Gastrointestinal Symptoms in Young InfantsNCT01684319
Milk-induced Gastrointestinal Symptoms in Infants
A study testing Formula milk free of cow's milk protein in people with Gastrointestinal Symptoms in Young Infants, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family. In a prospective study on more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of these children had gastrointestinal symptoms… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Gastrointestinal Symptoms in Young Infants
- What is being tested?
- Formula milk free of cow's milk protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2012to Nov 2013
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants 0-6 month old with at least one of the following symptoms : constipation, gastroesophageal reflux, colics
Who cannot join
- Prematurity
- exclusive breastfeeding
- Other cause for symptoms
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Département de l'enfant et de l'adolesent - Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1211
About this study
Official title: Prospective, Randomized, Double Blind and Placebo Controlled Study With the Aim to Establish the Role of Milk Proteins in Gastrointestinal Diseases (GERD, Constipation and Colics) of Young Infants and to Determine the Diagnostic Value of Immunological Tests in These Pathologies.
Various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family. In a prospective study on more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%), constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate, and their cause is often difficult to determine. Frequently, the pediatrician will exclude cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked. This measure causes significant additional costs through the use of extensively hydrolyzed milk specifically for children and involves an elimination diet of all foods containing cow's milk sometimes for several years. This can negatively influence the growth of the child.
If the involvement of milk in these pathologies is suggested by some early studies (35% for colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an "allergy" to milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy. However, various tests have proven their effectiveness in the investigation of non IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.
- Being tested
- Formula milk free of cow's milk protein, Placebo
- Keywords
- Constipation, Gastroeosphageal reflux, Colics
- Medical subject headings
- Constipation, Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula milk free of cow's milk proteinDietary supplement
PlaceboDietary supplement
Infant formula milk
| Study group | Role | What they receive |
|---|---|---|
| Infant formula milk | Placebo comparator | Infant formula milk adapted to age of infant Receives: Dietary Supplement: Placebo |
| Formula milk free of milk proteins | Active comparator | Milk-free formula milk adapted to age of infant Receives: Dietary Supplement: Formula milk free of cow's milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milk allergy in gastrointestinal diseases in young infants
Establish the role of milk proteins in gastrointestinal diseases in young infants
Measured: 10 weeks
Secondary outcomes (1)
Diagnostic tests
Determine the diagnostic value of immunological tests in these pathologies
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Symptoms in Young InfantsStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Eigenmann, University Hospital, Geneva
- Investigators
- Philippe A Eigenmann, MD, Study director, Hôpitaux Unversitaire de Genève
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684319
- Sponsor's protocol ID
- 11-202 (MATPED 11-047)
- Status last verified
- Jan 2014
- First submitted
- 10 Sep 2012
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blind and Placebo Controlled Study With the Aim to Establish the Role of Milk Proteins in Gastrointestinal Diseases (GERD, Constipation and Colics) of Young Infants and to Determine the Diagnostic Value of Immunological Tests in These Pathologies.
- ClinicalTrials.gov ID
- NCT01684319
- Acronym / sponsor ID
- 11-202 (MATPED 11-047)
- Keywords
- Constipation, Gastroeosphageal reflux, Colics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Sep 2012 (estimated)
- 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.
Various digestive manifestations are common in infants less than 6 months and have a significant impact on morbidity and quality of life of the family. In a prospective study on more than 2800 Italian infants followed by 0-6 months of life, it was determined that 55% of these children had gastrointestinal symptoms such as regurgitation (23%), colics (20%), constipation (17%) or poor weight gain (15%). However, these symptoms are not very accurate, and their cause is often difficult to determine. Frequently, the pediatrician will exclude cow's milk protein in infant feeding, but without a clear etiological diagnosis was asked. This measure causes significant additional costs through the use of extensively hydrolyzed milk specifically for children and involves an elimination diet of all foods containing cow's milk sometimes for several years. This can negatively influence the growth of the child.
If the involvement of milk in these pathologies is suggested by some early studies (35% for colics, 68% in constipation, 42% in gastroesophageal reflux), it is unclear in the current state of knowledge if these gastrointestinal symptoms are actually due to an "allergy" to milk. Moreover, there is no validated diagnostic test for non-IgE-mediated gut allergy. However, various tests have proven their effectiveness in the investigation of non IgE-mediated allergy (eg. LAT, patch tests) and will be used in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant formula milk | Placebo comparator | Dietary Supplement: PlaceboInfant formula milk adapted to age of infant |
| Formula milk free of milk proteins | Active comparator | Dietary Supplement: Formula milk free of cow's milk proteinMilk-free formula milk adapted to age of infant |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants 0-6 month old with at least one of the following symptoms : constipation, gastroesophageal reflux, colics
Key exclusion criteria (3 listed)
- Prematurity
- exclusive breastfeeding
- Other cause for symptoms
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 |
|---|---|---|
| Formula milk free of cow's milk protein | Dietary supplement | Formula milk free of milk proteins |
| PlaceboInfant formula milk | Dietary supplement | Infant formula milk |
Primary outcome
Milk allergy in gastrointestinal diseases in young infants
Time frame: 10 weeks
Establish the role of milk proteins in gastrointestinal diseases in young infants
1 secondary outcome
Diagnostic tests
Time frame: 10 weeks
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 6 Jan 2014.
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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.
Philippe A Eigenmann, MD study director
Hôpitaux Unversitaire de Genève
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula milk free of cow's milk protein in people with Gastrointestinal Symptoms in Young Infants, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 3 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 6 Jan 2014. 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 Switzerland. 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?
Milk allergy in gastrointestinal diseases in young infants (time frame: 10 weeks). 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 6 Jan 2014.