A Phase 1/2 interventional study of Lactobacillus LB in Diarrhea, sponsored by Hospital Infantil de Mexico Federico Gomez. Not yet recruiting at 1 site in Mexico. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Hospital Infantil de Mexico Federico Gomez · Phase 1/2, Interventional, and Treatment
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 30 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Hospital Infantil de Mexico Federico Gomez is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunocompromised patients with diarrhoeal disease
Dietary Supplement: 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.
Vomiting
Occurrence of vomiting during the intervention period.
Time frame: 28 days
Bloating
Occurrence of bloating during the intervention period
Time frame: 28 days
Abdominal pain
Occurrence of abdominal pain during the intervention period
Time frame: 28 days
Constipation
Occurrence of constipation during the intervention period
Time frame: 28 days
Diarrhoeal disease worsening
Occurrence of diarrhoeal disease worsening during the intervention period
Time frame: 28 days
Secondary gastrointestinal infection
Occurrence of secondary gastrointestinal infection during the intervention period
Time frame: 28 days
Secondary systemic infection or sepsis
Occurrence of secondary systemic infection or sepsis during the intervention period
Time frame: 28 days
Self-limited allergic reaction
Occurrence of self-limited allergic reaction during the intervention period
Time frame: 28 days
Non-anaphylactic allergic reaction that required medical treatment but no cessation of the intervention
Occurrence of non-anaphylactic allergic reaction that required medical treatment but no cessation of the intervention during the intervention period
Time frame: 28 days
Severe allergic reaction that required medical treatment and cessation of the intervention
Occurrence of severe allergic reaction that required medical treatment and cessation of the intervention during the intervention period
Time frame: 28 days
Other severe reactions that require medical treatment and cessation of the intervention
Occurrence of other severe reactions that require medical treatment and cessation of the intervention during the intervention period
Time frame: 28 days
Time to diarrhoea cessation
timeframe in which stool frequency was normalized
Time frame: 28 days
Time to stool consistency improvement
timeframe in which stool consistency improved by at least one category of Bristol stool scale
Time frame: 28 days
Plan to share: No — Patient data will not be shared due to privacy protection policies
Start is estimated for Jul 2026; primary completion for Nov 2026, 4 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hospital Infantil de Mexico Federico Gomez