Milk HypersensitivityPEPSYNCT04893330
Interest of Peticate Syneo Infant Formula in Children Allergic to Cow's Milk Protein: Real Life Study
An observational study of Milk Hypersensitivity, run by Nutricia Nutrition Clinique at 1 site in France.
Trial summary
Nutricia wants to launch a real-life study, to see how the presence of prebiotics and probiotics in the boosted protein hydrolyzate can improve symptoms in the first weeks of use, and supplement the efficacy and safety data of the drug. formula, collected during clinical trials, with real life use. Read more about this study
- Who is it for?
- Ages 8 months and olderHealthy volunteers can take part
- Conditions the study is for
- Milk Hypersensitivity
- What is being tested?
- pepticate syneo
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2021to 30 May 2022
- Phase
- Observational
- 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 8 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The target population is made up of children under 8 months of age at inclusion, with a diagnosis or strong suspicion of APLV. The study plans to include 78 patients.
Who may be able to join
- Child aged ≤ 8 months;
- Child newly diagnosed with an allergy to cow's milk proteins (APLV), or with a strong suspicion of APLV (mediated by IgE or not), justifying (according to the doctor) the prescription of Pepticate® Syneo® (extensive hydrolyzate cow's milk protein)
- Child already fed with an infant formula (partially or totally), or whose parents have already made the decision to initiate an infant formula, in addition to or as a follow-up to breastfeeding.
- Authorization of one or more parents or the child's legal representative to collect personal information about the child and the family.
Who cannot join
- Child who has already taken an infant formula such as "high protein hydrolyzate" or "amino acid formula";
- Child with a contraindication to taking symbiotics (eg: short bowel syndrome, parenteral nutrition, post-pyloric nutrition, central venous catheter, etc.)
- Child with severe APLV requiring the prescription of an amino acid formula;
- Legal guardian of the protected child (under legal protection, or deprived of liberty by judicial or administrative decision);
- Legal guardian of the child who is not a beneficiary of a social security scheme.
- Inability of the legal representative to understand the study protocol, or doctor's doubts about the ability of the will to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Nutricia wants to launch a real-life study, to see how the presence of prebiotics and probiotics in the boosted protein hydrolyzate can improve symptoms in the first weeks of use, and supplement the efficacy and safety data of the drug. formula, collected during clinical trials, with real life use. The target population will be children with a definite or suspected diagnosis of APLV, who have never taken a hypoallergenic formula, for whom the doctor decides to prescribe the Pepsicate Syneo formula, regardless of the clinical manifestation of the allergy. These children will be included before the age of 8 months and will be seen again 4 weeks after the prescription. The data from this real-life study will also better characterize the profile of infants taking Pepsicate Syneo. Finally, the perception of the formula by the parents will be collected.
Read the detailed description
Nutricia has developed an infant formula intended for children, APLV, from the class of foodstuffs intended for special medical purposes (DADFMS), called Pepticate Syneo. This hypoallergenic formula is based on high hydrolyzate of whey protein. It also contains:
- IcFOS and scGOS prebiotic fibers. These oligosaccharides are well tolerated and promote the induction of a favorable gut microbiota and an improvement in faecal characteristics [Arslanoglu 2008, Moro 2006].
- The probiotic strain Bifidobaterium Breve M-16V. B. breve is the most common species of bifidobacteria in human milk [Martin 2009]. The B. breve M16-V strain, isolated from the stool of a healthy infant, is approved in food by health authorities and conforms to the recommendations of the American Academy of Pediatrics [2000]. It helps promote the implantation of beneficial bacteria in the intestinal microbiota of young children [Akiyama 1994, Taniuchi 2005, van der Aa 2010]. Preclinical data suggest that it reduces the allergic immune response [Hougee 2010, Inoue 2009]. In clinical studies, it helps reduce atopic dermatitis in children with APLV [Hattori 2003, Taniuchi 2005]. In addition, the prebiotic / probiotic combination (also called symbiotic) shows a synergistic effect in mice in reducing allergic manifestations [Schouten 2009]. Used in children born by cesarean section, it helps restore intestinal colonization by bifidobacteria, to a level similar to that of infants born vaginally and breastfed [Chua 2017].
In babies with a suspicion of non-IgE-mediated APLV, this symbiotic mixture (IcFOS, scGOS and B. Breve) allowed a modification of the fecal microbiota in 8 weeks, thus approaching the microbiota of breastfed infants of the same age, with an increase in Bifidobacteria and a decrease in Eubacterium rectale / Clostridium coccoides [Fox 2019].
All the available scientific data suggest an excellent tolerance of the Pepticate Syneo formula, and therapeutic efficacy on the manifestations of APLV, whether or not it is mediated by IgE, while ensuring the nutritional needs of children's growth. [Abrahamse-Berkeveld 2016, Giampietro 2001, Vandenplas 1993, Verwimp 1995].
- Conditions
- Milk Hypersensitivity
- Being tested
- pepticate syneo
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pepticate syneoDietary supplement
follow up of pepticate syneo for one month
| Study group | Role | What they receive |
|---|---|---|
| patients | children under 8 months of age at inclusion, with a diagnosis or strong suspicion of APLV Receives: Dietary Supplement: pepticate syneo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on general condition
Assessment of the effect of the PEPTICATE SYNEO formula on the evolution of the general condition of a child with a PPLA using a 4-level Likert scale (worse / identical / improved / resolved)
Measured: Day 28
Secondary outcomes (6)
Effect on evolution of allergic symptoms
Evaluation of the effect of the PEPTICATE SYNEO formula on the evolution of allergy symptoms using a 4-level Likert scale (worse / identical / improved / resolved)
Measured: Day 28
effect on evolution of allergic symptoms according to Parents
Assessment of the effect of the PEPTICATE SYNEO formula on the evolution of allergy symptoms according to the parents using a 4-level Likert scale (worse / identical / improved / resolved)
Measured: during one month
acceptability
Descriptive analysis of the acceptability of PEPTICATE SYNEO by parents using a questionnaire
Measured: Day 28
Parent's quality of life
The quality of life of the parents (FAQL-PB score) will be measured by a Student test on paired samples.
Measured: Day 28
CLINICAL PROFILE OF CHILDREN
Description of the clinical profile of the children at inclusion (Age, anthropometric data; growth; Food history, Risk factors for atopy..).
Measured: Day 0
Consumption of the formula
Evaluation of the infant formula consumption of children before inclusion and during follow-up (lasting 28 days).
Measured: during one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start23 Jun 2021
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk HypersensitivityStudies 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
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Nutrition Clinique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893330
- Sponsor's protocol ID
- 2021- A00703-38
- Acronym
- PEPSY
- Status last verified
- Apr 2022
- First submitted
- 7 May 2021
- Last updated
- 22 Sep 2023
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Peticate Syneo Infant Formula in Children Allergic to Cow's Milk Protein: Real Life Study
- ClinicalTrials.gov ID
- NCT04893330
- Acronym / sponsor ID
- PEPSY / 2021- A00703-38
- Conditions
- Milk Hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Nutricia Nutrition CliniqueIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 19 May 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.
Nutricia wants to launch a real-life study, to see how the presence of prebiotics and probiotics in the boosted protein hydrolyzate can improve symptoms in the first weeks of use, and supplement the efficacy and safety data of the drug. formula, collected during clinical trials, with real life use. The target population will be children with a definite or suspected diagnosis of APLV, who have never taken a hypoallergenic formula, for whom the doctor decides to prescribe the Pepsicate Syneo formula, regardless of the clinical manifestation of the allergy. These children will be included before the age of 8 months and will be seen again 4 weeks after the prescription. The data from this real-life study will also better characterize the profile of infants taking Pepsicate Syneo. Finally, the perception of the formula by the parents will be collected.
Detailed description
Nutricia has developed an infant formula intended for children, APLV, from the class of foodstuffs intended for special medical purposes (DADFMS), called Pepticate Syneo. This hypoallergenic formula is based on high hydrolyzate of whey protein. It also contains:
- IcFOS and scGOS prebiotic fibers. These oligosaccharides are well tolerated and promote the induction of a favorable gut microbiota and an improvement in faecal characteristics [Arslanoglu 2008, Moro 2006].
- The probiotic strain Bifidobaterium Breve M-16V. B. breve is the most common species of bifidobacteria in human milk [Martin 2009]. The B. breve M16-V strain, isolated from the stool of a healthy infant, is approved in food by health authorities and conforms to the recommendations of the American Academy of Pediatrics [2000]. It helps promote the implantation of beneficial bacteria in the intestinal microbiota of young children [Akiyama 1994, Taniuchi 2005, van der Aa 2010]. Preclinical data suggest that it reduces the allergic immune response [Hougee 2010, Inoue 2009]. In clinical studies, it helps reduce atopic dermatitis in children with APLV [Hattori 2003, Taniuchi 2005]. In addition, the prebiotic / probiotic combination (also called symbiotic) shows a synergistic effect in mice in reducing allergic manifestations [Schouten 2009]. Used in children born by cesarean section, it helps restore intestinal colonization by bifidobacteria, to a level similar to that of infants born vaginally and breastfed [Chua 2017].
In babies with a suspicion of non-IgE-mediated APLV, this symbiotic mixture (IcFOS, scGOS and B. Breve) allowed a modification of the fecal microbiota in 8 weeks, thus approaching the microbiota of breastfed infants of the same age, with an increase in Bifidobacteria and a decrease in Eubacterium rectale / Clostridium coccoides [Fox 2019].
All the available scientific data suggest an excellent tolerance of the Pepticate Syneo formula, and therapeutic efficacy on the manifestations of APLV, whether or not it is mediated by IgE, while ensuring the nutritional needs of children's growth. [Abrahamse-Berkeveld 2016, Giampietro 2001, Vandenplas 1993, Verwimp 1995].
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Dietary Supplement: pepticate syneochildren under 8 months of age at inclusion, with a diagnosis or strong suspicion of APLV |
Who may qualify
- Ages
- 8 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population is made up of children under 8 months of age at inclusion, with a diagnosis or strong suspicion of APLV. The study plans to include 78 patients.
Key inclusion criteria (4 listed)
- Child aged ≤ 8 months;
- Child newly diagnosed with an allergy to cow's milk proteins (APLV), or with a strong suspicion of APLV (mediated by IgE or not), justifying (according to the doctor) the prescription of Pepticate® Syneo® (extensive hydrolyzate cow's milk protein)
- Child already fed with an infant formula (partially or totally), or whose parents have already made the decision to initiate an infant formula, in addition to or as a follow-up to breastfeeding.
- Authorization of one or more parents or the child's legal representative to collect personal information about the child and the family.
Key exclusion criteria (6 listed)
- Child who has already taken an infant formula such as "high protein hydrolyzate" or "amino acid formula";
- Child with a contraindication to taking symbiotics (eg: short bowel syndrome, parenteral nutrition, post-pyloric nutrition, central venous catheter, etc.)
- Child with severe APLV requiring the prescription of an amino acid formula;
- Legal guardian of the protected child (under legal protection, or deprived of liberty by judicial or administrative decision);
- Legal guardian of the child who is not a beneficiary of a social security scheme.
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 |
|---|---|---|
| pepticate syneofollow up of pepticate syneo for one month | Dietary supplement | patients |
Primary outcome
effect on general condition
Time frame: Day 28
Assessment of the effect of the PEPTICATE SYNEO formula on the evolution of the general condition of a child with a PPLA using a 4-level Likert scale (worse / identical / improved / resolved)
6 secondary outcomes
Effect on evolution of allergic symptoms
Time frame: Day 28
effect on evolution of allergic symptoms according to Parents
Time frame: during one month
acceptability
Time frame: Day 28
Parent's quality of life
Time frame: Day 28
CLINICAL PROFILE OF CHILDREN
Time frame: Day 0
Consumption of the formula
Time frame: during 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 22 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Milk Hypersensitivity, run by Nutricia Nutrition Clinique at 1 site in France.
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 4 inclusion and 6 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 22 Sep 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 France. 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?
effect on general condition (time frame: Day 28). 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 22 Sep 2023.