Nutrition of Ileostomy InfantsNCT04707443
Enteral Nutrition in Infants With Ileostomy
An observational study of Nutrition of Ileostomy Infants, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study is a prospective, single center, practical, and observational open clinical study. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Nutrition of Ileostomy Infants
- Type of treatment
- Pill or oral medicine
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2021to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants, undergo enterostomy for various reasons within the age range of 0-6 months
Who may be able to join
- After birth, infants aged 0-6 months (including neonates) undergo small bowel ostomy for various reasons.
Who cannot join
- Primary liver and kidney dysfunction, congenital multiple malformations and chromosomal abnormalities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Tian Qian, M.d, 02164931981, drqiantian@fudan.edu.cn
Yiyao Zhou, Bachelor, 02164931980, kerry_zyy@yahoo.com
About this study
Official title: Correlation Between Enteral Nutrition and Early Prognosis in Infants Aged Under 6 Months Following Enterostomy
This study is a prospective, single center, practical, and observational open clinical study.
Read the detailed description
Infant enterostomy is one of the emergency surgeries in pediatric gastroenterology. The most common underlying conditions during infancy include necrotizing enterocolitis, intestinal necrosis, intestinal perforation, and congenital gastrointestinal malformations. Necrotizing enterocolitis also serves as a major cause of short bowel syndrome in infants. Infants with small bowel stoma leading to short bowel syndrome face a higher incidence of complications compared to adults. Additionally, small intestinal stomy inevitably come with various complications such as infection, electrolyte imbalance, nutrient deficiencies, and malnutrition.
Currently, both domestic and international studies have shown that breast milk is the preferred choice for infant nutrition. The benefits of breastfeeding have been widely reported. For postoperative infants with digestive tract surgery, breast milk's immunoglobulins and prebiotics can help promote beneficial gut bacteria and bioactive proteins (such as lactoferrin, lysozyme, and lipoproteins), growth factors that facilitate intestinal adaptation and maturation processes while enhancing feeding tolerance and preventing infections or inflammatory disorders.
However, according to literature reports on clinical practice operations after digestive tract surgery even if early breastfeeding was initiated in 88% of cases; only 44% of infants were still being breastfed at discharge. This is due to feeding intolerance following breastfeeding which manifests as gastric retention, abdominal distension, diarrhea etc., not only delaying growth but also prolonging hospital stay while causing other adverse clinical outcomes. Some discharged infants who started breastfeeding experienced diarrhea and dehydration leading to readmission. Clinically speaking this issue has often been addressed by substituting feeds with enteral nutrition preparations (deep hydrolyzed formulas or free amino acid formulas).
The objective of this study is to assess the impact of enteral nutrition, which involves selecting appropriate preparations and human breast milk based on the child's intestinal tolerance, on growth and developmental outcomes in children following enterostomy. Additionally, we aim to investigate its effects on postoperative intestinal permeability, stoma output, gut microbiota and metabolites, sepsis incidence, colitis occurrence as well as bile stasis.
- Conditions
- Nutrition of Ileostomy Infants
- Keywords
- ileostomy, Human breast milk, Enteral nutrition, extensive hydrolyzed formula, amino acid formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| enteral nutrition | Infants, undergo enterostomy for various reasons within the age range of 0-6 months.The enteral nutrition can be administered orally or via enteral nutrition, including breast milk, preterm formula, infant formula, extensive hydrolyzed formula or amino acid formula et al .To observe and study the efficacy, safety and tolerance of enteral nutrition in infants after enterostomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-scores of body weight
The patient will be weighed in the recumbent position on an electronic infant scale. Z-scores for weight for age (WAZ) was obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 4 weeks after enteral feeding
Secondary outcomes (13)
Z-scores of body length
The patient's body length will be measured on the electronic infant scale. Z-scores for weight for age (WAZ) was obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 4 weeks day after enteral feeding
The change of ostomy volume
The amount of fistula form the ostomy bag will be recorded at the first day, the 14th day and the 28th day of the enteral nutrition.
Measured: From the the day starting the enteral nutrition to the fourth week.
Z-scores of head circumference
Z-scores were obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
Measured: 4 weeks day after enteral feeding
Cholestasis
The diagnostic criteria include the requirement of parenteral nutrition administration for a duration exceeding 2 weeks and an elevated direct bilirubin level > 34 mmol/L
Measured: 4 weeks day after enteral feeding
The incidence rate of septicemia
The impact of enteral nutrition (including enteral nutrition and breast milk) on the occurrence of septicemia in pediatric patients following enterostomy
Measured: Prior to complete enteral nutrition
The incidence rate of colitis
The impact of enteral nutrition (including enteral nutrition and breast milk) on the occurrence of colitis in pediatric patients following enterostomy
Measured: Prior to complete enteral nutrition
D-lactic acid
Effect of enteral nutrition's impact on postoperative D-lactic acid level
Measured: One month after surgery
D-lactic acid
Effect of enteral nutrition's impact on postoperative D-lactic acid level
Measured: Reaching full enteral feeding
Adiponectin
Effect of enteral nutrition's impact on postoperative Adiponectin level
Measured: One month after surgery
Adiponectin
Effect of enteral nutrition's impact on postoperative Adiponectin level
Measured: Reaching full enteral feeding
leptin
Effect of enteral nutrition's impact on postoperative leptin level
Measured: One month after surgery
leptin
Effect of enteral nutrition's impact on postoperative leptin level
Measured: Reaching full enteral feeding
Overall duration of parenteral nutrition
For patients who cannot obtain sufficient nutrition through enteral feeding for more than 5 days, consideration should be given to providing parenteral nutrition support
Measured: 4 weeks day after enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start8 Jul 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition of Ileostomy InfantsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Tian, Children's Hospital of Fudan University
- Investigators
- Tian Qian, M.D., Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707443
- Sponsor's protocol ID
- (2020)288
- Status last verified
- Mar 2026
- First submitted
- 31 Dec 2020
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Enteral Nutrition and Early Prognosis in Infants Aged Under 6 Months Following Enterostomy
- ClinicalTrials.gov ID
- NCT04707443
- Acronym / sponsor ID
- (2020)288
- Conditions
- Nutrition of Ileostomy Infants
- Keywords
- ileostomy, Human breast milk, Enteral nutrition, extensive hydrolyzed formula, amino acid formula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Jan 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 is a prospective, single center, practical, and observational open clinical study.
Detailed description
Infant enterostomy is one of the emergency surgeries in pediatric gastroenterology. The most common underlying conditions during infancy include necrotizing enterocolitis, intestinal necrosis, intestinal perforation, and congenital gastrointestinal malformations. Necrotizing enterocolitis also serves as a major cause of short bowel syndrome in infants. Infants with small bowel stoma leading to short bowel syndrome face a higher incidence of complications compared to adults. Additionally, small intestinal stomy inevitably come with various complications such as infection, electrolyte imbalance, nutrient deficiencies, and malnutrition.
Currently, both domestic and international studies have shown that breast milk is the preferred choice for infant nutrition. The benefits of breastfeeding have been widely reported. For postoperative infants with digestive tract surgery, breast milk's immunoglobulins and prebiotics can help promote beneficial gut bacteria and bioactive proteins (such as lactoferrin, lysozyme, and lipoproteins), growth factors that facilitate intestinal adaptation and maturation processes while enhancing feeding tolerance and preventing infections or inflammatory disorders.
However, according to literature reports on clinical practice operations after digestive tract surgery even if early breastfeeding was initiated in 88% of cases; only 44% of infants were still being breastfed at discharge. This is due to feeding intolerance following breastfeeding which manifests as gastric retention, abdominal distension, diarrhea etc., not only delaying growth but also prolonging hospital stay while causing other adverse clinical outcomes. Some discharged infants who started breastfeeding experienced diarrhea and dehydration leading to readmission. Clinically speaking this issue has often been addressed by substituting feeds with enteral nutrition preparations (deep hydrolyzed formulas or free amino acid formulas).
The objective of this study is to assess the impact of enteral nutrition, which involves selecting appropriate preparations and human breast milk based on the child's intestinal tolerance, on growth and developmental outcomes in children following enterostomy. Additionally, we aim to investigate its effects on postoperative intestinal permeability, stoma output, gut microbiota and metabolites, sepsis incidence, colitis occurrence as well as bile stasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enteral nutrition | – | –Infants, undergo enterostomy for various reasons within the age range of 0-6 months.The enteral nutrition can be administered orally or via enteral nutrition, including breast milk, preterm formula, infant formula, extensive hydrolyzed formula or amino acid formula et al .To observe and study the efficacy, safety and tolerance of enteral nutrition in infants after enterostomy. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants, undergo enterostomy for various reasons within the age range of 0-6 months
Key inclusion criteria (1 listed)
- After birth, infants aged 0-6 months (including neonates) undergo small bowel ostomy for various reasons.
Key exclusion criteria (1 listed)
- Primary liver and kidney dysfunction, congenital multiple malformations and chromosomal abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Z-scores of body weight
Time frame: 4 weeks after enteral feeding
The patient will be weighed in the recumbent position on an electronic infant scale. Z-scores for weight for age (WAZ) was obtained from the World Health Organization Anthro software and WHO Child Growth Standards.
13 secondary outcomes
Z-scores of body length
Time frame: 4 weeks day after enteral feeding
The change of ostomy volume
Time frame: From the the day starting the enteral nutrition to the fourth week.
Z-scores of head circumference
Time frame: 4 weeks day after enteral feeding
Cholestasis
Time frame: 4 weeks day after enteral feeding
The incidence rate of septicemia
Time frame: Prior to complete enteral nutrition
The incidence rate of colitis
Time frame: Prior to complete enteral nutrition
D-lactic acid
Time frame: One month after surgery
D-lactic acid
Time frame: Reaching full enteral feeding
Adiponectin
Time frame: One month after surgery
Adiponectin
Time frame: Reaching full enteral feeding
leptin
Time frame: One month after surgery
leptin
Time frame: Reaching full enteral feeding
Overall duration of parenteral nutrition
Time frame: 4 weeks day after enteral feeding
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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.
Tian Qian, M.D. study director
Children's Hospital of Fudan University
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 Nutrition of Ileostomy Infants, run by Children's Hospital of Fudan 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian Qian, M.D. (02164931981, drqiantian@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z-scores of body weight (time frame: 4 weeks after enteral feeding). 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 3 Apr 2026.