Gastrointestinal ToleranceTREENCT04745455
Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics.
A study testing Infant formula containing prebiotics, probiotics and postbiotics in people with Gastrointestinal Tolerance, run by Nutricia Research at 3 sites in Poland.
Trial summary
A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics. Read more about this study
- Who is it for?
- Ages 14 to 84 daysHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Infant formula containing prebiotics, probiotics and postbiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesPoland
- Study dates
- 22 Jan 2021to 12 Jul 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 84 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days;
- Singleton, healthy infants as judged by the principle investigator;
- Infants with age at screening ≥2 weeks (14 days) and ≤ 12 weeks (84 days)
- Infants who are fully formula fed for at least 1 week prior to screening and whose parents have autonomously decided to fully formula feed, i.e. not to breastfeed or have ended breastfeeding, and who are intending to fully formula feed;
- Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.
Who cannot join
- Infants who require to be fed a special diet other than standard cow's milk-based infant formula;
- Infants known to have or suspected to have cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients;
- Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters, such as but not limited to: GI malformations, congenital metabolic disorders, severe congenital cardiac disorders, immunodeficiency or major surgery, as per the clinical judgment of the Investigator;
- Infants diagnosed with a gastrointestinal infection within 4 weeks prior to screening;
- Infants with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator;
- Received any of the following products/medication prior to screening: systemic antibiotics, prokinetics, proton pump inhibitors, prebiotic supplements, probiotic supplements, complementary feeding/weaning within 4 weeks prior to screening;
Show all 9Show fewer
- Incapability of infants' parents to comply with study protocol as per the judgment of the Investigator (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection);
- Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study.
- -
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
Bialystok, 15-435
Izabela Tarczoń Przylądek Zdrowia Specjalistyczne Poradnie Medyczne
Krakow, 30-324
NZLA Michalkowice Jarosz i partnerzy Spolka
Siemianowice Śląskie, 41-103
About this study
Official title: An Open-label Single-arm Study to Investigate Gastrointestinal Tolerance, Safety, and Acceptability of a New Infant Formula Containing Prebiotics, Probiotics and Postbiotics, in Healthy Term Infants.
A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Infant formula containing prebiotics, probiotics and postbiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula containing prebiotics, probiotics and postbioticsOther
Infant formula containing prebiotics, probiotics and postbiotics
| Study group | Role | What they receive |
|---|---|---|
| Cow's milk based infant formula containing prebiotics, probiotics and postbiotics | Other | Not described Receives: Other: Infant formula containing prebiotics, probiotics and postbiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Measured: Baseline
Gastrointestinal tolerance
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Measured: Day 7
Gastrointestinal tolerance
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Measured: Day 14
Gastrointestinal tolerance
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Measured: Day 21
Gastrointestinal tolerance
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Measured: Day 28
Secondary outcomes (11)
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Measured: Baseline
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Measured: Day 7
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Measured: Day 14
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Measured: Day 21
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Measured: Day 28
Stool frequency
Parent reported daily number of stools
Measured: Baseline
Stool frequency
Parent reported daily number of stools
Measured: Day 7
Stool frequency
Parent reported daily number of stools
Measured: Day 14
Stool frequency
Parent reported daily number of stools
Measured: Day 21
Stool frequency
Parent reported daily number of stools
Measured: Day 28
Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events.
(S)AE collection
Measured: Through study completion, an average of one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start22 Jan 2021
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745455
- Sponsor's protocol ID
- SBB20R&32116
- Acronym
- TREE
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 25 Jan 2022
- 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single-arm Study to Investigate Gastrointestinal Tolerance, Safety, and Acceptability of a New Infant Formula Containing Prebiotics, Probiotics and Postbiotics, in Healthy Term Infants.
- ClinicalTrials.gov ID
- NCT04745455
- Acronym / sponsor ID
- TREE / SBB20R&32116
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 9 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.
A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cow's milk based infant formula containing prebiotics, probiotics and postbiotics | Other | Other: Infant formula containing prebiotics, probiotics and postbiotics |
Who may qualify
- Ages
- 14 to 84 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days;
- Singleton, healthy infants as judged by the principle investigator;
- Infants with age at screening ≥2 weeks (14 days) and ≤ 12 weeks (84 days)
- Infants who are fully formula fed for at least 1 week prior to screening and whose parents have autonomously decided to fully formula feed, i.e. not to breastfeed or have ended breastfeeding, and who are intending to fully formula feed;
- Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.
Key exclusion criteria (9 listed)
- Infants who require to be fed a special diet other than standard cow's milk-based infant formula;
- Infants known to have or suspected to have cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients;
- Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters, such as but not limited to: GI malformations, congenital metabolic disorders, severe congenital cardiac disorders, immunodeficiency or major surgery, as per the clinical judgment of the Investigator;
- Infants diagnosed with a gastrointestinal infection within 4 weeks prior to screening;
- Infants with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator;
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 |
|---|---|---|
| Infant formula containing prebiotics, probiotics and postbioticsInfant formula containing prebiotics, probiotics and postbiotics | Other | Cow's milk based infant formula containing prebiotics, probiotics and postbiotics |
Primary outcome
Gastrointestinal tolerance
Time frame: Baseline
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Gastrointestinal tolerance
Time frame: Day 7
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Gastrointestinal tolerance
Time frame: Day 14
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Gastrointestinal tolerance
Time frame: Day 21
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
Gastrointestinal tolerance
Time frame: Day 28
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
11 secondary outcomes
Stool consistency
Time frame: Baseline
Stool consistency
Time frame: Day 7
Stool consistency
Time frame: Day 14
Stool consistency
Time frame: Day 21
Stool consistency
Time frame: Day 28
Stool frequency
Time frame: Baseline
Stool frequency
Time frame: Day 7
Stool frequency
Time frame: Day 14
Stool frequency
Time frame: Day 21
Stool frequency
Time frame: Day 28
Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events.
Time frame: Through study completion, an average of one month
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 25 Jan 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula containing prebiotics, probiotics and postbiotics in people with Gastrointestinal Tolerance, run by Nutricia Research at 3 sites in Poland.
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 5 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 25 Jan 2022. 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 Poland. 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?
Gastrointestinal tolerance (time frame: Baseline). The study lists 5 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 25 Jan 2022.