Longitudinal Study of the Intestinal, Cutaneous and Salivary Microbiota in Children With Food-induced Enterocolitis Syndrome (SEIPA)

NCT04081415 | Unknown

• 1 other identifier: APHP190297
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

FPIES

Keywords

FPIES; microbiota; gut; stool; calprotectin saliva; skin

Outcome Measures

Primary Outcomes (1)

• Gut microbiota

  study of the diversity and composition of microbiota (rARN 16 S)

  Between 1 and 4.5 years

Secondary Outcomes (4)

• 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

Study Arms (1)

Group with FPIES

Not yet healed children with FPIES

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• patients aged from the first days of life to 18 years old
• confirmed FPIES

You may not qualify if:

• inflammatory bowel disease
• long term antibiotics
• immunodeficiency

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Trousseau Hospital, Service : Nutrition et Gastroentérologie Pédiatrique

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

Study Officials

• Anais Lamoine, CCA

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anais Lamoine, CCA

CONTACT

01 71 73 82 83; anais.lemoine@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: September 9, 2019
• Study Start: December 26, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)