Gastrointestinal DiseasesNCT06395571
GI Symptoms in Infants Fed GMF or CMF
A study testing Goat milk-based infant formula and Cow's milk-based infant formula in people with Gastrointestinal Diseases and Infant Nutrition Disorders, run by Ausnutria Hyproca B.V. at 1 site in Brazil.
Trial summary
The aim of this study was to assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based infant formula (GMF) compared to cow's milk-based infant formula (CMF) during a 24 week intervention. Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Infant Nutrition Disorders
- What is being tested?
- Goat milk-based infant formula and Cow's milk-based infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Apr 2019to 6 Oct 2019
- 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 3 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- gestational age 37-42 weeks
- 3-12 months old at enrollment
- should have consumed cow's milk-based products during the 48 hours prior to the baseline visit to exclude cow's milk allergic infants
Who cannot join
- metabolic or chronic disease or congenital malformation, serious concurrent illness that would interfere with study treatment, (i.e. sepsis, pneumonia with respiratory failure, cardiac failure)
- infant's parent(s) or primary caregiver(s) diagnosed with major depression
- infant's weight for length at baseline >|3| z-score indexes according to WHO criteria
- infants enrolled in another interventional clinical research study
- infants diagnosed with cow's milk allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula: a Double-blind, Randomized Controlled Trial
The aim of this study was to assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based infant formula (GMF) compared to cow's milk-based infant formula (CMF) during a 24 week intervention.
Read the detailed description
Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this double-blind, randomized controlled trial, gastrointestinal comfort in infants fed goat milk-based infant formula (GMF) or cow's milk-based infant formula (CMF) was studied.
Fifty-six healthy infants aged 3-12 months were followed for 24 weeks. Stool consistency, regurgitation frequency and crying duration were measured weekly using an adapted version of the Cow's Milk-related Symptom Score (CoMiSS®) where only the items for these scores were used. Blood hemoglobin levels were measured at the start and at the end of the intervention.
- Being tested
- Goat milk-based infant formula, Cow's milk-based infant formula
- Keywords
- goat milk-based infant formula, infant formula, gastrointestinal comfort, infant nutrition
- Medical subject headings
- Gastrointestinal Diseases, Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goat milk-based infant formulaDietary supplement
Goat milk-based infant formula fed at age appropriate quantities for 24 weeks
Cow's milk-based infant formulaDietary supplement
Cow's milk-based infant formula formula fed at age appropriate quantities for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Goat milk-based infant formula | Experimental | Experimental group receives goat milk-based formula for 24 weeks Receives: Dietary Supplement: Goat milk-based infant formula |
| Cow's milk-based infant formula | Active comparator | Control group receives cow's milk-based formula for 24 weeks Receives: Dietary Supplement: Cow's milk-based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
Stool consistency, regurgitation frequency and crying duration as measured by an adapted Cow's Milk-related Symptom Score®, where a higher score indicates more severe symptoms.
Measured: 24 weeks, measured weekly
Secondary outcomes (5)
Blood hemoglobin levels
Blood hemoglobin levels before and after intervention
Measured: 24 weeks, measured at start and end
WHO z-score of weight-for-age
Weight measured to the nearest 5.0 grams with clothes and diaper removed.
Measured: 24 weeks, measured monthly
WHO z-score of length-for-age
Body length without shoes, measured lying down to the nearest centimeter with a neonatometer.
Measured: 24 weeks, measured monthly
WHO z-score of head circumference-for-age
Head circumference measured with flexible non-stretching tape to the nearest centimeter.
Measured: 24 weeks, measured monthly
WHO z-score of weight-for-length
Weight and length measured as described above combined.
Measured: 24 weeks, measured monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start17 Apr 2019
- Primary completion6 Oct 2019
- Study completion6 Oct 2019
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 Gastrointestinal DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ausnutria Hyproca B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo da Costa Ribeiro, Dr., Principal investigator, Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395571
- Sponsor's protocol ID
- P19-009
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maximino P, van Lee L, Meijer-Krommenhoek YN, van der Zee L, da Costa Ribeiro Junior H. Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow's milk-based formula: a double-blind, randomized, controlled trial. BMC Pediatr. 2024 Nov 20;24(1):753. doi: 10.1186/s12887-024-05214-y.
PubMed 39567910
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula: a Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06395571
- Acronym / sponsor ID
- P19-009
- Keywords
- goat milk-based infant formula, infant formula, gastrointestinal comfort, infant nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ausnutria Hyproca B.V.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 6 Oct 2019 (actual)
- Study completion
- 6 Oct 2019 (actual)
- First posted
- 2 May 2024 (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 aim of this study was to assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based infant formula (GMF) compared to cow's milk-based infant formula (CMF) during a 24 week intervention.
Detailed description
Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this double-blind, randomized controlled trial, gastrointestinal comfort in infants fed goat milk-based infant formula (GMF) or cow's milk-based infant formula (CMF) was studied.
Fifty-six healthy infants aged 3-12 months were followed for 24 weeks. Stool consistency, regurgitation frequency and crying duration were measured weekly using an adapted version of the Cow's Milk-related Symptom Score (CoMiSS®) where only the items for these scores were used. Blood hemoglobin levels were measured at the start and at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Goat milk-based infant formula | Experimental | Dietary Supplement: Goat milk-based infant formulaExperimental group receives goat milk-based formula for 24 weeks |
| Cow's milk-based infant formula | Active comparator | Dietary Supplement: Cow's milk-based infant formulaControl group receives cow's milk-based formula for 24 weeks |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- gestational age 37-42 weeks
- 3-12 months old at enrollment
- should have consumed cow's milk-based products during the 48 hours prior to the baseline visit to exclude cow's milk allergic infants
Key exclusion criteria (5 listed)
- metabolic or chronic disease or congenital malformation, serious concurrent illness that would interfere with study treatment, (i.e. sepsis, pneumonia with respiratory failure, cardiac failure)
- infant's parent(s) or primary caregiver(s) diagnosed with major depression
- infant's weight for length at baseline >|3| z-score indexes according to WHO criteria
- infants enrolled in another interventional clinical research study
- infants diagnosed with cow's milk allergies
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 |
|---|---|---|
| Goat milk-based infant formulaGoat milk-based infant formula fed at age appropriate quantities for 24 weeks | Dietary supplement | Goat milk-based infant formula |
| Cow's milk-based infant formulaCow's milk-based infant formula formula fed at age appropriate quantities for 24 weeks | Dietary supplement | Cow's milk-based infant formula |
Primary outcome
Gastrointestinal symptoms
Time frame: 24 weeks, measured weekly
Stool consistency, regurgitation frequency and crying duration as measured by an adapted Cow's Milk-related Symptom Score®, where a higher score indicates more severe symptoms.
5 secondary outcomes
Blood hemoglobin levels
Time frame: 24 weeks, measured at start and end
WHO z-score of weight-for-age
Time frame: 24 weeks, measured monthly
WHO z-score of length-for-age
Time frame: 24 weeks, measured monthly
WHO z-score of head circumference-for-age
Time frame: 24 weeks, measured monthly
WHO z-score of weight-for-length
Time frame: 24 weeks, measured monthly
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 2 May 2024.
- Derived from this study: PubMed 39567910Maximino P, van Lee L, Meijer-Krommenhoek YN, van der Zee L, da Costa Ribeiro Junior H. Common gastrointestinal symptoms in healthy infants receiving goat milk-based formula or cow's milk-based formula: a double-blind, randomized, controlled trial. BMC Pediatr. 2024 Nov 20;24(1):753. doi: 10.1186/s12887-024-05214-y.
- 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.
Hugo da Costa Ribeiro, Dr. principal investigator
Hospital Professor Edgard Santos, Federal University of Bahia, Salvador, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goat milk-based infant formula and Cow's milk-based infant formula in people with Gastrointestinal Diseases and Infant Nutrition Disorders, run by Ausnutria Hyproca B.V. at 1 site in Brazil.
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 3 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 2 May 2024. 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 Brazil. 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 symptoms (time frame: 24 weeks, measured weekly). 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 NCT06395571, 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 May 2024.