Gastrointestinal SymptomsMESK-1NCT06744699
Assessment of Gastrointestinal Discomfort and Infections in Healthy Term Infants
An observational study of Gastrointestinal Symptoms and Infection, run by Ausnutria Hyproca B.V. at 3 sites in Saudi Arabia.
Trial summary
A retrospective observational medical dossier-based study to assess gastrointestinal discomfort and infections in healthy term infants Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms, Infection, Allergy Symptoms
- What is being tested?
- Infants fed goat milk-based infant formula
- How many people
- 300 participants
- Where
- 3 sitesSaudi Arabia
- Study dates
- 18 Nov 2024to Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consists of 300 healthy term infants with medical dossiers covering the period of 0-12 months of age and at least 6 clinic visits.
Who may be able to join
- Either exclusively formula fed (GMF or CMF; consumption of HM ≤2 weeks is allowed for formula fed infants) OR exclusively breastfed before introduction of complementary feeding.
- Age 12-24 months of age to ensure collection of recent data.
- If required by local regulation or guidelines, written informed consent (ICF) from Investigator (or parent(s) and/or caregiver(s)* aged ≥18 years).
- Singleton, term infants (gestational age ≥ 37 weeks and ≤ 42 weeks).
- At least 6 reported visits to the doctor between 0-12 months of age.
Who cannot join
- Consumed hydrolysed infant formula or other specialty formulas.
- Any current or previous illnesses/conditions and/or known congenital diseases or malformations which could interfere with the study outcomes, as per Investigator's clinical judgement.
- Participation in any clinical trial during first year of life.
- For formula-fed infant, no switch in feeding type after 4 months of age is allowed.
Trial locations and contacts
3 sites in 1 country.
Saudi Arabia3 sites
Al Emies hospital
Jizan
Mana GH Jubail
Jubail
AlAhmady Hospital
Madinah
About this study
Official title: A Retrospective Observational Medical Dossier-based Study to Assess Gastrointestinal Discomfort and Infections in Healthy Term Infants
A retrospective observational medical dossier-based study to assess gastrointestinal discomfort and infections in healthy term infants
Read the detailed description
Gastrointestinal (GI) symptoms like regurgitation, unexplained crying and stool issues (diarrhoea or constipation) are common in young infants <4 months of age due to an immature gut epithelial barrier, immune system and microbiota, with studies indicating prevalences ranging from 25.9%-78%. This retrospective observational medical dossier-based study is designed to determine the occurrence of GI symptoms in healthy term formula-fed infants to confirm reported prevalence of mild GI symptoms by HCPs in Middle East (74%). As a secondary objective, the improvement of confirmed GI symptoms when switched before 4 months of age from a CMF to GMF will be determined. Based on the results of a previous study in infants with confirmed GI symptoms, it is expected that fewer GI symptoms will be scored in medical dossiers of infants after switching from CMF to GMF, with HM as a reference group. Other secondary objectives of this study are to explore differences between healthy term infants that were fed GMF compared to infants fed CMF or HM on immune related outcomes such as infections and allergies, medication use related to infections and/or gastrointestinal discomfort and/or allergies, number of clinic visits, adequate growth and reason of changing infant formula.
- Conditions
- Gastrointestinal Symptoms, Infection, Allergy Symptoms, Growth
- Being tested
- Infants fed goat milk-based infant formula
- Keywords
- infant, retrospective, medical dossier-based study, GI symptoms, infection symptoms, allergy symptoms, type of feeding, growth
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infants fed goat milk-based infant formulaOther
Also called Infants fed cow's milk based infant formula, Infants breastfed / human milk feeding
Type of infant feeding during the age of 0-12 months
| Study group | Role | What they receive |
|---|---|---|
| Formula-fed infants | Formula-fed infants either goat milk-based infant formula or cow's milk-based infant formula Receives: Other: Infants fed goat milk-based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the occurrence of symptoms related to GI discomfort in formula-fed infants in the Gulf region
To determine the number of symptoms related to GI discomfort in formula-fed infants between 0-12 months of age
Measured: retrospective infants from 0 - 12 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 posted20 Dec 2024
- Study start18 Nov 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ausnutria Hyproca B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744699
- Sponsor's protocol ID
- P24-151
- Acronym
- MESK-1
- Status last verified
- Dec 2024
- First submitted
- 19 Nov 2024
- Last updated
- 20 Dec 2024
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Medical Dossier-based Study to Assess Gastrointestinal Discomfort and Infections in Healthy Term Infants
- ClinicalTrials.gov ID
- NCT06744699
- Acronym / sponsor ID
- MESK-1 / P24-151
- Conditions
- Gastrointestinal Symptoms, Infection, Allergy Symptoms, Growth
- Keywords
- infant, retrospective, medical dossier-based study, GI symptoms, infection symptoms, allergy symptoms, type of feeding, growth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ausnutria Hyproca B.V.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 20 Dec 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.
A retrospective observational medical dossier-based study to assess gastrointestinal discomfort and infections in healthy term infants
Detailed description
Gastrointestinal (GI) symptoms like regurgitation, unexplained crying and stool issues (diarrhoea or constipation) are common in young infants <4 months of age due to an immature gut epithelial barrier, immune system and microbiota, with studies indicating prevalences ranging from 25.9%-78%. This retrospective observational medical dossier-based study is designed to determine the occurrence of GI symptoms in healthy term formula-fed infants to confirm reported prevalence of mild GI symptoms by HCPs in Middle East (74%). As a secondary objective, the improvement of confirmed GI symptoms when switched before 4 months of age from a CMF to GMF will be determined. Based on the results of a previous study in infants with confirmed GI symptoms, it is expected that fewer GI symptoms will be scored in medical dossiers of infants after switching from CMF to GMF, with HM as a reference group. Other secondary objectives of this study are to explore differences between healthy term infants that were fed GMF compared to infants fed CMF or HM on immune related outcomes such as infections and allergies, medication use related to infections and/or gastrointestinal discomfort and/or allergies, number of clinic visits, adequate growth and reason of changing infant formula.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formula-fed infants | – | Other: Infants fed goat milk-based infant formulaFormula-fed infants either goat milk-based infant formula or cow's milk-based infant formula |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consists of 300 healthy term infants with medical dossiers covering the period of 0-12 months of age and at least 6 clinic visits.
Key inclusion criteria (5 listed)
- Either exclusively formula fed (GMF or CMF; consumption of HM ≤2 weeks is allowed for formula fed infants) OR exclusively breastfed before introduction of complementary feeding.
- Age 12-24 months of age to ensure collection of recent data.
- If required by local regulation or guidelines, written informed consent (ICF) from Investigator (or parent(s) and/or caregiver(s)* aged ≥18 years).
- Singleton, term infants (gestational age ≥ 37 weeks and ≤ 42 weeks).
- At least 6 reported visits to the doctor between 0-12 months of age.
Key exclusion criteria (4 listed)
- Consumed hydrolysed infant formula or other specialty formulas.
- Any current or previous illnesses/conditions and/or known congenital diseases or malformations which could interfere with the study outcomes, as per Investigator's clinical judgement.
- Participation in any clinical trial during first year of life.
- For formula-fed infant, no switch in feeding type after 4 months of age is allowed.
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 |
|---|---|---|
| Infants fed goat milk-based infant formulaAlso: Infants fed cow's milk based infant formula, Infants breastfed / human milk feedingType of infant feeding during the age of 0-12 months | Other | Formula-fed infants |
Primary outcome
To investigate the occurrence of symptoms related to GI discomfort in formula-fed infants in the Gulf region
Time frame: retrospective infants from 0 - 12 months of age
To determine the number of symptoms related to GI discomfort in formula-fed infants between 0-12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- 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?
An observational study of Gastrointestinal Symptoms and Infection, run by Ausnutria Hyproca B.V. at 3 sites in Saudi Arabia.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Dec 2024. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
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?
To investigate the occurrence of symptoms related to GI discomfort in formula-fed infants in the Gulf region (time frame: retrospective infants from 0 - 12 months of age). 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 20 Dec 2024.