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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04021303
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 18, 2019
Ministerio de Ciencia e Innovación, Spain
Information provided by (Responsible Party):
Laboratorios Ordesa

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Disorder Immunologic Diseases in Children Dietary Supplement: Experimental cereal Dietary Supplement: Conventional cereal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Experimental Cereal
Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.
Dietary Supplement: Experimental cereal
Cereal containing probiotics, prebiotic fiber and low carbohydrates

Active Comparator: Conventional cereal
Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.
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)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Assessing infant feeding habits [ Time Frame: At 4, 5, 6, 9 and 12 months old ]
    Analysis of daily intake through a record of food consumption for 24 hours

  2. Infant microbiota study [ Time Frame: Stool sample collected at 4, 6 and 12 months old. ]
    Composition, diversity of microbiota. This procedure will be performed by studying samples of feces.

  3. Assessment of intestinal health [ Time Frame: Stool sample collected at 4, 6 and 12 months old. ]
    Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination

  4. Assessment of immune-inflammatory response [ Time Frame: At 4, 6 and 12 months old. ]
    Record of the IgA secreted in saliva

  5. Infant infection episodes [ Time Frame: At 4, 5, 6, 9 and 12 months old. ]
    Specific parent-reported infant symptoms of mild respiratory, gastrointestinal, skin and oropharyngeal infections. Parents will have a dairy to report all symptoms.

  6. Assessment of infant growth: weight [ Time Frame: At 4, 5, 6, 9 and 12 months old. ]
    Weight measurements in grams to report anthropometric measures

  7. Assessment of infant growth: lenght [ Time Frame: At 4, 5, 6, 9 and 12 months old. ]
    Lenght measurements in centimeters to report anthropometric measures

  8. Assessment of infant growth: cephalic perimeter [ Time Frame: At 4, 5, 6, 9 and 12 months old. ]
    Cephalic perimeter measurements in centimeters to report anthropometric measures

  9. Evolution of body composition [ Time Frame: At 4, 5, 6, 9 and 12 months old ]
    Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer)

  10. Medical history [ Time Frame: At 4 months old ]
    Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest

  11. Demographics [ Time Frame: At 4 months old ]
    Parents' age, parent education level, habits and parents lifestyle, home and social environment

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04021303

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Contact: Roser De Castellar, MD +34 902105243

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Facultad de Medicina
Granada, Spain, 18071
Sponsors and Collaborators
Laboratorios Ordesa
Ministerio de Ciencia e Innovación, Spain
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Principal Investigator: Cristina Campoy, Professor Universidad de Granada

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Responsible Party: Laboratorios Ordesa Identifier: NCT04021303     History of Changes
Other Study ID Numbers: PROBIO-TOLERA
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laboratorios Ordesa:
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Immune System Diseases