Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response (PROBIOTOLERA)
14 december 2020 uppdaterad av: Laboratorios Ordesa
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.
Studieöversikt
Status
Okänd
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
172
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Granada, Spanien, 18071
- Rekrytering
- Facultad de Medicina
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Kontakt:
- Cristina Campoy, Professor
- Telefonnummer: 607631601
- E-post: ccampoy@ugr.es
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Kontakt:
- Angela Muñoz, PHd Student
- Telefonnummer: 664090546
- E-post: angela.munozma@gmail.com
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
4 månader till 4 månader (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Experimental Cereal
Experimental cereal with probiotics, prebiotic fiber and low carbohydrates through all the duration of the study.
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Cereal containing probiotics, prebiotic fiber and low carbohydrates
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Aktiv komparator: Conventional cereal
Conventional gluten free cereal between 4 and 6 months old, and conventional gluten cereal between 7 and 12 months old.
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Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Digestive tolerance
Tidsram: From 4 to 12 months old
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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
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From 4 to 12 months old
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Assessing infant feeding habits
Tidsram: At 4, 5, 6, 9 and 12 months old
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Analysis of daily intake through a record of food consumption for 24 hours
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At 4, 5, 6, 9 and 12 months old
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Infant microbiota study
Tidsram: Stool sample collected at 4, 6 and 12 months old.
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Composition, diversity of microbiota.
This procedure will be performed by studying samples of feces.
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Stool sample collected at 4, 6 and 12 months old.
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Assessment of intestinal health
Tidsram: Stool sample collected at 4, 6 and 12 months old.
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Fecal microbiota profile (fecal pH, butyrate, propionate and acetate) determination
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Stool sample collected at 4, 6 and 12 months old.
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Assessment of immune-inflammatory response
Tidsram: At 4, 6 and 12 months old.
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Record of the IgA secreted in saliva
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At 4, 6 and 12 months old.
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Infant infection episodes
Tidsram: At 4, 5, 6, 9 and 12 months old.
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Specific parent-reported infant symptoms of mild respiratory, gastrointestinal, skin and oropharyngeal infections.
Parents will have a dairy to report all symptoms.
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At 4, 5, 6, 9 and 12 months old.
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Assessment of infant growth: weight
Tidsram: At 4, 5, 6, 9 and 12 months old.
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Weight measurements in grams to report anthropometric measures
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At 4, 5, 6, 9 and 12 months old.
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Assessment of infant growth: lenght
Tidsram: At 4, 5, 6, 9 and 12 months old.
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Lenght measurements in centimeters to report anthropometric measures
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At 4, 5, 6, 9 and 12 months old.
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Assessment of infant growth: cephalic perimeter
Tidsram: At 4, 5, 6, 9 and 12 months old.
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Cephalic perimeter measurements in centimeters to report anthropometric measures
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At 4, 5, 6, 9 and 12 months old.
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Evolution of body composition
Tidsram: At 4, 5, 6, 9 and 12 months old
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Anthropometric measures (brachial perimeter (mm), trichital skin folds and sub-scapular (mm) with compass lipometer)
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At 4, 5, 6, 9 and 12 months old
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Medical history
Tidsram: At 4 months old
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Register of: gestational age, anthropometric measures at birth, lactation data and clinical history of interest
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At 4 months old
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Demographics
Tidsram: At 4 months old
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Parents' age, parent education level, habits and parents lifestyle, home and social environment
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At 4 months old
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Cristina Campoy, Professor, Universidad de Granada
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 september 2019
Primärt slutförande (Förväntat)
1 juni 2021
Avslutad studie (Förväntat)
1 juni 2021
Studieregistreringsdatum
Först inskickad
5 juli 2019
Först inskickad som uppfyllde QC-kriterierna
15 juli 2019
Första postat (Faktisk)
16 juli 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 december 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 december 2020
Senast verifierad
1 december 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PROBIO-TOLERA
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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