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

NCT04021303 | Unknown

• 1 other identifier: PROBIO-TOLERA
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. These are products adapted to infant feeding since 4 Months.

Conditions

Gastrointestinal Disorder; Immunologic Diseases in Children

Keywords

Gluten; Probiotic; Prebiotic

Outcome Measures

Primary Outcomes (1)

• 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

  From 4 to 12 months old

Secondary Outcomes (11)

• Assessing infant feeding habits

  At 4, 5, 6, 9 and 12 months old

• Infant microbiota study

  Stool sample collected at 4, 6 and 12 months old.

• Assessment of intestinal health

  Stool sample collected at 4, 6 and 12 months old.

• Assessment of immune-inflammatory response

  At 4, 6 and 12 months old.

• Infant infection episodes

  At 4, 5, 6, 9 and 12 months old.

Study Arms (2)

Experimental Cereal

EXPERIMENTAL

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

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.

Dietary Supplement: Conventional cereal

Interventions

Experimental cereal DIETARY_SUPPLEMENT

Cereal containing probiotics, prebiotic fiber and low carbohydrates

Experimental Cereal

Conventional cereal DIETARY_SUPPLEMENT

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

Conventional cereal

Eligibility Criteria

• Age: 4 Months - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Availability to continue throughout the study period.
• Signature of informed consent by partents/guardians.

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Laboratorios Ordesa: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator

Study Sites (1)

Facultad de Medicina

Granada, 18071, Spain

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Cristina Campoy, Professor

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roser De Castellar, MD

CONTACT

+34 902105243; RoserDeCastellar@ordesa.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 16, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

ES (1)