MedDataX Logo

Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response

NCT ID: NCT04021303

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Disorder Immunologic Diseases in Children

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Gluten Probiotic Prebiotic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Cereal

Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.

Group Type EXPERIMENTAL

Experimental cereal

Intervention Type DIETARY_SUPPLEMENT

Cereal containing probiotics, prebiotic fiber and low carbohydrates

Conventional cereal

Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.

Group Type ACTIVE_COMPARATOR

Conventional cereal

Intervention Type DIETARY_SUPPLEMENT

Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental cereal

Cereal containing probiotics, prebiotic fiber and low carbohydrates

Intervention Type DIETARY_SUPPLEMENT

Conventional cereal

Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
* 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)
Minimum Eligible Age

4 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

Sponsor Role collaborator

Laboratorios Ordesa

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cristina Campoy, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Facultad de Medicina

Granada, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Roser De Castellar, MD

Role: CONTACT

Phone: +34 902105243

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cristina Campoy, Professor

Role: primary

Angela Muñoz, PHd Student

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROBIO-TOLERA

Identifier Type: -

Identifier Source: org_study_id