Lactobacillus LB: In addition to the standard rehydration protocol and nutritional support, Patients will receive a dose of 2x10\^10 bacterial bodies of Lactobacillus LB (Lactéol®) equivalent to one sachet of the commercially available product administered orally or enterally twice daily (every 12 hours) during 14-28 days.
Study summary
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 (\<72 hours of onset) and for 28 days for patients with chronic diarrhoea (≥15 days). Patients will continue follow-up while receiving treatment in hospital, whereas patients who are discharged during the treatment period will continue follow-up via phone calls once weekly and a final evaluation of outcome variables in outpatient clinic at the end of the intervention. Data regarding adverse events, as well as the stop of diarrhoea (\<3 bowel movements in 24 hours or return to habitual bowel movement frequency) and improvement in stool consistency (at least one point decrease in Bristol Stool Scale) will be collected in every evaluation. Afterwards, the presence or absence of adverse events will be established with a binomial test. As efficacy evaluation is not the main objective of the study, efficacy will be assessed as exploratory variables as presence or absence of efficacy endpoints with the binomial test. If feasible, results may be stratified according to nutritional status, time of onset of diarrhoea, and treatment compliance.
Eligibility
Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Vomiting — 28 days Occurrence of vomiting during the intervention period.
Bloating — 28 days Occurrence of bloating during the intervention period
Abdominal pain — 28 days Occurrence of abdominal pain during the intervention period
Constipation — 28 days Occurrence of constipation during the intervention period
Diarrhoeal disease worsening — 28 days Occurrence of diarrhoeal disease worsening during the intervention period
Secondary gastrointestinal infection — 28 days Occurrence of secondary gastrointestinal infection during the intervention period
Secondary systemic infection or sepsis — 28 days Occurrence of secondary systemic infection or sepsis during the intervention period
Self-limited allergic reaction — 28 days Occurrence of self-limited allergic reaction during the intervention period
Non-anaphylactic allergic reaction that required medical treatment but no cessation of the intervention — 28 days Occurrence of non-anaphylactic allergic reaction that required medical treatment but no cessation of the intervention during the intervention period
Severe allergic reaction that required medical treatment and cessation of the intervention — 28 days Occurrence of severe allergic reaction that required medical treatment and cessation of the intervention during the intervention period
Other severe reactions that require medical treatment and cessation of the intervention — 28 days Occurrence of other severe reactions that require medical treatment and cessation of the intervention during the intervention period
Trial sites (1)
Facility
City
Region
Status
Hospital Infantil de Mexico Federico Gomez
Cuahutemoc
Mexico City
More Hospital Infantil de Mexico Federico Gomez trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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