Infant Nutrition DisordersNCT04112056
Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose
A study testing Drink the study formula (NAN Comfort producted by Nestle Deutschland AG) in people with Infant Nutrition Disorders and Gastrointestinal Dysfunction, run by Peking University at 1 site in China.
Trial summary
The study is a before-after trial to evaluate whether the study formula containing moderately hydrolyzed protein and low lactose will be able to improve mild gastrointestinal disorders (MGDs) in infants. Read more about this study
- Who is it for?
- Ages 7 days to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition Disorders, Gastrointestinal Dysfunction
- What is being tested?
- Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2019to 15 May 2020
- 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 7 days to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Obtaining the informed consent of infants' parents or guardians
- Term infants (≥37 gestational weeks)
- Healthy infants aged 7-180 days
- Formula feeding or mixed feeding
- With mild gastrointestinal disorders
- Drinking the study formula more than half of the total diet daily
Who cannot join
- Adding new auxiliary food in the latest week
- Any kind of probiotics is being used
- Using drugs
- Using the formula being studied
- Having a history of milk protein allergies according to parents' reports
- Can not follow the research plans
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huantai Maternal and Child Health Care Hospital
Zibo, Shandong, 256499
Ying-chao Mu, BD, 13792199881, 1319094858@qq.com
About this study
Official title: Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose: A Before-after Trial
The study is a before-after trial to evaluate whether the study formula containing moderately hydrolyzed protein and low lactose will be able to improve mild gastrointestinal disorders (MGDs) in infants. The study plans to recruit 90 infants between 7 days and 6 months old in Huantai Maternal and Child Health Care Hospital in Shandong Province and intervene for 14 consecutive days. On Day 0 (the time of enrolling group, but the intervention which infants recruited are asked to drink study formula begins on Day 1), Day 7, Day 14, Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) is used to collect infants gastrointestinal comfort, related behaviors and other information.
Read the detailed description
Mild gastrointestinal disorders in infants belong to the category of functional gastrointestinal disorders. It refers that the infants fed with formula have mild digestive dysfunction that can not be explained by organic lesions or biochemical abnormalities, mainly including intestinal colic, spitting milk, diarrhea, constipation, etc. Mild gastrointestinal disorders are common in infants aged 0 to 1 year old. A study across 15 cities in China on the prevalence of common gastrointestinal disorders in infants shows that about 1/3 of the infants have one or more types of gastrointestinal disorders, among of which diarrhea and spitting milk are most common, and most of them occur within the age of 6 months. To solve this problem, a special kind of formulas for infants containing moderately hydrolyzed protein and low lactose has been developed, and our study formula is one of them. The study formula has been already marketed in China and passed the test hosted by the comprehensive testing center of the Chinese academy of inspection and quarantine, but whether it can significantly improve the mild gastrointestinal disorders in Chinese infants remains to be evaluated.
The purpose of the study is to evaluate whether the study formula containing moderately hydrolyzed protein and low lactose will be able to improve mild gastrointestinal disorders (MGDs) in infants. After informed consent, 90 infants between 7 days and 6 months old with mild gastrointestinal disorders are included and asked to drink the study formula for 14 consecutive days as intervention. On Day 0 (the time of enrolling group, but the intervention begins on Day 1), Day 7, Day 14, the information on gastrointestinal comfort and related behaviors is collected through the Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13). Information on feeding, family background, anthropometric measurements and defecation is also collected. The primary endpoint of this study is gastrointestinal comfort calculated by IGSQ-13. The secondary endpoints include crying frequency, spitting milk frequency, flatulence frequency, stool frequency and consistency score, formula acceptability and satisfaction, adverse event, etc.
- Being tested
- Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)
- Keywords
- Mild gastrointestinal disorders, Infant formula, Infant gastrointestinal symptoms questionnaire
- Medical subject headings
- Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)Dietary supplement
It is same as that stated in arm description.
| Study group | Role | What they receive |
|---|---|---|
| Study formula | Experimental | The infants recruited are provided with the study formula named NAN Comfort producted by Nestle Deutschland AG, Werk Biessenhofen containing moderately hydrolyzed protein and low lactose for free during study, and asked to drink the study formula more than half of the total diet daily. Receives: Dietary Supplement: Drink the study formula (NAN Comfort producted by Nestle Deutschland AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
Measured: On Day 0 (the time of enrolling group)
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
Measured: On Day 7
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
Measured: On Day 14
Secondary outcomes (6)
Crying frequency
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Measured: On Day 0, Day 7 and Day 14
Spitting milk frequency
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Measured: On Day 0, Day 7 and Day 14
Flatulence frequency
Collected by Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13)
Measured: On Day 0, Day 7 and Day 14
Stool frequency and consistency
Collecting infants stool photos
Measured: On Day 1, Day 2 and Day 3
Formula acceptability and satisfaction
Collected by a structured questionnaire，which is designed for this study specially, including 5 questions, and will be analyzed separately for each question (no total score used).
Measured: On Day 14
Adverse event frequency
Confirmed by doctor
Measured: Day1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start10 Oct 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion15 May 2020 (estimated)
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 Infant Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Peking 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Huantai Maternal and Child Health Care Hospital
- Responsible party
- Principal investigator, Jianmeng Liu, Peking University
- Investigators
- Jian-meng Liu, PhD, Study chair, Peking UniversityYing-chao Mu, BD, Study director, Huantai Maternal and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112056
- Sponsor's protocol ID
- PKUFM.191010
- Status last verified
- Mar 2020
- First submitted
- 26 Sep 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang Y, Zhou Y, Li H, Chen Y, Mu Y, Yuan A, Yang Y, Liu J. The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial. Nutrients. 2021 Sep 25;13(10):3371. doi: 10.3390/nu13103371.
PubMed 34684372
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Surveillance Study of an Infant Formula Containing Moderately Hydrolyzed Protein and Low Lactose: A Before-after Trial
- ClinicalTrials.gov ID
- NCT04112056
- Acronym / sponsor ID
- PKUFM.191010
- Keywords
- Mild gastrointestinal disorders, Infant formula, Infant gastrointestinal symptoms questionnaire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Huantai Maternal and Child Health Care Hospital
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 2 Oct 2019 (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.
The study is a before-after trial to evaluate whether the study formula containing moderately hydrolyzed protein and low lactose will be able to improve mild gastrointestinal disorders (MGDs) in infants. The study plans to recruit 90 infants between 7 days and 6 months old in Huantai Maternal and Child Health Care Hospital in Shandong Province and intervene for 14 consecutive days. On Day 0 (the time of enrolling group, but the intervention which infants recruited are asked to drink study formula begins on Day 1), Day 7, Day 14, Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) is used to collect infants gastrointestinal comfort, related behaviors and other information.
Detailed description
Mild gastrointestinal disorders in infants belong to the category of functional gastrointestinal disorders. It refers that the infants fed with formula have mild digestive dysfunction that can not be explained by organic lesions or biochemical abnormalities, mainly including intestinal colic, spitting milk, diarrhea, constipation, etc. Mild gastrointestinal disorders are common in infants aged 0 to 1 year old. A study across 15 cities in China on the prevalence of common gastrointestinal disorders in infants shows that about 1/3 of the infants have one or more types of gastrointestinal disorders, among of which diarrhea and spitting milk are most common, and most of them occur within the age of 6 months. To solve this problem, a special kind of formulas for infants containing moderately hydrolyzed protein and low lactose has been developed, and our study formula is one of them. The study formula has been already marketed in China and passed the test hosted by the comprehensive testing center of the Chinese academy of inspection and quarantine, but whether it can significantly improve the mild gastrointestinal disorders in Chinese infants remains to be evaluated.
The purpose of the study is to evaluate whether the study formula containing moderately hydrolyzed protein and low lactose will be able to improve mild gastrointestinal disorders (MGDs) in infants. After informed consent, 90 infants between 7 days and 6 months old with mild gastrointestinal disorders are included and asked to drink the study formula for 14 consecutive days as intervention. On Day 0 (the time of enrolling group, but the intervention begins on Day 1), Day 7, Day 14, the information on gastrointestinal comfort and related behaviors is collected through the Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13). Information on feeding, family background, anthropometric measurements and defecation is also collected. The primary endpoint of this study is gastrointestinal comfort calculated by IGSQ-13. The secondary endpoints include crying frequency, spitting milk frequency, flatulence frequency, stool frequency and consistency score, formula acceptability and satisfaction, adverse event, etc.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study formula | Experimental | Dietary Supplement: Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)The infants recruited are provided with the study formula named NAN Comfort producted by Nestle Deutschland AG, Werk Biessenhofen containing moderately hydrolyzed protein and low lactose for free during study, and asked to drink the study formula more than half of the total diet daily. |
Who may qualify
- Ages
- 7 days to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Obtaining the informed consent of infants' parents or guardians
- Term infants (≥37 gestational weeks)
- Healthy infants aged 7-180 days
- Formula feeding or mixed feeding
- With mild gastrointestinal disorders
Key exclusion criteria (6 listed)
- Adding new auxiliary food in the latest week
- Any kind of probiotics is being used
- Using drugs
- Using the formula being studied
- Having a history of milk protein allergies according to parents' reports
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 |
|---|---|---|
| Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)It is same as that stated in arm description. | Dietary supplement | Study formula |
Primary outcome
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
Time frame: On Day 0 (the time of enrolling group)
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
Time frame: On Day 7
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score
Time frame: On Day 14
The IGSQ-13 is a validated instrument (Riley, Trabulsi et al. 2015) consisting of 5 GI symptoms and GI-related behavioural domains. Parents (caregivers) are asked to recall specific symptoms experienced in the past week. Possible index scores range from 13 to 65; higher scores indicate higher GI burden, while lower scores indicate less GI burden.
6 secondary outcomes
Crying frequency
Time frame: On Day 0, Day 7 and Day 14
Spitting milk frequency
Time frame: On Day 0, Day 7 and Day 14
Flatulence frequency
Time frame: On Day 0, Day 7 and Day 14
Stool frequency and consistency
Time frame: On Day 1, Day 2 and Day 3
Formula acceptability and satisfaction
Time frame: On Day 14
Adverse event frequency
Time frame: Day1 to Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Derived from this study: PubMed 34684372Huang Y, Zhou Y, Li H, Chen Y, Mu Y, Yuan A, Yang Y, Liu J. The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial. Nutrients. 2021 Sep 25;13(10):3371. doi: 10.3390/nu13103371.
Related trials for Infant Nutrition Disorders
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
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.
Jian-meng Liu, PhD study chair
Peking University
Ying-chao Mu, BD study director
Huantai Maternal and Child Health Care Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drink the study formula (NAN Comfort producted by Nestle Deutschland AG) in people with Infant Nutrition Disorders and Gastrointestinal Dysfunction, run by Peking 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 6 inclusion and 6 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 2 Apr 2020. 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?
Contact Yu-bo Zhou, PhD (18810533987, zhouyubo@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Gastrointestinal Symptoms Questionnaire-13 (IGSQ-13) Index Score (time frame: On Day 0 (the time of enrolling group)). The study lists 3 primary outcomes in all. 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 NCT04112056, 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 2 Apr 2020.