DiarrheaPhase 1/2NCT07758933
Safety of Lactobacillus LB Postbiotic in Immunocompromised Paediatric Patients With Diarrhoeal Disease
A Phase 1/2 study testing Lactobacillus LB in people with Diarrhea, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- Lactobacillus LB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 13 Jul 2026to 15 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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,).
- Any exclusion criteria as per investigator assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Hospital Infantil de Mexico Federico Gomez
Cuahutemoc, Mexico City, 06720
About this study
Official title: Prospective Study on the Safety of the Postbiotic Lactobacillus LB (Lactéol®) in Immuocompromised Pediatric Patients With Diarrhoeal Disease Treated at the Federico Gómez Children's Hospital of Mexico.
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
- Being tested
- Lactobacillus LB
- Keywords
- Diarrhoeal disease, immunocompromised
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus LBDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Immunocompromised patients | Experimental | Immunocompromised patients with diarrhoeal disease Receives: Dietary Supplement: Lactobacillus LB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vomiting
Occurrence of vomiting during the intervention period.
Measured: 28 days
Bloating
Occurrence of bloating during the intervention period
Measured: 28 days
Abdominal pain
Occurrence of abdominal pain during the intervention period
Measured: 28 days
Constipation
Occurrence of constipation during the intervention period
Measured: 28 days
Diarrhoeal disease worsening
Occurrence of diarrhoeal disease worsening during the intervention period
Measured: 28 days
Secondary gastrointestinal infection
Occurrence of secondary gastrointestinal infection during the intervention period
Measured: 28 days
Secondary systemic infection or sepsis
Occurrence of secondary systemic infection or sepsis during the intervention period
Measured: 28 days
Self-limited allergic reaction
Occurrence of self-limited allergic reaction during the intervention period
Measured: 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
Measured: 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
Measured: 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start13 Jul 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, Aequitas Medica
- Responsible party
- Principal investigator, Rodrigo Vazquez-Frias, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Rodrigo Vazquez-Frias, Principal investigator, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758933
- Sponsor's protocol ID
- HIM/2026/013
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will not be shared due to privacy protection policies
Publications
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.
PubMed 10630442Lievin-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.
PubMed 17768180Vinderola 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.
PubMed 38268705Salminen 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.
PubMed 33948025Vazquez-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.
PubMed 41479668Levy 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.
PubMed 28260787Angarone 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.
PubMed 30913334Meier 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.
PubMed 34024443Shankar 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.
PubMed 32725734Tripathi 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.
PubMed 37368219Guarino 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.
PubMed 24739189George 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.
PubMed 35069488GBD 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.
PubMed 39708822
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Safety of the Postbiotic Lactobacillus LB (Lactéol®) in Immuocompromised Pediatric Patients With Diarrhoeal Disease Treated at the Federico Gómez Children's Hospital of Mexico.
- ClinicalTrials.gov ID
- NCT07758933
- Acronym / sponsor ID
- HIM/2026/013
- Conditions
- Diarrhea
- Keywords
- Diarrhoeal disease, immunocompromised
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, Aequitas Medica
- Study start
- 13 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunocompromised patients | Experimental | Dietary Supplement: Lactobacillus LBImmunocompromised patients with diarrhoeal disease |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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:
- Patients whose parents or guardians give consent to participate and patients who assent to participate (when applicable)
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus LBIn 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. | Dietary supplement | Immunocompromised patients |
Primary outcome
Vomiting
Time frame: 28 days
Occurrence of vomiting during the intervention period.
Bloating
Time frame: 28 days
Occurrence of bloating during the intervention period
Abdominal pain
Time frame: 28 days
Occurrence of abdominal pain during the intervention period
Constipation
Time frame: 28 days
Occurrence of constipation during the intervention period
Diarrhoeal disease worsening
Time frame: 28 days
Occurrence of diarrhoeal disease worsening during the intervention period
Secondary gastrointestinal infection
Time frame: 28 days
Occurrence of secondary gastrointestinal infection during the intervention period
Secondary systemic infection or sepsis
Time frame: 28 days
Occurrence of secondary systemic infection or sepsis during the intervention period
Self-limited allergic reaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days
Occurrence of other severe reactions that require medical treatment and cessation of the intervention during the intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 10630442Simakachorn 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.
- Background: PubMed 17768180Lievin-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.
- Background: PubMed 38268705Vinderola 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.
- Background: PubMed 33948025Salminen 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.
- Background: PubMed 41479668Vazquez-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.
- Background: PubMed 28260787Levy 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.
- Background: PubMed 30913334Angarone 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.
- Background: PubMed 34024443Meier 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.
- Background: PubMed 32725734Shankar 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.
- Background: PubMed 37368219Tripathi 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.
- Background: PubMed 24739189Guarino 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.
- Background: PubMed 35069488George 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.
- Individual participant dataSharing planned: No. Patient data will not be shared due to privacy protection policies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodrigo Vazquez-Frias principal investigator
Hospital Infantil de Mexico Federico Gomez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactobacillus LB in people with Diarrhea, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magali Reyes-Apodaca, Dr (+52 (55) 5228 9917, maghimfg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vomiting (time frame: 28 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07758933, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.