Gastrointestinal DisorderPROBIOTOLERANCT04021303
Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response
A study testing Experimental cereal and Conventional cereal in people with Gastrointestinal Disorder and Immunologic Diseases in Children, run by Laboratorios Ordesa at 1 site in Spain.
Trial summary
This study will assess the development of gastrointestinal health in terms of digestive tolerability and immune-inflammatory response at the intestinal level comparing a conventional gluten-free cereal with a new cereal with prebiotics, probiotics and a very moderate amount of gluten. Read more about this study
- Who is it for?
- Ages 4 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Disorder, Immunologic Diseases in Children
- What is being tested?
- Experimental cereal and Conventional cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2019to Jun 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 4 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants (>37 weeks) vaginal delivery
- Adequate birth weight for gestational age (10-90 percentile)
- Infants with normal growth curve (10-90 percentile)
- Infants who were breastfeeding for at least 4 weeks, and at least half of the takes have been by breastfeeding.
- Infants aged 4 months (+/- 1 week) at the time of study inclusion no longer following breastfeeding, or mixed breastfeeding and if they are breast-feeding, no more than one shot a day.
- Availability to continue throughout the study period.
- Signature of informed consent by partents/guardians.
Who cannot join
- Infants who were born by cesarean section
- Infants born from preconception obese mothers
- Infants born from diabetic mothers or mothers with gestational diabetes
- Infants with a family history of celiac disease (parents or siblings)
- Infants who have had or have some type of allergic manifestation or allergic pathology
- Infants who have needed antibiotic treatment or have received some type of probiotic (the week before inclusion)
Show all 10Show fewer
- Infants with malformations, diseases or conditions and physical disabilities that cause changes in growth and/or nutritional status
- Infants diagnosed with any immune system-related disease (primary immunodeficiency)
- Infants with a known allergy and/or intolerance to cow's milk protein
- Parents' inability to follow study (at the discretion of the researcher)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Facultad de Medicina
Granada, 18071
Cristina Campoy, Professor, 607631601, ccampoy@ugr.es
Angela Muñoz, PHd Student, 664090546, angela.munozma@gmail.com
About this study
Official title: Study of the Initiation of Complementary Feeding With a Whole Grain, Gluten-containing Infant Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response at the Intestinal Level.
This study will assess the development of gastrointestinal health in terms of digestive tolerability and immune-inflammatory response at the intestinal level comparing a conventional gluten-free cereal with a new cereal with prebiotics, probiotics and a very moderate amount of gluten. These are products adapted to infant feeding since 4 Months.
Read the detailed description
In 2008 the ESPGHAN recommended not to give gluten cereals before 4 months but not after 7 months. Although the introduction of gluten in this window was linked to a posible preventive effect on celiac disease, the truth is that it has not been demonstrated. In any case, high exposures to gluten since the 4 months have been associated with a higher incidence of celiac disease and current recommendations propose moderate and progressive exposure to gluten between 4 and 6 months old.
- Being tested
- Experimental cereal, Conventional cereal
- Keywords
- Gluten, Probiotic, Prebiotic
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental cerealDietary supplement
Cereal containing probiotics, prebiotic fiber and low carbohydrates
Conventional cerealDietary supplement
Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cereal | Experimental | Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study. Receives: Dietary Supplement: Experimental cereal |
| Conventional cereal | Active comparator | Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old. Receives: Dietary Supplement: Conventional cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digestive tolerance
Infant Gastrointestinal Symptom Questionnaire (IGSQ) developed by Riley et al. to be completed by parents/guardians. It contains 13 ítems.For each item there are 5 possible answers in gradation 1 to 5 points and the result is the sum of all of them with minimum scores of 13 (maximum health status) and maximum of 65
Measured: From 4 to 12 months old
Secondary outcomes (11)
Assessing infant feeding habits
Analysis of daily intake through a record of food consumption for 24 hours
Measured: At 4, 5, 6, 9 and 12 months old
Infant microbiota study
Composition, diversity of microbiota. This procedure will be performed by studying samples of feces.
Measured: Stool sample collected at 4, 6 and 12 months old.
Assessment of intestinal health
Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination
Measured: Stool sample collected at 4, 6 and 12 months old.
Assessment of immune-inflammatory response
Record of the IgA secreted in saliva
Measured: At 4, 6 and 12 months old.
Infant infection episodes
Specific parent-reported infant symptoms of mild respiratory, gastrointestinal, skin and oropharyngeal infections. Parents will have a dairy to report all symptoms.
Measured: At 4, 5, 6, 9 and 12 months old.
Assessment of infant growth: weight
Weight measurements in grams to report anthropometric measures
Measured: At 4, 5, 6, 9 and 12 months old.
Assessment of infant growth: lenght
Lenght measurements in centimeters to report anthropometric measures
Measured: At 4, 5, 6, 9 and 12 months old.
Assessment of infant growth: cephalic perimeter
Cephalic perimeter measurements in centimeters to report anthropometric measures
Measured: At 4, 5, 6, 9 and 12 months old.
Evolution of body composition
Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer)
Measured: At 4, 5, 6, 9 and 12 months old
Medical history
Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest
Measured: At 4 months old
Demographics
Parents' age, parent education level, habits and parents lifestyle, home and social environment
Measured: At 4 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Sep 2019
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Ordesa
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Sponsor
- Investigators
- Cristina Campoy, Professor, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021303
- Sponsor's protocol ID
- PROBIO-TOLERA
- Acronym
- PROBIOTOLERA
- Status last verified
- Dec 2020
- First submitted
- 5 Jul 2019
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Initiation of Complementary Feeding With a Whole Grain, Gluten-containing Infant Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response at the Intestinal Level.
- ClinicalTrials.gov ID
- NCT04021303
- Acronym / sponsor ID
- PROBIOTOLERA / PROBIO-TOLERA
- Keywords
- Gluten, Probiotic, Prebiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Laboratorios OrdesaIndustry (pharma, biotech, devices)
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Jul 2019 (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.
This study will assess the development of gastrointestinal health in terms of digestive tolerability and immune-inflammatory response at the intestinal level comparing a conventional gluten-free cereal with a new cereal with prebiotics, probiotics and a very moderate amount of gluten. These are products adapted to infant feeding since 4 Months.
Detailed description
In 2008 the ESPGHAN recommended not to give gluten cereals before 4 months but not after 7 months. Although the introduction of gluten in this window was linked to a posible preventive effect on celiac disease, the truth is that it has not been demonstrated. In any case, high exposures to gluten since the 4 months have been associated with a higher incidence of celiac disease and current recommendations propose moderate and progressive exposure to gluten between 4 and 6 months old.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Cereal | Experimental | Dietary Supplement: Experimental cerealExperimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study. |
| Conventional cereal | Active comparator | Dietary Supplement: Conventional cerealConventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old. |
Who may qualify
- Ages
- 4 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy term infants (>37 weeks) vaginal delivery
- Adequate birth weight for gestational age (10-90 percentile)
- Infants with normal growth curve (10-90 percentile)
- Infants who were breastfeeding for at least 4 weeks, and at least half of the takes have been by breastfeeding.
- Infants aged 4 months (+/- 1 week) at the time of study inclusion no longer following breastfeeding, or mixed breastfeeding and if they are breast-feeding, no more than one shot a day.
Key exclusion criteria (10 listed)
- Infants who were born by cesarean section
- Infants born from preconception obese mothers
- Infants born from diabetic mothers or mothers with gestational diabetes
- Infants with a family history of celiac disease (parents or siblings)
- Infants who have had or have some type of allergic manifestation or allergic pathology
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 |
|---|---|---|
| Experimental cerealCereal containing probiotics, prebiotic fiber and low carbohydrates | Dietary supplement | Experimental Cereal |
| Conventional cerealGluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old) | Dietary supplement | Conventional cereal |
Primary outcome
Digestive tolerance
Time frame: From 4 to 12 months old
Infant Gastrointestinal Symptom Questionnaire (IGSQ) developed by Riley et al. to be completed by parents/guardians. It contains 13 ítems.For each item there are 5 possible answers in gradation 1 to 5 points and the result is the sum of all of them with minimum scores of 13 (maximum health status) and maximum of 65
11 secondary outcomes
Assessing infant feeding habits
Time frame: At 4, 5, 6, 9 and 12 months old
Infant microbiota study
Time frame: Stool sample collected at 4, 6 and 12 months old.
Assessment of intestinal health
Time frame: Stool sample collected at 4, 6 and 12 months old.
Assessment of immune-inflammatory response
Time frame: At 4, 6 and 12 months old.
Infant infection episodes
Time frame: At 4, 5, 6, 9 and 12 months old.
Assessment of infant growth: weight
Time frame: At 4, 5, 6, 9 and 12 months old.
Assessment of infant growth: lenght
Time frame: At 4, 5, 6, 9 and 12 months old.
Assessment of infant growth: cephalic perimeter
Time frame: At 4, 5, 6, 9 and 12 months old.
Evolution of body composition
Time frame: At 4, 5, 6, 9 and 12 months old
Medical history
Time frame: At 4 months old
Demographics
Time frame: At 4 months old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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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.
Cristina Campoy, Professor principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental cereal and Conventional cereal in people with Gastrointestinal Disorder and Immunologic Diseases in Children, run by Laboratorios Ordesa at 1 site in Spain.
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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roser De Castellar, MD (+34 902105243, RoserDeCastellar@ordesa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digestive tolerance (time frame: From 4 to 12 months old). 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 16 Dec 2020.