Gastro-oesophageal Reflux Disease Trial, Recruiting NCT07148583 Sponsor: Haiphong University of Medicine and Pharmacy Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT07148583
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Infants aged 0 to 24 months old at the time of joining the trial
  • Infants who have been assessed by a clinician as having functional gut symptoms, such as colic, irritability, spitting up, constipation, or loose stools, and who a clinician considers suitable for the study
  • A parent or legal guardian is willing to sign a consent form and agrees to follow the study procedures, including completing questionnaires or diaries and providing samples if required
  • Caregivers agree not to use any other probiotic products during the study, unless the study team advises otherwise

Who may not be able to join:

  • Infants with major birth-related gut abnormalities or known long-term gut diseases that require ongoing prescription medication, such as Hirschsprung disease, inflammatory bowel disease, or short-bowel syndrome
  • Infants with a clinically unstable condition or a severe or serious illness that the study doctor believes could affect their safety or ability to take part
  • Infants with a known or suspected immune system disorder, or who are currently receiving treatment that suppresses the immune system
  • Infants with a known or suspected serious allergy or reaction to any ingredient in the study product
  • Infants who have taken antibiotics in the 14 days before the study starts, or who have used probiotic supplements in the 14 days before the study starts
  • Infants who have taken part in another clinical trial within the 30 days before joining, or who are enrolled in another trial during this study
  • Infants who have any other condition that, in the study doctor's judgement, would make them unsuitable for the study or make it harder to measure results accurately

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +84936685007

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Haiphong University of Medicine and Pharmacy
Registry
ClinicalTrials.gov
Start date
5 September 2025
Est. completion
30 April 2026

Where this trial is recruiting

🇻🇳 Vietnam

Primary endpoints

Change from Baseline in Infant Gastrointestinal Symptom Questionnaire (IGSQ) Total Score at Day 42; Stool Microbiome - Change in Alpha Diversity (Shannon, Chao1)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov