DiarrheaPEDXIL01NCT03357237
EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
A study testing medical device in people with Diarrhea, run by Enriqueta Roamn at 1 site in Spain.
Trial summary
Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically translates into an acute episode of diarrhea and vomiting and is generally associated with an intestinal infectious disease. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- medical device
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to 30 Jul 2018
- Phase
- Interventional
- 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical of acute gastroenteritis: change in the consistency of stools to "loose" or liquid according to Bristol scale (6 or 7) or Amsterdam (infants) (A) and / or increase in the number of stools (greater or equal to 3 / day) with a duration of less than 72 h
- Age over 3 months and under 5 years
- Written informed consent according to ICH / GCP and local legislation, obtained before any study procedure of parents or guardians
Who cannot join
- Treatment with antibiotics, xyloglucan, gelatin tannate, racecadotril, smectite, probiotics or zinc (including oral rehydration solution containing zinc and / or probiotics) in the previous week
- Exclusive breastfeeding
- Chronic gastrointestinal disease (celiac disease, cystic fibrosis, inflammatory bowel disease, food allergy)
- Immunodeficiencies
- Malnutrition (weight / height / length less than P3 according to WHO standards)
- Severe dehydration
Show all 11Show fewer
- Impossibility of follow-up
- Known hypersensitivity to gelatin or xyloglucan
- Absence of informed consent
- Caregivers / parents who can not understand or comply with all the instructions and requirements of the study.
- If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could negatively influence
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
About this study
Official title: RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically translates into an acute episode of diarrhea and vomiting and is generally associated with an intestinal infectious disease. It is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. The important loss of liquids can lead to dehydration, acidosis and hydroelectrolitic alteration. Infants are more vulnerable to gastrointestinal infection and its consequences, dehydration and malnutrition.
There is no specific treatment, so it is exclusively symptomatic
Read more
A new type of products considered as mucoprotectors has been developed, such as gelatin tannate or xyloglucan, still with little data to establish recommendations on its use in the GEA. They would be able to reproduce in the intestine a muco-adhesive film or sheet protective It must be considered in this sense that mucus is the first barrier that protects the gastrointestinal tract against microorganisms or antigens and that bacterial invasion is related to the opening of narrow junctions.
Xyloglucan was approved in Europe as a medical device IIa to restore the physiological functions of the intestinal wall in the form of capsules for adults and envelopes for children.
Read the detailed description
A randomized, blinded study with a control group is proposed in this project to establish solidly the efficacy of xyloglucan in the treatment of acute gastroenteritis in children.
The main variable of evaluation will be the duration of diarrhea, defined as the time it takes to normalize the consistency of stools (according to the Bristol or Amsterdam scale) or their number.
Clinical trial in phase IV with medical product type IIa and CE marking, used in the same conditions in which it is marketed.
- Conditions
- Diarrhea
- Being tested
- medical device
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical deviceOther
patients will be assigned, following an external randomization, to two groups:
- Intervention or experimental group: treatment regimen with oral rehydration solution and xyloglucan
- Control or reference group: treatment regimen with oral rehydration solution and placebo
| Study group | Role | What they receive |
|---|---|---|
| XYLOGLUCAN | Experimental | treatment regimen with oral rehydration solution and xyloglucan Receives: Other: medical device |
| PLACEBO | Placebo comparator | rehydration solution and placebo. Receives: Other: medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of resolution of diarrhea
Number of days
Measured: 14 days
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 Dec 2017
- Primary completion30 Jan 2018
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Intervention or experimental group: treatment regimen with oral rehydration solution and xyloglucan * Control or reference group: treatment regimen with oral rehydration solution and placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enriqueta Roamn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enriqueta Roamn, Puerta de Hierro University Hospital
- Investigators
- Enriqueta Roman, PHD, Study director, Hospital Universitario Puerta de Hierro Majadahonda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357237
- Sponsor's protocol ID
- PEDXIL 01
- Acronym
- PEDXIL01
- Status last verified
- May 2018
- First submitted
- 24 Nov 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN
- ClinicalTrials.gov ID
- NCT03357237
- Acronym / sponsor ID
- PEDXIL01 / PEDXIL 01
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Enriqueta RoamnUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jul 2018 (estimated)
- 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.
Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically translates into an acute episode of diarrhea and vomiting and is generally associated with an intestinal infectious disease. It is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. The important loss of liquids can lead to dehydration, acidosis and hydroelectrolitic alteration. Infants are more vulnerable to gastrointestinal infection and its consequences, dehydration and malnutrition.
There is no specific treatment, so it is exclusively symptomatic
A new type of products considered as mucoprotectors has been developed, such as gelatin tannate or xyloglucan, still with little data to establish recommendations on its use in the GEA. They would be able to reproduce in the intestine a muco-adhesive film or sheet protective It must be considered in this sense that mucus is the first barrier that protects the gastrointestinal tract against microorganisms or antigens and that bacterial invasion is related to the opening of narrow junctions.
Xyloglucan was approved in Europe as a medical device IIa to restore the physiological functions of the intestinal wall in the form of capsules for adults and envelopes for children.
Detailed description
A randomized, blinded study with a control group is proposed in this project to establish solidly the efficacy of xyloglucan in the treatment of acute gastroenteritis in children.
The main variable of evaluation will be the duration of diarrhea, defined as the time it takes to normalize the consistency of stools (according to the Bristol or Amsterdam scale) or their number.
Clinical trial in phase IV with medical product type IIa and CE marking, used in the same conditions in which it is marketed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- * Intervention or experimental group: treatment regimen with oral rehydration solution and xyloglucan * Control or reference group: treatment regimen with oral rehydration solution and placebo.
| Arm | Type | Receives |
|---|---|---|
| XYLOGLUCAN | Experimental | Other: medical devicetreatment regimen with oral rehydration solution and xyloglucan |
| PLACEBO | Placebo comparator | Other: medical devicerehydration solution and placebo. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical of acute gastroenteritis: change in the consistency of stools to "loose" or liquid according to Bristol scale (6 or 7) or Amsterdam (infants) (A) and / or increase in the number of stools (greater or equal to 3 / day) with a duration of less than 72 h
- Age over 3 months and under 5 years
- Written informed consent according to ICH / GCP and local legislation, obtained before any study procedure of parents or guardians
Key exclusion criteria (11 listed)
- Treatment with antibiotics, xyloglucan, gelatin tannate, racecadotril, smectite, probiotics or zinc (including oral rehydration solution containing zinc and / or probiotics) in the previous week
- Exclusive breastfeeding
- Chronic gastrointestinal disease (celiac disease, cystic fibrosis, inflammatory bowel disease, food allergy)
- Immunodeficiencies
- Malnutrition (weight / height / length less than P3 according to WHO standards)
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 |
|---|---|---|
| medical devicepatients will be assigned, following an external randomization, to two groups: * Intervention or experimental group: treatment regimen with oral rehydration solution and xyloglucan * Control or reference group: treatment regimen with oral rehydration solution and placebo | Other | PLACEBO, XYLOGLUCAN |
Primary outcome
time of resolution of diarrhea
Time frame: 14 days
Number of days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Enriqueta Roman, PHD study director
Hospital Universitario Puerta de Hierro Majadahonda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical device in people with Diarrhea, run by Enriqueta Roamn at 1 site in Spain.
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 11 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 11 May 2018. 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 Spain. 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.
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 Maria Jose Garcia, MD (34911 91 60 00, mariajo_p_G@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of resolution of diarrhea (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2018.