DiarrheaNCT05052489
Registry and Clinical Observation of Children With Diarrhoeal Disease
An observational study of Diarrhea, run by Zhejiang University at 1 site in China.
Trial summary
This Study based on the actual clinical diagnosis and treatment of data, evaluate the clinical characteristics of children with diarrhea Therapeutic effect and security, and establish the platform to childhood diarrhea registration, long-term accumulation of clinical data, develop the clinical characteristics and… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- registy
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2021to May 2022
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 1. Acute diarrhea: infectious, such as viral bacteria, and non-infectious, such as improper diet and climate factors 2. Persistent chronic diarrhea,including: Food allergy, food intolerance, indigestion,Inflammatory bowel disease (IBD),Diarrhoeal irritable bowel syndrome,Antibiotic associated diarrhea (AAD),chronic hepatitis associated diarrhea, metabolic diseases associated diarrhea (such as diabetes mellitus with diarrhea), pancreatic exocrine dysfunction (cystic fibrosis), etc.
Who may be able to join
- Under the age of 18
- Children diagnosed with diarrhea, including:
- Acute diarrhea: infectious, such as viral bacteria, and non-infectious, such as improper diet and climate factors
- Persistent chronic diarrhea:
- Including the following diseases:
- Food allergy, food intolerance, indigestion, etc.;
Show all 10Show fewer
- Inflammatory bowel disease (IBD);
- Diarrhoeal irritable bowel syndrome;
- Antibiotic associated diarrhea (AAD);
- Others: chronic hepatitis associated diarrhea, metabolic diseases associated diarrhea (such as diabetes mellitus with diarrhea), pancreatic exocrine dysfunction (cystic fibrosis), etc 3. Volunteered to participate in this study and signed the informed consent or the guardian signed the informed consent
Who cannot join
- Class A infectious diseases associated with diarrhoea (cholera, plague)
- Children with congenital heart disease, immune deficiency, malformation of digestive tract, or with severe dysfunction of heart, lung, liver and kidney。
- Children receiving long-term immunosuppressive therapy (except children with IBD)。
- Children with gastrointestinal surgery and tumor;
- In addition to the above, the researchers determined that there were other children who were not suitable to participate in the study。
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital Affiliated to Zhejiang University Medical College
Hangzhou, Zhejiang
Mizu Jiang
About this study
Official title: Establishment of a Prospective Cohort of Children With Diarrhoeal Disease Registry and Clinical Observation Study
This Study based on the actual clinical diagnosis and treatment of data, evaluate the clinical characteristics of children with diarrhea Therapeutic effect and security, and establish the platform to childhood diarrhea registration, long-term accumulation of clinical data, develop the clinical characteristics and therapeutic effect of childhood diarrhea, safety monitoring data, and provide reliable data support for the clinical application.
Read the detailed description
To evaluate the causes, clinical manifestations, treatment plans and clinical outcomes of diarrhoeal disease in children in a real diagnosis and treatment setting。 Evaluate the effect of different treatment schemes in actual clinical application,the clinical use of nutrition-supported zinc in oral rehydration fluids,the influencing factors of clinical efficacy, including the demographic characteristics and clinical characteristics of the children, as well as drug combination regimens, etc. To evaluate the clinical use of antibiotics,the clinical effects of different probiotics in the treatment of diarrhoeal disease in children,the effectiveness, safety and economy of the dose course of the clinical application of Clostridium butyricum bivariate living agents, the medical costs and resource consumption of treatment for diarrhoeal diseases in children.
- Conditions
- Diarrhea
- Being tested
- registy
- Keywords
- probiotics, children
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
registyOther
Children with diarrhea were registered in the hospital. Baseline information of the children was recorded and followed up to observe the distribution of disease types, clinical manifestations, treatment plans and clinical outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes of diarrhoeal disease in children
symptom remission rate of children with diarrhoea
Measured: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
Secondary outcomes (4)
Influencing factors of clinical outcomes
Measured: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
Direct medical costs
including drugs, laboratory tests, treatment, emergency care, and other (all-cause) medical expenses
Measured: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
effectiveness of combined clostridium butyricum and bifidobacterium powders
Change from baseline in stool consistency during the period of observation
Measured: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
safety evaluation
The proportion of Adverse events and serious adverse events
Measured: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMay 2022 (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.
- More trials run by Zhejiang 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mizu Jiang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052489
- Sponsor's protocol ID
- MJiang-001
- Status last verified
- Sep 2021
- First submitted
- 21 Jul 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Prospective Cohort of Children With Diarrhoeal Disease Registry and Clinical Observation Study
- ClinicalTrials.gov ID
- NCT05052489
- Acronym / sponsor ID
- MJiang-001
- Conditions
- Diarrhea
- Keywords
- probiotics, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 22 Sep 2021 (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.
This Study based on the actual clinical diagnosis and treatment of data, evaluate the clinical characteristics of children with diarrhea Therapeutic effect and security, and establish the platform to childhood diarrhea registration, long-term accumulation of clinical data, develop the clinical characteristics and therapeutic effect of childhood diarrhea, safety monitoring data, and provide reliable data support for the clinical application.
Detailed description
To evaluate the causes, clinical manifestations, treatment plans and clinical outcomes of diarrhoeal disease in children in a real diagnosis and treatment setting。 Evaluate the effect of different treatment schemes in actual clinical application,the clinical use of nutrition-supported zinc in oral rehydration fluids,the influencing factors of clinical efficacy, including the demographic characteristics and clinical characteristics of the children, as well as drug combination regimens, etc. To evaluate the clinical use of antibiotics,the clinical effects of different probiotics in the treatment of diarrhoeal disease in children,the effectiveness, safety and economy of the dose course of the clinical application of Clostridium butyricum bivariate living agents, the medical costs and resource consumption of treatment for diarrhoeal diseases in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 1. Acute diarrhea: infectious, such as viral bacteria, and non-infectious, such as improper diet and climate factors 2. Persistent chronic diarrhea,including: Food allergy, food intolerance, indigestion,Inflammatory bowel disease (IBD),Diarrhoeal irritable bowel syndrome,Antibiotic associated diarrhea (AAD),chronic hepatitis associated diarrhea, metabolic diseases associated diarrhea (such as diabetes mellitus with diarrhea), pancreatic exocrine dysfunction (cystic fibrosis), etc.
Key inclusion criteria (10 listed)
- Under the age of 18
- Food allergy, food intolerance, indigestion, etc.;
- Inflammatory bowel disease (IBD);
- Diarrhoeal irritable bowel syndrome;
- Antibiotic associated diarrhea (AAD);
Key exclusion criteria (5 listed)
- Class A infectious diseases associated with diarrhoea (cholera, plague)
- Children with congenital heart disease, immune deficiency, malformation of digestive tract, or with severe dysfunction of heart, lung, liver and kidney。
- Children receiving long-term immunosuppressive therapy (except children with IBD)。
- Children with gastrointestinal surgery and tumor;
- In addition to the above, the researchers determined that there were other children who were not suitable to participate in the study。
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 |
|---|---|---|
| registyChildren with diarrhea were registered in the hospital. Baseline information of the children was recorded and followed up to observe the distribution of disease types, clinical manifestations, treatment plans and clinical outcomes | Other | – |
Primary outcome
Clinical outcomes of diarrhoeal disease in children
Time frame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
symptom remission rate of children with diarrhoea
4 secondary outcomes
Influencing factors of clinical outcomes
Time frame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
Direct medical costs
Time frame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
effectiveness of combined clostridium butyricum and bifidobacterium powders
Time frame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
safety evaluation
Time frame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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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?
An observational study of Diarrhea, run by Zhejiang University at 1 site in China.
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 10 inclusion and 5 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 22 Sep 2021. 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 China. 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.
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?
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?
Clinical outcomes of diarrhoeal disease in children (time frame: acute diarrhea up to 14 days；persistent diarrhea and chronic diarrhea up to 28 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 22 Sep 2021.