Infant DevelopmentNCT05695300
Gut Health,Feces Characteristics and Growth of Infants Fed With a New Infant Organic Formula
A study testing BLM ORGANIC GOLD+, BLM ORGANIC and Breast milk in people with Infant Development, run by Bellamy's Organic Pty Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula). 75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast… Read more about this study
- Who is it for?
- Ages 30 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- BLM ORGANIC GOLD+, BLM ORGANIC and Breast milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2023to 31 May 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 30 to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 30 days of age at randomization and enrollment, inclusive (day of birth is considered day 0)
- Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
- Singleton birth
- Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
- Birth weight of 2490g to 4200g
- Signed informed consent obtained for infant's and mother's participation in the study
Who cannot join
- History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
- Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
- Infants with a known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
- Weight at randomization is <90% of birth weight [(weight at Visit 1÷birth weight) x 100 <90%]
- Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)
- Known head/brain disease/injury such as microcephaly, macrocephaly or others.
- Enrollment in another interventional clinical research study while participating in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Controlled Study to Evaluate the Gut Health, Feces Characteristics and Growth of Healthy Term Infants Fed With a New Infant Organic Formula
The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula).
75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast milk for 3 months.
Researchers will compare the three groups to evaluate the gut health, feces characteristics and growth of infants by the end of the study.
Read the detailed description
This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Approximately 75 partipants of 30 days old will be enrolled from a study site, 50 of whom will be randomized 1:1 to receive an mask labelled investigational formula or a control formula for 3 months of feeding. The remaining approximately 25 partipants will be enrolled as a breastfeeding reference group. Parents will be instructed to exclusively feed the study formula (formula groups) or exclusively human milk (breastfeeding group) during the study. The study will consist of 4 study visits, on baseline day, and every 30 days. At each visit, all relevant clinical data of partipants will be captured and recorded into CTMS (Clinical Trial Management System). The data will be exported, analyzed and reported upon the study completion.
- Conditions
- Infant Development
- Being tested
- BLM ORGANIC GOLD+, BLM ORGANIC, Breast milk
- Keywords
- infant formula, gut health, feces
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLM ORGANIC GOLD+Dietary supplement
Participants in this arm need to be fed the assigned infant formula daily for three months, no other formula or breast milk
BLM ORGANICDietary supplement
Participants in this arm need to be fed the assigned infant formula daily for three months,no other formula or breast milk
Breast milkDietary supplement
Participants in this arm need to be fed with breast milk daily for three months, no infant formula
| Study group | Role | What they receive |
|---|---|---|
| BLM ORGANIC GOLD+ | Active comparator | BLM ORGANIC GOLD+ infant formula,800g/can Receives: Dietary Supplement: BLM ORGANIC GOLD+ |
| BLM ORGANIC | Placebo comparator | BLM ORGANIC infant formula,800g/can Receives: Dietary Supplement: BLM ORGANIC |
| Breast milk | Other | Mother's breast milk Receives: Dietary Supplement: Breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stool consistency, color and amount
Change in stool consistency, color and amount (by Amsterdam Infant Stool Scale, AISS, 2008) from baseline to 3 months
Measured: over 3 months
Secondary outcomes (5)
Change rate of baby length
Change rate in mm/day of baby length for each visit interval
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate of baby head circumference
Change rate in mm/day of baby head circumference for each visit interval
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate of baby weight
Change rate in gram/day of baby weight for each visit interval
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Average daily intake of formula
Average daily intake of formula in gram or ml for each visit interval
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Frequency of adverse events
Frequency of adverse events for each visit interval
Measured: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start3 Feb 2023
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Infant 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellamy's Organic Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoyang Sheng, MD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695300
- Sponsor's protocol ID
- 22-SM-10-BLM-001
- Status last verified
- Apr 2023
- First submitted
- 5 Jan 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holscher HD, Czerkies LA, Cekola P, Litov R, Benbow M, Santema S, Alexander DD, Perez V, Sun S, Saavedra JM, Tappenden KA. Bifidobacterium lactis Bb12 enhances intestinal antibody response in formula-fed infants: a randomized, double-blind, controlled trial. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):106S-17S. doi: 10.1177/0148607111430817.
PubMed 22237870Szajewska H, Chmielewska A. Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials. BMC Pediatr. 2013 Nov 12;13:185. doi: 10.1186/1471-2431-13-185.
PubMed 24215626Taipale TJ, Pienihakkinen K, Isolauri E, Jokela JT, Soderling EM. Bifidobacterium animalis subsp. lactis BB-12 in reducing the risk of infections in early childhood. Pediatr Res. 2016 Jan;79(1-1):65-9. doi: 10.1038/pr.2015.174. Epub 2015 Sep 15.
PubMed 26372517Larsen CN, Nielsen S, Kaestel P, Brockmann E, Bennedsen M, Christensen HR, Eskesen DC, Jacobsen BL, Michaelsen KF. Dose-response study of probiotic bacteria Bifidobacterium animalis subsp lactis BB-12 and Lactobacillus paracasei subsp paracasei CRL-341 in healthy young adults. Eur J Clin Nutr. 2006 Nov;60(11):1284-93. doi: 10.1038/sj.ejcn.1602450. Epub 2006 May 24.
PubMed 16721394Kabeerdoss J, Devi RS, Mary RR, Prabhavathi D, Vidya R, Mechenro J, Mahendri NV, Pugazhendhi S, Ramakrishna BS. Effect of yoghurt containing Bifidobacterium lactis Bb12(R) on faecal excretion of secretory immunoglobulin A and human beta-defensin 2 in healthy adult volunteers. Nutr J. 2011 Dec 23;10:138. doi: 10.1186/1475-2891-10-138.
PubMed 22196482Mohan R, Koebnick C, Schildt J, Mueller M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on body weight, fecal pH, acetate, lactate, calprotectin, and IgA in preterm infants. Pediatr Res. 2008 Oct;64(4):418-22. doi: 10.1203/PDR.0b013e318181b7fa.
PubMed 18552710
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Study to Evaluate the Gut Health, Feces Characteristics and Growth of Healthy Term Infants Fed With a New Infant Organic Formula
- ClinicalTrials.gov ID
- NCT05695300
- Acronym / sponsor ID
- 22-SM-10-BLM-001
- Conditions
- Infant Development
- Keywords
- infant formula, gut health, feces
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bellamy's Organic Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 25 Jan 2023 (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 goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula).
75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast milk for 3 months.
Researchers will compare the three groups to evaluate the gut health, feces characteristics and growth of infants by the end of the study.
Detailed description
This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Approximately 75 partipants of 30 days old will be enrolled from a study site, 50 of whom will be randomized 1:1 to receive an mask labelled investigational formula or a control formula for 3 months of feeding. The remaining approximately 25 partipants will be enrolled as a breastfeeding reference group. Parents will be instructed to exclusively feed the study formula (formula groups) or exclusively human milk (breastfeeding group) during the study. The study will consist of 4 study visits, on baseline day, and every 30 days. At each visit, all relevant clinical data of partipants will be captured and recorded into CTMS (Clinical Trial Management System). The data will be exported, analyzed and reported upon the study completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLM ORGANIC GOLD+ | Active comparator | Dietary Supplement: BLM ORGANIC GOLD+BLM ORGANIC GOLD+ infant formula,800g/can |
| BLM ORGANIC | Placebo comparator | Dietary Supplement: BLM ORGANICBLM ORGANIC infant formula,800g/can |
| Breast milk | Other | Dietary Supplement: Breast milkMother's breast milk |
Who may qualify
- Ages
- 30 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 30 days of age at randomization and enrollment, inclusive (day of birth is considered day 0)
- Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
- Singleton birth
- Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
- Birth weight of 2490g to 4200g
Key exclusion criteria (7 listed)
- History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
- Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
- Infants with a known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
- Weight at randomization is <90% of birth weight [(weight at Visit 1÷birth weight) x 100 <90%]
- Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)
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 |
|---|---|---|
| BLM ORGANIC GOLD+Participants in this arm need to be fed the assigned infant formula daily for three months, no other formula or breast milk | Dietary supplement | BLM ORGANIC GOLD+ |
| BLM ORGANICParticipants in this arm need to be fed the assigned infant formula daily for three months,no other formula or breast milk | Dietary supplement | BLM ORGANIC |
| Breast milkParticipants in this arm need to be fed with breast milk daily for three months, no infant formula | Dietary supplement | Breast milk |
Primary outcome
Change in stool consistency, color and amount
Time frame: over 3 months
Change in stool consistency, color and amount (by Amsterdam Infant Stool Scale, AISS, 2008) from baseline to 3 months
5 secondary outcomes
Change rate of baby length
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate of baby head circumference
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate of baby weight
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Average daily intake of formula
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Frequency of adverse events
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 22237870Holscher HD, Czerkies LA, Cekola P, Litov R, Benbow M, Santema S, Alexander DD, Perez V, Sun S, Saavedra JM, Tappenden KA. Bifidobacterium lactis Bb12 enhances intestinal antibody response in formula-fed infants: a randomized, double-blind, controlled trial. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):106S-17S. doi: 10.1177/0148607111430817.
- Background: PubMed 24215626Szajewska H, Chmielewska A. Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials. BMC Pediatr. 2013 Nov 12;13:185. doi: 10.1186/1471-2431-13-185.
- Background: PubMed 26372517Taipale TJ, Pienihakkinen K, Isolauri E, Jokela JT, Soderling EM. Bifidobacterium animalis subsp. lactis BB-12 in reducing the risk of infections in early childhood. Pediatr Res. 2016 Jan;79(1-1):65-9. doi: 10.1038/pr.2015.174. Epub 2015 Sep 15.
- Background: PubMed 16721394Larsen CN, Nielsen S, Kaestel P, Brockmann E, Bennedsen M, Christensen HR, Eskesen DC, Jacobsen BL, Michaelsen KF. Dose-response study of probiotic bacteria Bifidobacterium animalis subsp lactis BB-12 and Lactobacillus paracasei subsp paracasei CRL-341 in healthy young adults. Eur J Clin Nutr. 2006 Nov;60(11):1284-93. doi: 10.1038/sj.ejcn.1602450. Epub 2006 May 24.
- Background: PubMed 22196482Kabeerdoss J, Devi RS, Mary RR, Prabhavathi D, Vidya R, Mechenro J, Mahendri NV, Pugazhendhi S, Ramakrishna BS. Effect of yoghurt containing Bifidobacterium lactis Bb12(R) on faecal excretion of secretory immunoglobulin A and human beta-defensin 2 in healthy adult volunteers. Nutr J. 2011 Dec 23;10:138. doi: 10.1186/1475-2891-10-138.
- Background: PubMed 18552710Mohan R, Koebnick C, Schildt J, Mueller M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on body weight, fecal pH, acetate, lactate, calprotectin, and IgA in preterm infants. Pediatr Res. 2008 Oct;64(4):418-22. doi: 10.1203/PDR.0b013e318181b7fa.
- 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.
Xiaoyang Sheng, MD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BLM ORGANIC GOLD+, BLM ORGANIC and Breast milk in people with Infant Development, run by Bellamy's Organic Pty Ltd 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 7 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 13 Apr 2023. 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. Some participants in this study may receive a placebo. 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?
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?
Change in stool consistency, color and amount (time frame: over 3 months). 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 NCT05695300, which also lists 6 linked publications.
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 13 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.