Whole Grain, Gluten-containing Cereal and PROBIOtics to Evaluate Digestive TOLERAance and Immuno-inflammatory Response (PROBIOTOLERA)
14. desember 2020 oppdatert 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
172
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Granada, Spania, 18071
- Rekruttering
- Facultad de Medicina
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Ta kontakt med:
- Cristina Campoy, Professor
- Telefonnummer: 607631601
- E-post: ccampoy@ugr.es
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Ta kontakt med:
- Angela Muñoz, PHd Student
- Telefonnummer: 664090546
- E-post: angela.munozma@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 måneder til 4 måneder (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Digestive tolerance
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Assessing infant feeding habits
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Cristina Campoy, Professor, Universidad de Granada
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. september 2019
Primær fullføring (Forventet)
1. juni 2021
Studiet fullført (Forventet)
1. juni 2021
Datoer for studieregistrering
Først innsendt
5. juli 2019
Først innsendt som oppfylte QC-kriteriene
15. juli 2019
Først lagt ut (Faktiske)
16. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. desember 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. desember 2020
Sist bekreftet
1. desember 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PROBIO-TOLERA
Legemiddel- og utstyrsinformasjon, studiedokumenter
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