Safety of Lactobacillus LB Postbiotic in Immunocompromised Paediatric Patients With Diarrhoeal Disease

This prospective, interventional, single-center, open-label, phase 1 clinical trial to assess the safety of the Postbiotic Lactobacillus LB in immunocompromised paediatric patients with diarrhoeal disease will be performed at Federico Gomez Children's Hospital of México. Patients will be screened by investigators from hospitalized patients. For eligible children, parents will be invited to participate in the study and provide written consent, in patients of age 8 years and older, informed assent will also be required. Once enrolled, patients' demographic and stratification information will be obtained from the clinical record when applicable, if not, it will be directly collected by the investigator. Patients who have immunocompromise, as per investigator assessment, irrespective of the cause, will receive Lactobacillus LB (Lactéol®) sachets twice daily for 14 days for patients with acute diarrhoeal disease (\

Inclusion Criteria: 1. Patients under 18 years of age. 2. Patients under hospital care in Federico Gomez Children's Hospital of Mexico 3. Patients with diarrhoea (three or more loose or liquid stools in a 24 hour period, Bristol Stool Scale 5, 6 or 7) and either of two conditions: 1. Immunocompromised patients with diarrhoeal disease within the first 72 hours of initiation 2. Immunocompromised patients with chronic diarrhoea (≥15 days of diarrhoea onset, 4. Patients whose parents or guardians give consent to participate and patients who assent to participate (when applicable) Exclusion Criteria: 1. Non-viable oral or enteral administration of Lactobacillus LB postbiotic (Lactéol®). 2. Bacteriemia or sepsis. 3. Haemodynamic instability. 4. Severe neurological disturbances. 5. Clinical signs of severe dehydration (prolonged capillary refill time, positive skin fold test, abnormal respiratory pattern, or absence of tears). 6. Known intolerance or allergy to intervention components (lactose, fructose, sucrose, silicic acid, banana artificial flavour, orange artificial flavour,). 7. Any exclusion criteria as per investigator assessment.