Reconstituting the microbiome after pneumonia.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Age >= 18 y
• Clinical suspicion of a new episode of acute respiratory tract infection for
which treatment with antibiotics is deemed necessary.
• Presence of two or more diagnostic clinical criteria:
o Cough
o Production of purulent sputum or a change in the character of sputum
o Temperature >38°C or <36.1°C
o Auscultatory findings consistent with pneumonia, including rales, evidence of
pulmonary consolidation (dullness on
o percussion, bronchial breath sounds, or egophony), or both
o Leukocytosis (>10×10^9 white cells per liter or >15% bands)
o C-reactive protein level more than 3 times the upper limit of the normal range
o Dyspnoea, tachypnea, or hypoxemia

Exclusion Criteria

No informed consent is provided by patient or its legal representative
Admission to Intensive Care facilities in the current episode
Presence of enterobacteriaceae or staphylococcus aureus bacteraemia
Suspicion/diagnosis of aspiration pneumonia
More than 7 days use of probiotics or antibiotics within the last 2 months
Patients diagnosed with chronic bowel disease and/or colostomy.
Patient is enrolled in an interventional clinical study of an anti-infective or
immunomodulatory therapy.
Pregnancy.
Parenteral feeding or enteral tube feeding.
Patients who are readmitted to the hospital during the 90-day intervention
period will terminate the intervention. Follow-up will be continued without
further sampling.
Patients who are prescribed new antibiotic treatment by the general
practitioner during the 90 day intervention period will terminate the
intervention. Follow-up will be continued without further sampling.
Patients who are immunocompromised due to active chemotherapy, uncontrolled HIV
infection, stem-cell transplantation, haematological malignancies or high-dose
immunosuppressive drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Difference in microbiome diversity and composition between groups, analysed<br /><br>by deep 16s RNA sequencing. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Incidence of adverse events.<br /><br>2. Difference in mean cytokine response levels between groups.<br /><br>3. Incidence and duration of antibiotic-associated diarrhoea, based on<br /><br>Bristol-stool scale scores.<br /><br>4. To link cytokine response levels to microbiome composition and clinical<br /><br>endpoints.</p><br>