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

NCT07758933 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HIM/2026/013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

Diarrhoeal disease; immunocompromised

Outcome Measures

Primary Outcomes (11)

• Vomiting

  Occurrence of vomiting during the intervention period.

  28 days

• Bloating

  Occurrence of bloating during the intervention period

  28 days

• Abdominal pain

  Occurrence of abdominal pain during the intervention period

  28 days

• Constipation

  Occurrence of constipation during the intervention period

  28 days

• Diarrhoeal disease worsening

  Occurrence of diarrhoeal disease worsening during the intervention period

  28 days

• Secondary gastrointestinal infection

  Occurrence of secondary gastrointestinal infection during the intervention period

  28 days

• Secondary systemic infection or sepsis

  Occurrence of secondary systemic infection or sepsis during the intervention period

  28 days

• Self-limited allergic reaction

  Occurrence of self-limited allergic reaction during the intervention period

  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

  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

  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

  28 days

Other Outcomes (2)

• Time to diarrhoea cessation

  28 days

• Time to stool consistency improvement

  28 days

Study Arms (1)

Immunocompromised patients

EXPERIMENTAL

Immunocompromised patients with diarrhoeal disease

Dietary Supplement: Lactobacillus LB

Interventions

Lactobacillus LB DIETARY_SUPPLEMENT

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.

Immunocompromised patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients under 18 years of age.
• Patients under hospital care in Federico Gomez Children's Hospital of Mexico
• 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:
• Immunocompromised patients with diarrhoeal disease within the first 72 hours of initiation
• Immunocompromised patients with chronic diarrhoea (≥15 days of diarrhoea onset,
• Patients whose parents or guardians give consent to participate and patients who assent to participate (when applicable)

You may not qualify if:

• Non-viable oral or enteral administration of Lactobacillus LB postbiotic (Lactéol®).
• Bacteriemia or sepsis.
• Haemodynamic instability.
• Severe neurological disturbances.
• Clinical signs of severe dehydration (prolonged capillary refill time, positive skin fold test, abnormal respiratory pattern, or absence of tears).
• Known intolerance or allergy to intervention components (lactose, fructose, sucrose, silicic acid, banana artificial flavour, orange artificial flavour,).

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead
• DSM-Firmenich AG: collaborator
• Aequitas Medica: collaborator

Study Sites (1)

Hospital Infantil de Mexico Federico Gomez

Cuahutemoc, Mexico City, 06720, Mexico

Location

Related Publications (13)

• Simakachorn N, Pichaipat V, Rithipornpaisarn P, Kongkaew C, Tongpradit P, Varavithya W. Clinical evaluation of the addition of lyophilized, heat-killed Lactobacillus acidophilus LB to oral rehydration therapy in the treatment of acute diarrhea in children. J Pediatr Gastroenterol Nutr. 2000 Jan;30(1):68-72. doi: 10.1097/00005176-200001000-00020.

  PMID: 10630442 BACKGROUND

• Lievin-Le Moal V, Sarrazin-Davila LE, Servin AL. An experimental study and a randomized, double-blind, placebo-controlled clinical trial to evaluate the antisecretory activity of Lactobacillus acidophilus strain LB against nonrotavirus diarrhea. Pediatrics. 2007 Oct;120(4):e795-803. doi: 10.1542/peds.2006-2930. Epub 2007 Sep 3.

  PMID: 17768180 BACKGROUND

• Vinderola G, Sanders ME, Cunningham M, Hill C. Frequently asked questions about the ISAPP postbiotic definition. Front Microbiol. 2024 Jan 10;14:1324565. doi: 10.3389/fmicb.2023.1324565. eCollection 2023.

  PMID: 38268705 BACKGROUND

• Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4.

  PMID: 33948025 BACKGROUND

• Vazquez-Frias R, Vinderola G, Abreu Y Abreu AT, Angulo D, Giler-Parraga N, Ladino L, Ortiz C, Pereira S, Bustamante JP. Postbiotics in pediatric clinical practice: position paper from Special Group of Latin American Society of Pediatric Gastroenterology, Hepatology and Nutrition (LASPGHAN). Front Nutr. 2025 Dec 17;12:1716791. doi: 10.3389/fnut.2025.1716791. eCollection 2025.

  PMID: 41479668 BACKGROUND

• Levy M, Kolodziejczyk AA, Thaiss CA, Elinav E. Dysbiosis and the immune system. Nat Rev Immunol. 2017 Apr;17(4):219-232. doi: 10.1038/nri.2017.7. Epub 2017 Mar 6.

  PMID: 28260787 BACKGROUND

• Angarone M, Snydman DR; AST ID Community of Practice. Diagnosis and management of diarrhea in solid-organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019 Sep;33(9):e13550. doi: 10.1111/ctr.13550. Epub 2019 Apr 10.

  PMID: 30913334 BACKGROUND

• Meier JL. Viral Acute Gastroenteritis in Special Populations. Gastroenterol Clin North Am. 2021 Jun;50(2):305-322. doi: 10.1016/j.gtc.2021.02.003. Epub 2021 Apr 23.

  PMID: 34024443 BACKGROUND

• Shankar S, Rosenbaum J. Chronic diarrhoea in children: A practical algorithm-based approach. J Paediatr Child Health. 2020 Jul;56(7):1029-1038. doi: 10.1111/jpc.14986.

  PMID: 32725734 BACKGROUND

• Tripathi PR, Srivastava A. Approach to a Child with Chronic Diarrhea. Indian J Pediatr. 2024 May;91(5):472-480. doi: 10.1007/s12098-023-04587-9. Epub 2023 Jun 27.

  PMID: 37368219 BACKGROUND

• Guarino A, Ashkenazi S, Gendrel D, Lo Vecchio A, Shamir R, Szajewska H; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; European Society for Pediatric Infectious Diseases. European Society for Pediatric Gastroenterology, Hepatology, and Nutrition/European Society for Pediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: update 2014. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):132-52. doi: 10.1097/MPG.0000000000000375.

  PMID: 24739189 BACKGROUND

• George S, Aguilera X, Gallardo P, Farfan M, Lucero Y, Torres JP, Vidal R, O'Ryan M. Bacterial Gut Microbiota and Infections During Early Childhood. Front Microbiol. 2022 Jan 5;12:793050. doi: 10.3389/fmicb.2021.793050. eCollection 2021.

  PMID: 35069488 BACKGROUND

• GBD 2021 Diarrhoeal Diseases Collaborators. Global, regional, and national age-sex-specific burden of diarrhoeal diseases, their risk factors, and aetiologies, 1990-2021, for 204 countries and territories: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Infect Dis. 2025 May;25(5):519-536. doi: 10.1016/S1473-3099(24)00691-1. Epub 2024 Dec 18.

  PMID: 39708822 BACKGROUND

MeSH Terms

Conditions

Diarrhea

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo Vazquez-Frias

  Hospital Infantil de Mexico Federico Gomez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magali Reyes-Apodaca, Dr

CONTACT

+52 (55) 5228 9917; maghimfg@gmail.com

Edgar Ramirez-Ramirez, Dr

CONTACT

+52 (55) 9990 4315; edgar.ramirez@aequitasmedica.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Research

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 11, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)