Microbiome and Volatile Organic Compounds in Patients With CDH

Summary

Despite improved prenatal diagnostics and therapeutic possibilities, congenital diaphragmatic hernia (CDH) represents a cross-disciplinary challenge. With an incidence of 1:2000-1:5000, it is a common disease that effects centres of paediatrics and juvenile medicine. The etiology is still unclear. Patients with this diagnosis are usually affected by other comorbities such as failure to thrive, gastroesophageal reflux, funnel chest, etc. Depending on the extent of CDH, a more or less pronounced lung hypoplasia with functional impairment occurs. The health-relevant importance of the human microbiome is increasingly evident. While it was previously particularly associated with the gastrointestinal tract, other systems such as the pulmonary microbiome have become the focus of scientific interest.

Research into changes in the microbiome and volatile organic compounds (VOCs) could provide new insights into the underlying mechanisms and therapeutic measures of this disease.

Conditions

• Congenital Diaphragmatic Hernia

Interventions

DIAGNOSTIC_TEST

initial VOC

Difference in VOC profile between patients with CDH and healthy controls (2 samples per patient will be obtained after obtaining informed consent).

DIAGNOSTIC_TEST

initial fecal microbiome

Difference of alpha and beta diversity and relative fecal bacterial abundance between patients with CDH and healthy controls (1 stool sample will be taken per patient after obtaining informed consent)

DIAGNOSTIC_TEST

initial pulmonary microbiome

Difference of alpha and beta diversity and relative pulmonary bacterial abundance between patients with CDH and healthy controls (1 deep induced sputum sample will be taken per patient after obtaining informed consent)

DIAGNOSTIC_TEST

Maximum oxygen uptake

Comparison of the maximum oxygen uptake (corrected for body weight and gender) as determined by bicycle spiroergometry between patients with CDH and healthy controls

DIAGNOSTIC_TEST

Functional residual capacity

FRC will be determined by spirometry, bodyplethysmography and N2-breath wash out method. FRC will be compared between patients after CDH and healthy controls.

DIETARY_SUPPLEMENT

Probiotic treatment

CDH patients will receive OmniBiotic 6(R) (Allergosan, Graz, Austria) probiotic supplementation 1 sachet daily for 3 months.

DIAGNOSTIC_TEST

VOC probiotic

Determination of the VOC profile 3 months after discontinuing probiotic treatment. Comparison to the profiles before the treatment.

DIAGNOSTIC_TEST

Fecal microbiome probiotic

Determination of the fecal microbiome from 1 sample per patient (alpha and beta diversity, relative bacterial abundance at the genus level) 3 months after discontinuing probiotic treatment. Comparison to the profiles before the treatment.

DIAGNOSTIC_TEST

Pulmonary microbiome probiotic

Determination of the fecal microbiome from 1 deep induced sputum sample per patient (alpha and beta diversity, relative bacterial abundance at the genus level) 3 months after discontinuing probiotic treatment. Comparison to the profiles before the treatment.

Sponsors & Collaborators

• University of Rostock

  collaborator OTHER

• Medical University of Graz

  lead OTHER

Principal Investigators

• Till Holger, MD · Department of Pediatric and Adolescent Surgery, Medical University of Graz

• Ernst Eber, MD · Department of Pediatric and Adolescent Medicine, Medical University of Graz

• Gert Warncke, MD · Department of Pediatric and Adolescent Surgery, Medical University of Graz

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-22

Primary Completion

2019-10-01

Completion

2019-10-01

Countries

• Austria

Study Locations