Nutrition SupportingNCT04598841
Nutrition Support for Hirschsprung Disease
A study testing supplement nutritional supporting in people with Nutrition Supporting and Hirschsprung Disease, run by Tongji Hospital at 1 site in China.
Trial summary
A multi-center, prospective,randomized, non-blind, controlled study was conducted to investigate the effects of different pre-operative nutritional support modes on perioperative nutritional status, surgical treatment success rate, and rehabilitation process in children with Hirschsprung disease. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- Nutrition Supporting, Hirschsprung Disease, Infants
- What is being tested?
- supplement nutritional supporting
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Oct 2022
- 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 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 0-5 years.
- Clinical diagnosis with Hirschsprung's disease who requires surgery;
Who cannot join
- Complicated with severe complications such as enterocolitis associated with Hirschsprung disease;
- History of diseases associated with various organ systems that may be life-threatening;
- Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child;
- Patients who have participated in other clinical trials within the last 1 month;
- Any other conditions in which the investigator considers it inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease
A multi-center, prospective,randomized, non-blind, controlled study was conducted to investigate the effects of different pre-operative nutritional support modes on perioperative nutritional status, surgical treatment success rate, and rehabilitation process in children with Hirschsprung disease.
- Conditions
- Nutrition Supporting, Hirschsprung Disease, Infants, Prospective Study
- Being tested
- supplement nutritional supporting
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplement nutritional supportingDietary supplement
Special medical formula for the purpose of formula food
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Intravenous nutrition or oral high-calorie diet 7-10 days before surgery Receives: Dietary Supplement: supplement nutritional supporting |
| control group | No intervention | normal diet before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of postoperative HAEC
Incidence of postoperative HAEC
Measured: 3 months
Secondary outcomes (4)
Z score
weight/age
Measured: 3 months
LOS
length of postoperative stay
Measured: 1 months
reoperation
rate of reoperation
Measured: 3 months
readmission
rate of readmission
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jan 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 Nutrition SupportingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiexiong Feng, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598841
- Sponsor's protocol ID
- TJH-HSCRNS
- Status last verified
- Apr 2023
- First submitted
- 18 Oct 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang HY, Chen K, Zhang Y, Gao T, Huang Y, Ge L, Yuan Y, Zhang G, Yang H, Ren H, Zhan J, Xu W, Liu X, Zhu T, Feng J. Preoperative nutritional support in children with Hirschsprung disease: a prospective multicenter open-label randomized controlled trial. Nat Commun. 2025 Dec 19;16(1):11171. doi: 10.1038/s41467-025-66541-x.
PubMed 41419466
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease
- ClinicalTrials.gov ID
- NCT04598841
- Acronym / sponsor ID
- TJH-HSCRNS
- Conditions
- Nutrition Supporting, Hirschsprung Disease, Infants, Prospective Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 22 Oct 2020 (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 multi-center, prospective,randomized, non-blind, controlled study was conducted to investigate the effects of different pre-operative nutritional support modes on perioperative nutritional status, surgical treatment success rate, and rehabilitation process in children with Hirschsprung disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Dietary Supplement: supplement nutritional supportingIntravenous nutrition or oral high-calorie diet 7-10 days before surgery |
| control group | No intervention | –normal diet before surgery |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 0-5 years.
- Clinical diagnosis with Hirschsprung's disease who requires surgery;
Key exclusion criteria (5 listed)
- Complicated with severe complications such as enterocolitis associated with Hirschsprung disease;
- History of diseases associated with various organ systems that may be life-threatening;
- Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child;
- Patients who have participated in other clinical trials within the last 1 month;
- Any other conditions in which the investigator considers it inappropriate to participate in the trial.
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 |
|---|---|---|
| supplement nutritional supportingSpecial medical formula for the purpose of formula food | Dietary supplement | intervention group |
Primary outcome
rate of postoperative HAEC
Time frame: 3 months
Incidence of postoperative HAEC
4 secondary outcomes
Z score
Time frame: 3 months
LOS
Time frame: 1 months
reoperation
Time frame: 3 months
readmission
Time frame: 3 months
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 4 Apr 2023.
- Derived from this study: PubMed 41419466Zhang HY, Chen K, Zhang Y, Gao T, Huang Y, Ge L, Yuan Y, Zhang G, Yang H, Ren H, Zhan J, Xu W, Liu X, Zhu T, Feng J. Preoperative nutritional support in children with Hirschsprung disease: a prospective multicenter open-label randomized controlled trial. Nat Commun. 2025 Dec 19;16(1):11171. doi: 10.1038/s41467-025-66541-x.
Related trials for Nutrition Supporting
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Recruiting
Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
Cancer Survivorship
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
Not yet recruiting
Nutrition Intervention Optimization to Better Utilize Resources and Support Health
Diabete Type 2, Obesity & Overweight
Recruiting
PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes
Prediabetic State, Life Style
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 study testing supplement nutritional supporting in people with Nutrition Supporting and Hirschsprung Disease, run by Tongji Hospital 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 2 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: finished, as of the sponsor's last update on 4 Apr 2023. 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?
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?
rate of postoperative HAEC (time frame: 3 months). 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 NCT04598841, 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 4 Apr 2023.