Probiotic SupplementNCT04765852
Growth, Safety and Efficacy of a Probiotic Supplement
A study testing High dose probiotic supplement and Low dose probiotic supplement in people with Probiotic Supplement, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial summary
The primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of intervention Read more about this study
- Who is it for?
- Ages 14 to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Probiotic Supplement
- What is being tested?
- High dose probiotic supplement and Low dose probiotic supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 sitePhilippines
- Study dates
- 26 Feb 2021to 12 Oct 2021
- 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 14 to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study.
- Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
- Infants whose parent(s)/LAR have access to a working freezer.
- Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:
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- Healthy term (37-42 weeks of gestation) infant at birth.
- At enrolment visit, post-natal age 14-21 days (date of birth = day 0)
- Birth weight ≥ 2500g and ≤ 4500g.
- Breastfed and/or formula-fed infants (including exclusively and mixed fed breast- and formula-fed infants) whose parent(s)/LAR intent not to change the feeding regimen until the study end at 8 weeks of intervention.
- Formula-fed infants and their parent(s)/LAR must have independently elected, before enrolment not to breastfeed and their infant must tolerate a standard cow's milk infant formula not containing any probiotics at time of enrolment.
Who cannot join
- Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol.
- Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment.
- Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
- Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
- History of admission to the Neonatal Intensive Care Unit (NICU), except for admission for jaundice phototherapy.
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- Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study.
- Infants who are presently receiving or have received prior to enrollment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
- Currently participating or having participated in another clinical trial since birth.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Asian Foundation for Tropical Medicine, Inc.
City of Muntinlupa, 1781
About this study
Official title: Growth, Safety and Efficacy of a Probiotic Supplement: a Double-blind, Randomized, Placebo-controlled Trial
The primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of intervention
Read the detailed description
This is a randomized, placebo-controlled, double-blind study of healthy term infants, consisting of three randomized arms: placebo control group, high dose experimental group, and low dose experimental group. The study population, approximately 228, are infants 14 - 21 days of age who are formula-fed and/or breastfed who is aligned with the intended target population for a probiotic supplement. Placebo and probiotic supplements will be mixed with formula or breastmilk and fed orally using a feeding cup or syringe. All enrolled infants will participate in the trial for approximately 8 weeks.
- Conditions
- Probiotic Supplement
- Being tested
- High dose probiotic supplement, Low dose probiotic supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose probiotic supplementOther
One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
Low dose probiotic supplementOther
One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
PlaceboOther
One placebo stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | High dose probiotic supplement and maltodextrin as the excipient Receives: Other: High dose probiotic supplement |
| Experimental Group 2 | Experimental | Low dose probiotic supplement and maltodextrin as the excipient Receives: Other: Low dose probiotic supplement |
| Control Group | Placebo comparator | Placebo supplement containing only maltodextrin but having the same appearance as the probiotic supplements Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of high dose probiotic supplement (weight gain)
Compare the growth (weight gain, g/day) of formula-fed and/or breastfed infants in EG 1 vs. CG from enrolment to 8 weeks of intervention
Measured: Day 56
Secondary outcomes (1)
Efficacy of two different doses of probiotic supplement
Bifidobacteria abundance measured in the fecal sample collected at home after 8 weeks of intervention (V3) analyzed by next generation sequencing (NGS) technology.
Measured: Day 0, Day 25-27, Day 53-55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start26 Feb 2021
- Primary completion23 Aug 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Probiotic SupplementStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765852
- Sponsor's protocol ID
- 20.11.INF
- Status last verified
- Mar 2023
- First submitted
- 12 Nov 2020
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth, Safety and Efficacy of a Probiotic Supplement: a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04765852
- Acronym / sponsor ID
- 20.11.INF
- Conditions
- Probiotic Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 23 Feb 2021 (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 primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of intervention
Detailed description
This is a randomized, placebo-controlled, double-blind study of healthy term infants, consisting of three randomized arms: placebo control group, high dose experimental group, and low dose experimental group. The study population, approximately 228, are infants 14 - 21 days of age who are formula-fed and/or breastfed who is aligned with the intended target population for a probiotic supplement. Placebo and probiotic supplements will be mixed with formula or breastmilk and fed orally using a feeding cup or syringe. All enrolled infants will participate in the trial for approximately 8 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: High dose probiotic supplementHigh dose probiotic supplement and maltodextrin as the excipient |
| Experimental Group 2 | Experimental | Other: Low dose probiotic supplementLow dose probiotic supplement and maltodextrin as the excipient |
| Control Group | Placebo comparator | Other: PlaceboPlacebo supplement containing only maltodextrin but having the same appearance as the probiotic supplements |
Who may qualify
- Ages
- 14 to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study.
- Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
- Infants whose parent(s)/LAR have access to a working freezer.
Key exclusion criteria (9 listed)
- Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol.
- Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment.
- Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Infants who are presently receiving or have received prior to enrollment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
- Currently participating or having participated in another clinical trial since birth.
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 |
|---|---|---|
| High dose probiotic supplementOne probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56. | Other | Experimental Group 1 |
| Low dose probiotic supplementOne probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56. | Other | Experimental Group 2 |
| PlaceboOne placebo stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56. | Other | Control Group |
Primary outcome
Safety of high dose probiotic supplement (weight gain)
Time frame: Day 56
Compare the growth (weight gain, g/day) of formula-fed and/or breastfed infants in EG 1 vs. CG from enrolment to 8 weeks of intervention
1 secondary outcome
Efficacy of two different doses of probiotic supplement
Time frame: Day 0, Day 25-27, Day 53-55
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 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose probiotic supplement and Low dose probiotic supplement in people with Probiotic Supplement, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
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 11 inclusion and 9 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 24 Mar 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 Philippines. 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?
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?
Safety of high dose probiotic supplement (weight gain) (time frame: Day 56). 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 24 Mar 2023.