Infant Formula IntoleranceNCT02363582
The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
A study testing formula in people with Infant Formula Intolerance, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora.The purpose of this… Read more about this study
- Who is it for?
- Ages 5 to 7 weeks
- Conditions the study is for
- Infant Formula Intolerance
- What is being tested?
- formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jul 2015
- 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 5 to 7 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- full-term with a birth weight ≥2,500 g
- be in good health
- without symptoms of diarrhea, and had not received antibiotics for at least 1 week before enrollment
- exclusively fed by breast milk or infant formula
Who cannot join
- preterm infant
- with known diseases or currently taking medication drugs
- mixed feeding
- with symptoms of diarrhea
- received antibiotics within 1 week
Trial locations and contacts
1 site in 1 country.
About this study
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora.The purpose of this study is to investigate the stool characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting infant formula supplemented with prebiotics and lactoferrin.
Read the detailed description
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora as well as the intestinal immune systems. The purpose of this study is to investigate the stool characteristics（including intestinal microbiota） acceptability, and gastrointestinal tolerance in infants fed a starting infant formula supplemented with prebiotics and lactoferrin, and compared these data with infants on exclusively breast feeding.
- Conditions
- Infant Formula Intolerance
- Being tested
- formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formulaOther
An infant formula contains prebiotics and lactoferrin
| Study group | Role | What they receive |
|---|---|---|
| Breast fed | No intervention | healthy term infants on exclusively breast feeding , enrollment age: 30-50days old |
| Formula fed | Experimental | healthy term infants on exclusively formula fed , enrollment age: 30-50days old Receives: Other: formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
growth
Head circumferences and weight gain
Measured: 6 weeks
Secondary outcomes (2)
Gastrointestinal tolerance and safety
daily records of vomiting and stool characteristics; records of infection episodes and other adverse effects
Measured: 6 weeks
intestinal microbiota
test the bacteria composition in baby stools by DNA sequencing technology
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Formula IntoleranceStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang WU, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiang Wu, MD, Principal investigator, Xin Hua Hospital of Zhejiang Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363582
- Sponsor's protocol ID
- SCMCIRB-K2013005
- Status last verified
- Apr 2016
- First submitted
- 31 Jan 2015
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT02363582
- Acronym / sponsor ID
- SCMCIRB-K2013005
- Conditions
- Infant Formula Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Feb 2015 (estimated)
- 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.
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora.The purpose of this study is to investigate the stool characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting infant formula supplemented with prebiotics and lactoferrin.
Detailed description
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora as well as the intestinal immune systems. The purpose of this study is to investigate the stool characteristics（including intestinal microbiota） acceptability, and gastrointestinal tolerance in infants fed a starting infant formula supplemented with prebiotics and lactoferrin, and compared these data with infants on exclusively breast feeding.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast fed | No intervention | –healthy term infants on exclusively breast feeding , enrollment age: 30-50days old |
| Formula fed | Experimental | Other: formulahealthy term infants on exclusively formula fed , enrollment age: 30-50days old |
Who may qualify
- Ages
- 5 to 7 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- full-term with a birth weight ≥2,500 g
- be in good health
- without symptoms of diarrhea, and had not received antibiotics for at least 1 week before enrollment
- exclusively fed by breast milk or infant formula
Key exclusion criteria (5 listed)
- preterm infant
- with known diseases or currently taking medication drugs
- mixed feeding
- with symptoms of diarrhea
- received antibiotics within 1 week
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 |
|---|---|---|
| formulaAn infant formula contains prebiotics and lactoferrin | Other | Formula fed |
Primary outcome
growth
Time frame: 6 weeks
Head circumferences and weight gain
2 secondary outcomes
Gastrointestinal tolerance and safety
Time frame: 6 weeks
intestinal microbiota
Time frame: 6 weeks
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 22 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Infant Formula Intolerance
Not yet recruiting
Partially Hydrolyzed Whey Protein Formula for Infants With Mild Allergy
Mild Allergic Symptoms in Infants, Infant Feeding Intolerance
Not yet recruitingObservational study
Nutritional Evaluation of Infants Receiving Amino Acid-Based Formula
Cow's Milk Protein Allergy Protein Intolerance Failure to Thrive
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.
Jiang Wu, MD principal investigator
Xin Hua Hospital of Zhejiang Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing formula in people with Infant Formula Intolerance, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 4 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 22 Apr 2016. 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?
growth (time frame: 6 weeks). 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 Apr 2016.