NCT04081415|Unknown
Longitudinal Study of the Intestinal, Cutaneous and Salivary Microbiota in Children With Food-induced Enterocolitis Syndrome (SEIPA)
SEIBIOTE
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SEIBIOTE
Sponsor study identifier
observational
25
1 country
1
Study Start
December 26, 2019
Actual (reported)Primary Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Food Protein-Induced Enterocolitis Syndrome (FPIES) is a non IgE-mediated allergy, presenting with vomiting, and may be complicated by hypovolemic shock. The pathophysiology of FPIES is not well characterized and there is no biological marker confirming the diagnosis or predicting recovery. Gut microbiota in IgE-mediated allergy is pro-inflammatory and the addition of pro- or prebiotics can accelerate healing. Microbiota of patients with FPIES have never been studied yet. The aim of this work is therefore to analyse longitudinally the gut microbiota of patients with FPIES, before and after healing, in order to predict the recovery from FPIES. The cutaneous and salivary microbiota will also be analysed at the same time, in order to look for a correlation between these three microbiota.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 24, 2019
Actual (reported)September 9, 2019
Actual (reported)December 26, 2019
Actual (reported)April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Gut microbiota
study of the diversity and composition of microbiota (rARN 16 S)
Between 1 and 4.5 years
Gut metabolites
Between 1 and 4.5 years
Saliva microbiota
Between 1 and 4.5 years
Skin microbiota
Between 1 and 4.5 years
Clinical description of the cohort
day 0 and between 1 and 4.5 years
Not yet healed children with FPIES
The recruited population of children will have an untreated FPIES, either recruitment between the diagnosis and the 1st OFC, or following an OFC failure. The cohort is followed in the Department of Pediatric Nutrition and Gastroenterology, Trousseau Hospital - APHP. The parents and the patients in age to do give their non-opposition to participate to the study. The included children of the study will be followed by their usual referent allergist, at the usual place of consultations without any particular modification related to this protocol of research on the microbiota, namely every 6 to 12 months.
Trousseau Hospital, Service : Nutrition et Gastroentérologie Pédiatrique
Paris, France
Stool The required volume is about 1g, or 1 mL per pot. The first sample will be lyophilized in the functional coprology laboratory of Prof. Kapel, and will be study at INRA for bacterial distribution and diversity by sequencing 16S ribosomal bacterial RNAs (16S rRNA) as well as the dosage of short chain fatty acids, such as butyrate. The second sample will allow the determination of protein in stool, such as fecal calprotectin, ECP, EDN. Saliva Collection of a volume of at least 250 μL, before and after the FPIES healing. Skin swab The cutaneous microbiota will be collected using 4 sterile cotton swabs in the ante-ulnar trough, back, nostril, and the plantar arch (according to Grice et al).Then the rRNA16s will be extracted, amplified and sequenced to study the richness and diversity of the microbiota. The fecal, cutaneous and salivary microbiota will be collected again 1 to 6 months after the success of the last OFC, during a follow-up consultation at the hospital.
Anais Lamoine, CCA
Assistance Publique - Hôpitaux de Paris
First Submitted
May 24, 2019
First Posted
September 9, 2019
Study Start
December 26, 2019
Actual (reported)Primary Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
April 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 3, 2021
Record last verified: 2021-07
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