Randomized, double-blind, placebo-controlled clinical trial of Lactobacillus reuteri LR09 or Lactobacillus acidophilus LA-10A for the improvement of Helicobacter pylori infection

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200066616

Enrollment

Unknown

Registered

2022-12-12

Start date

2022-12-13

Completion date

Unknown

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

Placebo:Placebo for 28 days

Probiotics( Lactobacillus reuteri LR09 ): Lactobacillus reuteri LR09 for 28days

Probiotics( Lactobacillus acidophilus LA-10A):Lactobacillus acidophilus LA-10A for 28days

Eligibility

Sex/Gender

All

Age

7 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 8-18 years old, excluding 18 years old; 2. No gender limit; 3. Positive for Helicobacter pylori within 12 months before enrollment by 13-C-urea breath test (UBT), rapid urease test, serum Hp antibody or histological examination; 4. Good compliance, able to comply with the requirements of clinical trials; 5. The subject or guardian has signed the informed consent form, basic situation questionnaire, dietary structure and living conditions questionnaire, and has committed to cooperate with the study throughout the trial period. 5. The subject or guardian has signed the informed consent form, basic information questionnaire, dietary structure and Life situation questionnaire and commit to cooperate with the study throughout the trial.

Exclusion criteria

Exclusion criteria: 1. Subjects treated with previous Helicobacter pylori; 2. Those who took antibiotics, proton pump inhibitors, bismuth preparations and certain traditional Chinese medicines with antibacterial effects in the 4 weeks before enrollment; 3. Those who have taken probiotics, prebiotics or synbiotics 2 weeks before enrollment; 4. Those who have a history of previous digestive surgery (except appendectomy, polypectomy and cholecystectomy); 5. Severe mental or nervous system abnormalities 6. Alcohol or drug abusers; 7. Those who cannot adhere to treatment and participate in other clinical studies; 8. Those who have participated in other clinical trials within 4 weeks before enrollment; 9. Those who are judged to be poor in compliance and are deemed unsuitable to participate in this clinical study after evaluation; 10. Relevant personnel of this clinical trial research.

Design outcomes

Primary

Measure	Time frame
capacity;Microbiota analysis;Gastrointestinal Symptom Score (GSRS);	—

Countries

China

Contacts

Public ContactXu Yihui

The First People's Hospital of Kunshan

932551223@qq.com+8651257519231

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026