Participant inclusion criteria | 1. Acute gastroenteritis defined as a change in stool consistency according to the Bristol Stool Form (BSF) scale and/or an increase in the frequency of evacuations (typically ≥3 in 24 h) lasting more than 1 day and no longer than 3 days 2. Age group of children between ≥ 3 months and ≤ 14 years 3. A caregiver must provide written informed consent |
| Participant exclusion criteria | 1. Use of antibiotics, gelatine tannate, diosmectite, other probiotics, racecadotril, or zinc (including zinc containing ORS) within a week prior to enrolment 2. Exclusive breast feeding 3. Chronic diarrheal gastrointestinal disease (eg. inflammatory bowel diseases, cystic fibrosis, coeliac disease, food allergy) 4. Immunodeficiencies 5. Malnutrition (weight/height/length under 3rd percentile) (WHO Child Growth Standards will be used) 6. If needed, discontinuation or modification of the treatment may be considered at the discretion of the physician |
| Recruitment start date | 08/08/2019 |
| Recruitment end date | 22/11/2019 |
Locations
Countries of recruitment
- Romania
Study participating centres
Bucharest
030303
Romania
Iasi
700116
Romania
Timisoara
300011
Romania
Constanta
900178
Romania
Timisoara
300310
Romania
Bucharest
021105
Romania
Sponsor information
Other
Calle Consell de Cent 333
Barcelona
08007
Spain
| Phone | +34 932052718 |
|---|---|
| info@noventure.com | |
| Website | https://noventure.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | No plans for publication at this moment. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2021 | 12/05/2021 | Yes | No |
Editorial Notes
12/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
23/04/2020: Trial’s existence confirmed by National Committee for Bioethics of Medicinal Products and Medical Devices.
