Infant Growth and DevelopmentNCT07886424
The Impact of Early-life Organic Feeding on Infants' Health: A Cluster Randomized Controlled Trial
A study testing Organic infant formula and organic complementary foods and Conventional infant formula and conventional complementary foods in people with Infant Growth and Development and Gut Microbiota, run by Tsinghua University at 3 sites in China.
Trial summary
This completed study compared early-life feeding with organic infant formula and organic complementary foods, conventional infant formula and conventional complementary foods, and breastfeeding with family-selected complementary foods. Read more about this study
- Who is it for?
- Ages 0 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Growth and Development, Gut Microbiota
- What is being tested?
- Organic infant formula and organic complementary foods and Conventional infant formula and conventional complementary foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesChina
- Study dates
- 22 Apr 2022to 24 Sep 2023
- 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 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infants born at 37 to 41 weeks of gestation.
- Birth weight of 2.5 to 4 kg.
- Infants from uncomplicated pregnancy and delivery, including cesarean delivery.
- Physically healthy infants with an Apgar score greater than 7 at 5 to 10 minutes after birth.
- For the formula-feeding intervention groups, exclusive or predominant formula feeding, with formula accounting for more than 70% of feeding occasions.
- For the breastfeeding reference group, mothers planned exclusive breastfeeding for the first 6 months.
- Parental or guardian informed consent.
Who cannot join
- Twins or other multiple births.
- Congenital disabilities.
- Known metabolic disorders or other major illnesses, including cardiac, respiratory, gastrointestinal, or other systemic disorders.
- Antibiotics or other gut microbiota regulators at enrollment.
- Lactose intolerance or cow's milk protein allergy.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chenzhou Maternal and Child Health Hospital (Main Campus)
Chenzhou, Hunan
Chenzhou Maternal and Child Health Hospital (Suxian Campus)
Chenzhou, Hunan
Guiyang Maternal and Child Health Hospital
Chenzhou, Hunan
About this study
This completed study compared early-life feeding with organic infant formula and organic complementary foods, conventional infant formula and conventional complementary foods, and breastfeeding with family-selected complementary foods. Infants were recruited in Chenzhou, Hunan, China, and followed through 8 months of age. The study examined physical growth, early development, gastrointestinal symptoms, stool characteristics, and gut microbiota. Measurements and questionnaires were collected at baseline and scheduled visits at 2, 4, 6, and 8 months of age. The aim was to assess whether organic feeding was associated with differences in infant health and gut microbiota compared with conventional feeding, with breastfeeding as a natural reference. Registration is being completed retrospectively after the study has finished.
Read the detailed description
Infants in the organic-feeding group received Bellamy's organic infant formula, with organic complementary foods introduced at approximately 5 to 6 months. Infants in the conventional-feeding group received conventional infant formula and conventional complementary foods. Breastfed infants formed a natural reference group; the choice and order of complementary foods were not assigned by the investigators. Follow-up included body weight, recumbent length, head circumference, Ages and Stages Questionnaires, gastrointestinal comfort and stool questionnaires, and fecal sampling for 16S rRNA microbiota analysis. Breast milk samples were collected in the breastfeeding group. The final report describes 32 breastfed, 27 organic-formula-fed, and 12 conventional-formula-fed infants recruited, with 30, 24, and 12, respectively, completing follow-up. Analyses included longitudinal models and per-protocol or sensitivity analyses. This description distinguishes recruitment counts from the numbers completing follow-up and does not report the planned sample size as actual enrollment.
- Conditions
- Infant Growth and Development, Gut Microbiota
- Being tested
- Organic infant formula and organic complementary foods, Conventional infant formula and conventional complementary foods
- Keywords
- Organic Infant Feeding, Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic infant formula and organic complementary foodsOther
Also called Bellamy's organic infant formula
Age-appropriate organic infant formula and organic complementary foods were provided according to the feeding schedule described for the Organic Feeding Group.
Conventional infant formula and conventional complementary foodsOther
Age-appropriate conventional infant formula and conventional complementary foods were provided according to the feeding schedule described for the Conventional Feeding Group.
| Study group | Role | What they receive |
|---|---|---|
| Organic Feeding Group | Experimental | Infants received Bellamy's Stage 1 organic formula from enrollment until 6 months of age, followed by Stage 2 organic formula. Organic complementary foods were introduced at approximately 5 to 6 months, starting with iron-rich purees and progressing to a diversified diet. By 9 months, at least eight complementary foods were recommended: two cereals, five vegetables or fruits, and one meat. Follow-up continued to 8 months of age. Receives: Other: Organic infant formula and organic complementary foods |
| Conventional Feeding Group | Active comparator | Infants received conventional Stage 1 infant formula from enrollment to 6 months, followed by conventional Stage 2 formula to 8 months. Conventional complementary foods were introduced at approximately 5 to 6 months, beginning with iron-rich purees and progressing to a diversified diet. Before 9 months, at least eight complementary foods were recommended, including two cereals, five vegetables or fruits, and one meat. Receives: Other: Conventional infant formula and conventional complementary foods |
| Breastfeeding Reference Group | No intervention | Infants were breastfed, with exclusive breastfeeding planned until 6 months of age. Complementary foods were introduced at approximately 5 to 6 months. Investigators did not assign the order or categories of complementary foods, and family feeding practices were documented. This group served as a natural reference, with follow-up through 8 months of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recumbent Length
Infant recumbent length in centimeters, measured during scheduled follow-up visits.
Measured: Baseline and at 2, 4, 6, and 8 months of age
Body Weight
Infant body weight in kilograms, measured during scheduled follow-up visits.
Measured: Baseline and at 2, 4, 6, and 8 months of age
Head Circumference
Infant head circumference in centimeters, measured during scheduled follow-up visits.
Measured: Baseline and at 2, 4, 6, and 8 months of age
Neuropsychological Development
Infant neuropsychological development assessed using the Ages and Stages Questionnaires (ASQ), covering communication, gross motor, fine motor, problem-solving, and personal-social domains.
Measured: At 6 and 8 months of age
Stool Form
Parent-reported infant stool characteristics assessed using the Bristol Stool Form Scale.
Measured: Baseline and at 2, 4, 6, and 8 months of age
Gut Microbiota Alpha Diversity
Within-sample diversity of the infant fecal microbiota assessed using 16S rRNA gene sequencing. The final report describes ACE, Chao, Shannon, and Simpson indices.
Measured: Baseline and at 2, 4, 6, and 8 months of age
Gut Microbiota Beta Diversity
Between-sample differences in infant fecal microbial community composition assessed using 16S rRNA gene sequencing. The final report describes weighted UniFrac distances.
Measured: Baseline and at 2, 4, 6, and 8 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start22 Apr 2022
- Primary completion24 Sep 2023
- Study completion24 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Growth and DevelopmentStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization was performed at the hospital-campus level using a sequence generated by an independent statistician with R. Allocation was concealed using sealed, opaque, sequentially numbered envelopes held by a third-party statistician. Three feeding groups were followed in parallel, including a breastfeeding natural-reference group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tsinghua University
- Sponsor type
- University, hospital or other
- Collaborators
- Mengniu Institute of Nutrition Science, Global R&D Innovation Center, Beijing
- Responsible party
- Principal investigator, Ai Zhao, Tsinghua University
- Investigators
- Ai Zhao, Principal investigator, Vanke School of Public Health, Tsinghua UniversityLiping He, Principal investigator, Vanke School of Public Health, Tsinghua University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886424
- Sponsor's protocol ID
- ChiECRT20210528
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data sharing is planned through Mendeley Data. The source registration states that data were deposited on March 9, 2026.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early-life Organic Feeding on Infants' Health: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07886424
- Acronym / sponsor ID
- ChiECRT20210528
- Conditions
- Infant Growth and Development, Gut Microbiota
- Keywords
- Organic Infant Feeding, Infant Formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Tsinghua UniversityUniversity, hospital or other
- Collaborators
- Mengniu Institute of Nutrition Science, Global R&D Innovation Center, Beijing
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 21 Oct 2026 (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 completed study compared early-life feeding with organic infant formula and organic complementary foods, conventional infant formula and conventional complementary foods, and breastfeeding with family-selected complementary foods. Infants were recruited in Chenzhou, Hunan, China, and followed through 8 months of age. The study examined physical growth, early development, gastrointestinal symptoms, stool characteristics, and gut microbiota. Measurements and questionnaires were collected at baseline and scheduled visits at 2, 4, 6, and 8 months of age. The aim was to assess whether organic feeding was associated with differences in infant health and gut microbiota compared with conventional feeding, with breastfeeding as a natural reference. Registration is being completed retrospectively after the study has finished.
Detailed description
Infants in the organic-feeding group received Bellamy's organic infant formula, with organic complementary foods introduced at approximately 5 to 6 months. Infants in the conventional-feeding group received conventional infant formula and conventional complementary foods. Breastfed infants formed a natural reference group; the choice and order of complementary foods were not assigned by the investigators. Follow-up included body weight, recumbent length, head circumference, Ages and Stages Questionnaires, gastrointestinal comfort and stool questionnaires, and fecal sampling for 16S rRNA microbiota analysis. Breast milk samples were collected in the breastfeeding group. The final report describes 32 breastfed, 27 organic-formula-fed, and 12 conventional-formula-fed infants recruited, with 30, 24, and 12, respectively, completing follow-up. Analyses included longitudinal models and per-protocol or sensitivity analyses. This description distinguishes recruitment counts from the numbers completing follow-up and does not report the planned sample size as actual enrollment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Cluster randomization was performed at the hospital-campus level using a sequence generated by an independent statistician with R. Allocation was concealed using sealed, opaque, sequentially numbered envelopes held by a third-party statistician. Three feeding groups were followed in parallel, including a breastfeeding natural-reference group.
| Arm | Type | Receives |
|---|---|---|
| Organic Feeding Group | Experimental | Other: Organic infant formula and organic complementary foodsInfants received Bellamy's Stage 1 organic formula from enrollment until 6 months of age, followed by Stage 2 organic formula. Organic complementary foods were introduced at approximately 5 to 6 months, starting with iron-rich purees and progressing to a diversified diet. By 9 months, at least eight complementary foods were recommended: two cereals, five vegetables or fruits, and one meat. Follow-up continued to 8 months of age. |
| Conventional Feeding Group | Active comparator | Other: Conventional infant formula and conventional complementary foodsInfants received conventional Stage 1 infant formula from enrollment to 6 months, followed by conventional Stage 2 formula to 8 months. Conventional complementary foods were introduced at approximately 5 to 6 months, beginning with iron-rich purees and progressing to a diversified diet. Before 9 months, at least eight complementary foods were recommended, including two cereals, five vegetables or fruits, and one meat. |
| Breastfeeding Reference Group | No intervention | –Infants were breastfed, with exclusive breastfeeding planned until 6 months of age. Complementary foods were introduced at approximately 5 to 6 months. Investigators did not assign the order or categories of complementary foods, and family feeding practices were documented. This group served as a natural reference, with follow-up through 8 months of age. |
Who may qualify
- Ages
- 0 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Term infants born at 37 to 41 weeks of gestation.
- Birth weight of 2.5 to 4 kg.
- Infants from uncomplicated pregnancy and delivery, including cesarean delivery.
- Physically healthy infants with an Apgar score greater than 7 at 5 to 10 minutes after birth.
- For the formula-feeding intervention groups, exclusive or predominant formula feeding, with formula accounting for more than 70% of feeding occasions.
Key exclusion criteria (5 listed)
- Twins or other multiple births.
- Congenital disabilities.
- Known metabolic disorders or other major illnesses, including cardiac, respiratory, gastrointestinal, or other systemic disorders.
- Antibiotics or other gut microbiota regulators at enrollment.
- Lactose intolerance or cow's milk protein allergy.
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 |
|---|---|---|
| Organic infant formula and organic complementary foodsAlso: Bellamy's organic infant formulaAge-appropriate organic infant formula and organic complementary foods were provided according to the feeding schedule described for the Organic Feeding Group. | Other | Organic Feeding Group |
| Conventional infant formula and conventional complementary foodsAge-appropriate conventional infant formula and conventional complementary foods were provided according to the feeding schedule described for the Conventional Feeding Group. | Other | Conventional Feeding Group |
Primary outcome
Recumbent Length
Time frame: Baseline and at 2, 4, 6, and 8 months of age
Infant recumbent length in centimeters, measured during scheduled follow-up visits.
Body Weight
Time frame: Baseline and at 2, 4, 6, and 8 months of age
Infant body weight in kilograms, measured during scheduled follow-up visits.
Head Circumference
Time frame: Baseline and at 2, 4, 6, and 8 months of age
Infant head circumference in centimeters, measured during scheduled follow-up visits.
Neuropsychological Development
Time frame: At 6 and 8 months of age
Infant neuropsychological development assessed using the Ages and Stages Questionnaires (ASQ), covering communication, gross motor, fine motor, problem-solving, and personal-social domains.
Stool Form
Time frame: Baseline and at 2, 4, 6, and 8 months of age
Parent-reported infant stool characteristics assessed using the Bristol Stool Form Scale.
Gut Microbiota Alpha Diversity
Time frame: Baseline and at 2, 4, 6, and 8 months of age
Within-sample diversity of the infant fecal microbiota assessed using 16S rRNA gene sequencing. The final report describes ACE, Chao, Shannon, and Simpson indices.
Gut Microbiota Beta Diversity
Time frame: Baseline and at 2, 4, 6, and 8 months of age
Between-sample differences in infant fecal microbial community composition assessed using 16S rRNA gene sequencing. The final report describes weighted UniFrac distances.
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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data sharing is planned through Mendeley Data. The source registration states that data were deposited on March 9, 2026.
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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.
Ai Zhao principal investigator
Vanke School of Public Health, Tsinghua University
Liping He principal investigator
Vanke School of Public Health, Tsinghua 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 Organic infant formula and organic complementary foods and Conventional infant formula and conventional complementary foods in people with Infant Growth and Development and Gut Microbiota, run by Tsinghua 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 7 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 21 Oct 2026. 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?
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?
Recumbent Length (time frame: Baseline and at 2, 4, 6, and 8 months of age). The study lists 7 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 21 Oct 2026.