Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-01-01 @ 6:08 PM
Study NCT ID:
NCT04021303
Status:
UNKNOWN
Last Update Posted:
2020-12-16
First Post:
2019-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Digestive tolerance', 'timeFrame': 'From 4 to 12 months old', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Assessing infant feeding habits', 'timeFrame': 'At 4, 5, 6, 9 and 12 months old', 'description': 'Analysis of daily intake through a record of food consumption for 24 hours'}, {'measure': 'Infant microbiota study', 'timeFrame': 'Stool sample collected at 4, 6 and 12 months old.', 'description': 'Composition, diversity of microbiota. This procedure will be performed by studying samples of feces.'}, {'measure': 'Assessment of intestinal health', 'timeFrame': 'Stool sample collected at 4, 6 and 12 months old.', 'description': 'Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination'}, {'measure': 'Assessment of immune-inflammatory response', 'timeFrame': 'At 4, 6 and 12 months old.', 'description': 'Record of the IgA secreted in saliva'}, {'measure': 'Infant infection episodes', 'timeFrame': 'At 4, 5, 6, 9 and 12 months old.', 'description': 'Specific parent-reported infant symptoms of mild respiratory, gastrointestinal, skin and oropharyngeal infections. Parents will have a dairy to report all symptoms.'}, {'measure': 'Assessment of infant growth: weight', 'timeFrame': 'At 4, 5, 6, 9 and 12 months old.', 'description': 'Weight measurements in grams to report anthropometric measures'}, {'measure': 'Assessment of infant growth: lenght', 'timeFrame': 'At 4, 5, 6, 9 and 12 months old.', 'description': 'Lenght measurements in centimeters to report anthropometric measures'}, {'measure': 'Assessment of infant growth: cephalic perimeter', 'timeFrame': 'At 4, 5, 6, 9 and 12 months old.', 'description': 'Cephalic perimeter measurements in centimeters to report anthropometric measures'}, {'measure': 'Evolution of body composition', 'timeFrame': 'At 4, 5, 6, 9 and 12 months old', 'description': 'Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer)'}, {'measure': 'Medical history', 'timeFrame': 'At 4 months old', 'description': 'Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest'}, {'measure': 'Demographics', 'timeFrame': 'At 4 months old', 'description': "Parents' age, parent education level, habits and parents lifestyle, home and social environment"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gluten', 'Probiotic', 'Prebiotic'], 'conditions': ['Gastrointestinal Disorder', 'Immunologic Diseases in Children']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'minimumAge': '4 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy term infants (\\>37 weeks) vaginal delivery\n* Adequate birth weight for gestational age (10-90 percentile)\n* Infants with normal growth curve (10-90 percentile)\n* Infants who were breastfeeding for at least 4 weeks, and at least half of the takes have been by breastfeeding.\n* 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.\n* Availability to continue throughout the study period.\n* Signature of informed consent by partents/guardians.\n\nExclusion Criteria:\n\n* Infants who were born by cesarean section\n* Infants born from preconception obese mothers\n* Infants born from diabetic mothers or mothers with gestational diabetes\n* Infants with a family history of celiac disease (parents or siblings)\n* Infants who have had or have some type of allergic manifestation or allergic pathology\n* Infants who have needed antibiotic treatment or have received some type of probiotic (the week before inclusion)\n* Infants with malformations, diseases or conditions and physical disabilities that cause changes in growth and/or nutritional status\n* Infants diagnosed with any immune system-related disease (primary immunodeficiency)\n* Infants with a known allergy and/or intolerance to cow's milk protein\n* Parents' inability to follow study (at the discretion of the researcher)"}, 'identificationModule': {'nctId': 'NCT04021303', 'acronym': 'PROBIOTOLERA', 'briefTitle': 'Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Ordesa'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'PROBIO-TOLERA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Cereal', 'description': 'Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.', 'interventionNames': ['Dietary Supplement: Experimental cereal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional cereal', 'description': 'Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.', 'interventionNames': ['Dietary Supplement: Conventional cereal']}], 'interventions': [{'name': 'Experimental cereal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cereal containing probiotics, prebiotic fiber and low carbohydrates', 'armGroupLabels': ['Experimental Cereal']}, {'name': 'Conventional cereal', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)', 'armGroupLabels': ['Conventional cereal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cristina Campoy, Professor', 'role': 'CONTACT', 'email': 'ccampoy@ugr.es', 'phone': '607631601'}, {'name': 'Angela Muñoz, PHd Student', 'role': 'CONTACT', 'email': 'angela.munozma@gmail.com', 'phone': '664090546'}], 'facility': 'Facultad de Medicina', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'Roser De Castellar, MD', 'role': 'CONTACT', 'email': 'RoserDeCastellar@ordesa.es', 'phone': '+34 902105243'}], 'overallOfficials': [{'name': 'Cristina Campoy, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Ordesa', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ministerio de Ciencia e Innovación, Spain', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}