Microbiome and Volatile Organic Compounds in Patients With CDH

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 22, 2018

Primary Completion Date

October 1, 2019

Study Completion Date

October 1, 2019

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.

Trial Locations (1)

8036

Department of Department of Pediatric and Adolescent Surgery, Medical University of Graz, Graz

All Listed Sponsors
collaborator

University of Rostock

OTHER

lead

Medical University of Graz

OTHER

NCT03787160 - Microbiome and Volatile Organic Compounds in Patients With CDH | Biotech Hunter | Biotech Hunter