Microbiome and Volatile Organic Compounds in Patients With CDH

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03787160
• Date of registration: 10/07/2018
• Prospective Registration: No
• Primary sponsor: Medical University of Graz
• Public title: Microbiome and Volatile Organic Compounds in Patients With CDH CDHVOCS
• Scientific title: Determining the Effect of Probiotics on Microbiome and Volatile Organic Compounds in Patients After Surgical Repair of Congenital Diaphragmatic Hernia
• Date of first enrolment: March 22, 2018
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03787160
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Ernst Eber, MD
• Affiliation: Department of Pediatric and Adolescent Medicine, Medical University of Graz

• Name: Till Holger, MD
• Affiliation: Department of Pediatric and Adolescent Surgery, Medical University of Graz

• Name: Gert Warncke, MD
• Affiliation: Department of Pediatric and Adolescent Surgery, Medical University of Graz

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age from 6-16 years

- Age 0-6 months at time of CDH-OP (except control group)

- reliable diagnosis of congenital diaphragmatic hernia (except control group)

- surgical occlusion with patch (except control group)

- surgical occlusion without patch (except control group)

- given approval

Exclusion Criteria:

- chronic pulmonary diseases

- Infection within 4 weeks before the test date

- unaccepted consent



Age minimum: 6 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Congenital Diaphragmatic Hernia

Intervention(s)

Diagnostic Test: Fecal microbiome probiotic

Diagnostic Test: initial pulmonary microbiome

Diagnostic Test: initial fecal microbiome

Diagnostic Test: VOC probiotic

Diagnostic Test: initial VOC

Diagnostic Test: Pulmonary microbiome probiotic

Dietary Supplement: Probiotic treatment

Diagnostic Test: Functional residual capacity

Diagnostic Test: Maximum oxygen uptake

Primary Outcome(s)

Analysis of the cardiopulmonary capacity: Body fat of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Maximal oxygen uptake of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Oxygen uptake of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Resting ECG of CDH group versus control group. [Time Frame: 12 months]

Analysis of the lung function: Forced expiratory volume in one second (FEV1) measured with spirometry of CDH group versus control group. [Time Frame: 12 months]

Analysis of the lung function: Lung clearance index (LCI) is derived from multiple breath washout tests of CDH group versus control group. [Time Frame: 12 months]

Analysis of VOCs in the respiratory air by needle-trap microextraction (NTME) and stool by solid phase microextraction (SPME) of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Aerobic performance of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Breathing reserve of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Ventilation of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Body height of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Body weight of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Oxygen pulse of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Body mass index (BMI) of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Muscle mass of CDH group versus control group. [Time Frame: 12 months]

Analysis of the pulmonary microbiome in the sputum of CDH group versus control group. [Time Frame: 12 months]

Analysis of the cardiopulmonary capacity: Systolic and diastolic blood pressures of CDH group versus control group. [Time Frame: 12 months]

Secondary Outcome(s)

Analysis of the lung function: Forced expiratory volume (FEV1). [Time Frame: 12 months]

Alterations of VOCs in the respiratory air after probiotic treatment for a period of 3 months in patients with CDH. [Time Frame: 12 months]

Analysis of the lung function: Forced expiratory flow (FEF25-75). [Time Frame: 12 months]

Analysis of the lung function: Functional residual capacity (FRC). [Time Frame: 12 months]

Analysis of the lung function: Max. expiratory flow (MEF25). [Time Frame: 12 months]

Analysis of the lung function: Through body plethysmography acquired FRC (RC(pleth)). [Time Frame: 12 months]

Alterations of pulmonary microbiome after probiotic treatment for a period of 3 months in patients with CDH. [Time Frame: 12 months]

Analysis of the lung function: Max. expiratory flow (MMEF). [Time Frame: 12 months]

Analysis of the lung function: Through "multiple breath washout" acquired FRC (RC(MBW)). [Time Frame: 12 months]

Analysis of the lung function: Forced expiratory flow (FEF25). [Time Frame: 12 months]

Analysis of the lung function: Forced vital capacity (FVC). [Time Frame: 12 months]

Analysis of the lung function: Max. expiratory flow (MEF50). [Time Frame: 12 months]

Analysis of the lung function: Tiffeneau-Index (FEV1%FVC). [Time Frame: 12 months]

Analysis of the lung function: Forced expiratory flow (FEF50). [Time Frame: 12 months]

Analysis of the lung function: Intrathoracic gasvolume (ITGV). [Time Frame: 12 months]

Secondary ID(s)

28-528 ex 15/16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Rostock