Diarrhea
Conditions
Keywords
Diarrhoeal disease, immunocompromised
Brief 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.
Interventions
DIETARY_SUPPLEMENTLactobacillus 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.
Sponsors
Hospital Infantil de Mexico Federico Gomez
DSM-Firmenich AG
Aequitas Medica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Contacts
CONTACTMagali Reyes-Apodaca, Dr
CONTACTEdgar Ramirez-Ramirez, Dr
PRINCIPAL_INVESTIGATORRodrigo Vazquez-Frias
Hospital Infantil de Mexico Federico Gomez
Outcome results
None listed