Infant Formula IntoleranceNCT03178474
Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants
A study testing JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®, TOFER Infant formula,TOFER® and Breast milk in people with Infant Formula Intolerance and Well-being, run by Sun Yat-sen University at 3 sites in China.
Trial summary
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term Chinese infants. Read more about this study
- Who is it for?
- Ages 5 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Formula Intolerance, Well-being
- What is being tested?
- JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®, TOFER Infant formula,TOFER® and Breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2015to 30 Dec 2017
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants)
- Term infant of Chinese origin born at 37-42 gestation weeks
- Birth weight: 2500-4000g
- The infant is apparently healthy at birth and entry to study
- Apgar after 5 minutes >7
- age at the enrollment: 5-14 days
Who cannot join
- Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
- The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth
- The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth (not including photo treatment for infantile hepatitis)
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism
Trial locations and contacts
3 sites in 1 country.
China3 sites, 1 recruiting
- Terminated
Lankao Hospital
Kaifeng, Henan
- Terminated
Nanxiong Hospital
Shaoguan
- Recruiting
Shaoyang Center Hospital
Shaoyang, Hunan
Ding Ding
About this study
Official title: Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants: A Controlled Trial
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term Chinese infants.
Participants：189 healthy termed-infants with ages of 5-14 days at the enrollment.
Read more
Study Design: A multiple-center, quasi-randomized,open labeled, controlled trial. Random allocation between the two infant formula.
Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) JINLINGGUAN Formula Group：fed with JINLINGGUAN infant formula (PRO-KIDO™ I-PROTECH®, Phase I); (3) TOFER Formula Group: feeding TOFER infant formula (TOFER®, Phase I). Random allocation performed between the two formula groups.
Intervention Duration: 12 weeks.
Visits: 1 week(baseline), 7 and 13 weeks of age
Outcome measures: (1) General information, general health and wellbeing, regular body check;(2) Anthropometric parameters: body length, body weight, and head circumferences; (3) Stool characteristics (color , volume, stool consistency, and frequency;(4)Behavior and habits; (5) Gut microbiota; (6) Residual nutrients in feces (nitrogen,total fat, fatty acids, minerals); (7) adverse events and concomitant medications; (8) compliance. Slopes of changes from baseline to 6 and 12 weeks post intervention in anthropometric parameters, stool characteristic index, fecal residual nutrients, pattern score of gut microbiota, behavior and habit index were be calculated.
- Conditions
- Infant Formula Intolerance, Well-being
- Being tested
- JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®, TOFER Infant formula,TOFER®, Breast milk
- Keywords
- infant formula, Clinical trial, Chinese infant, body growth, gut microbiota, Stool characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®Other
JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®: a type of Phase I infant formula for 0-6 month infants, with a trademark of PRO-KIDO™ I-PROTECH®. The formula contains both OPO structured lipid and α+β patented protein (patent number: ZL200810241156.3).It was produced by Inner Mongolia Yili Industrial Group Co.Ltd.,China
TOFER Infant formula,TOFER®Other
TOFER Infant formula,TOFER®: a type of Phase I infant formula for 0-6 month infants, with a trademark of TOFER®. The formula was characterized by (1) Moderate digestible small-molecule protein; and (2) BID® complex probiotics. It was produced by Inner Mongolia Yili Industrial Group Co.Ltd.,China
Breast milkOther
Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
| Study group | Role | What they receive |
|---|---|---|
| Breast-Fed Group | Active comparator | The infants will be fed with human breast milk by their mother Receives: Other: Breast milk |
| TOFER Formula Group | Experimental | TOFER Infant formula,TOFER®: Infants will be fed by using TOFER® infant formula (Phase I baby formula) from baseline (about 5-14 days) to 13 weeks of age. Receives: Other: TOFER Infant formula,TOFER® |
| JINLINGGUAN Formula Group | Experimental | JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®: Infants will be fed by using JINLINGGUAN (PRO-KIDO™ I-PROTECH®) infant formula (Phase I baby formula) from baseline (about 5-14 days) to 13 weeks of age. Receives: Other: JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change Rate of Stool Characteristic Index from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in Stool Characteristic Index: calculated using stool color (using sample pictures), volume (small, normal or large using sample picture scale), stool consistency (runny, mushy, soft, formed or hard), and frequency
Measured: 0, 6, 12 weeks
Average Change Rate of Fecal Residual Nitrogen from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in Fecal Residual Nitrogen
Measured: 0, 6, 12 weeks
Average Change Rate of Fecal Residual Fat from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual total fat
Measured: 0, 6, 12 weeks
Average Change Rate of Fecal Residual Calcium from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual calcium
Measured: 0, 6, 12 weeks
Secondary outcomes (7)
Average Change Rate of an Index of General health and wellbeing from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in Index of General health and wellbeing, calculated from diseases (cold, diarrhea, bronchitis, pneumonia), doctor visits, gastro symptoms,etc.
Measured: 0, 6, 12 weeks
Average Change Rate of Behavior and Habit Score from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in Behavior and Habit Score assessed by infant behavior questionnaires
Measured: 0, 6, 12 weeks
Average Change Rate of body length from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in body length
Measured: 0, 6, 12 weeks
Average Change Rate of Body Weight from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in body weight
Measured: 0, 6, 12 weeks
Average Change Rate of Head Circumference from Baseline to 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in head circumference
Measured: 0, 6, 12 weeks
Average Change Rate of Gut Microbiota Pattern Score from Baseline at 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in gut microbiota pattern score from 16S RNA sequencing
Measured: 0, 6, 12 weeks
Average Change Rate of Pattern Score of Fecal Residual Fatty acids from Baseline at 6 and 12 weeks
Slope of change at 0, 6 and 12 weeks in the pattern score of fecal residual fatty acids
Measured: 0, 6, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Dec 2015
- Primary completion30 Jun 2017
- Study completion30 Dec 2017 (estimated)
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 Sun Yat-sen 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-ming Chen, Sun Yat-sen University
- Investigators
- Yuming Chen, Ph.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178474
- Sponsor's protocol ID
- Yili_trial01
- Status last verified
- Sep 2017
- First submitted
- 2 Jun 2017
- Last updated
- 18 Sep 2017
- 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 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants: A Controlled Trial
- ClinicalTrials.gov ID
- NCT03178474
- Acronym / sponsor ID
- Yili_trial01
- Conditions
- Infant Formula Intolerance, Well-being
- Keywords
- infant formula, Clinical trial, Chinese infant, body growth, gut microbiota, Stool characteristics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 7 Jun 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.
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term Chinese infants.
Participants：189 healthy termed-infants with ages of 5-14 days at the enrollment.
Study Design: A multiple-center, quasi-randomized,open labeled, controlled trial. Random allocation between the two infant formula.
Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) JINLINGGUAN Formula Group：fed with JINLINGGUAN infant formula (PRO-KIDO™ I-PROTECH®, Phase I); (3) TOFER Formula Group: feeding TOFER infant formula (TOFER®, Phase I). Random allocation performed between the two formula groups.
Intervention Duration: 12 weeks.
Visits: 1 week(baseline), 7 and 13 weeks of age
Outcome measures: (1) General information, general health and wellbeing, regular body check;(2) Anthropometric parameters: body length, body weight, and head circumferences; (3) Stool characteristics (color , volume, stool consistency, and frequency;(4)Behavior and habits; (5) Gut microbiota; (6) Residual nutrients in feces (nitrogen,total fat, fatty acids, minerals); (7) adverse events and concomitant medications; (8) compliance. Slopes of changes from baseline to 6 and 12 weeks post intervention in anthropometric parameters, stool characteristic index, fecal residual nutrients, pattern score of gut microbiota, behavior and habit index were be calculated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast-Fed Group | Active comparator | Other: Breast milkThe infants will be fed with human breast milk by their mother |
| TOFER Formula Group | Experimental | Other: TOFER Infant formula,TOFER®TOFER Infant formula,TOFER®: Infants will be fed by using TOFER® infant formula (Phase I baby formula) from baseline (about 5-14 days) to 13 weeks of age. |
| JINLINGGUAN Formula Group | Experimental | Other: JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®: Infants will be fed by using JINLINGGUAN (PRO-KIDO™ I-PROTECH®) infant formula (Phase I baby formula) from baseline (about 5-14 days) to 13 weeks of age. |
Who may qualify
- Ages
- 5 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants)
- Term infant of Chinese origin born at 37-42 gestation weeks
- Birth weight: 2500-4000g
- The infant is apparently healthy at birth and entry to study
- Apgar after 5 minutes >7
Key exclusion criteria (4 listed)
- Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
- The infant suffers from a major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth
- The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth (not including photo treatment for infantile hepatitis)
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism
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 |
|---|---|---|
| JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®: a type of Phase I infant formula for 0-6 month infants, with a trademark of PRO-KIDO™ I-PROTECH®. The formula contains both OPO structured lipid and α+β patented protein (patent number: ZL200810241156.3).It was produced by Inner Mongolia Yili Industrial Group Co.Ltd.,China | Other | JINLINGGUAN Formula Group |
| TOFER Infant formula,TOFER®TOFER Infant formula,TOFER®: a type of Phase I infant formula for 0-6 month infants, with a trademark of TOFER®. The formula was characterized by (1) Moderate digestible small-molecule protein; and (2) BID® complex probiotics. It was produced by Inner Mongolia Yili Industrial Group Co.Ltd.,China | Other | TOFER Formula Group |
| Breast milkBreast milk: Human breast milk, provided and fed by the corresponding infant's mother | Other | Breast-Fed Group |
Primary outcome
Average Change Rate of Stool Characteristic Index from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Slope of change at 0, 6 and 12 weeks in Stool Characteristic Index: calculated using stool color (using sample pictures), volume (small, normal or large using sample picture scale), stool consistency (runny, mushy, soft, formed or hard), and frequency
Average Change Rate of Fecal Residual Nitrogen from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Slope of change at 0, 6 and 12 weeks in Fecal Residual Nitrogen
Average Change Rate of Fecal Residual Fat from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual total fat
Average Change Rate of Fecal Residual Calcium from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Slope of change at 0, 6 and 12 weeks in fecal residual calcium
7 secondary outcomes
Average Change Rate of an Index of General health and wellbeing from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Average Change Rate of Behavior and Habit Score from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Average Change Rate of body length from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Average Change Rate of Body Weight from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Average Change Rate of Head Circumference from Baseline to 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Average Change Rate of Gut Microbiota Pattern Score from Baseline at 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Average Change Rate of Pattern Score of Fecal Residual Fatty acids from Baseline at 6 and 12 weeks
Time frame: 0, 6, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Yuming Chen, Ph.D. principal investigator
Sun Yat-sen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®, TOFER Infant formula,TOFER® and Breast milk in people with Infant Formula Intolerance and Well-being, run by Sun Yat-sen University at 3 sites 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 6 inclusion and 4 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 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Yuming Chen, Ph.D. (8613710230430, chenyum@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Change Rate of Stool Characteristic Index from Baseline to 6 and 12 weeks (time frame: 0, 6, 12 weeks). The study lists 4 primary outcomes in all. 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 18 Sep 2017.