Effect of Probiotics on Gut Microbiota During the Helicobacter Pylori Eradication

NCT05662514 | Unknown

• 1 other identifier: KYLL-202210-011
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Helicobacter pylori (H. pylori) is still infecting more than half of the population in many countries, although the prevalence is decreasing. As a main cause of chronic gastritis, peptic ulcer, and malignant gastric tumors, H. pylori places a heavy burden on developing countries and regions with high infection rate. In the last decade, the eradication rates of conventional regimens based on proton pump inhibitors (PPIs) plus antibiotics have been decreasing. Antibiotic resistance and decrease of drug compliance caused by adverse effects were the two main reasons for eradication failure. Moreover, H. pylori treatment causes dysbiosis of gut microbiota and increases the expression of antibiotic resistance gene. Therefore, eradication of H. pylori is facing a great challenge, and effective and safe methods are needed. To reduce adverse effects, improve drug compliance and increase eradication rates, certain probiotics were added to conventional regimens in several clinical studies. Probiotics were more or less shown to reduce adverse effects in the vast majority of clinical studies, but whether probiotics can improve the eradication rate of H. pylori remains controversial. Meanwhile, several studies focusing on the impact of probiotics on gut microbiota during H. pylori eradication have been published recently. Thus, we conducted a randomized, double-blind, placebo-controlled trial aiming to evaluate the effects of probiotics combining with 14-day bismuth quadruple therapy on H. pylori eradication.

Conditions

Helicobacter Pylori Infection; Gut Microbiota

Keywords

Helicobacter pylori; Gut microbiota; Probiotics

Outcome Measures

Primary Outcomes (1)

• Gut microbiota

  Stool samples were collected at wk0, wk2, and wk10. Patients were instructed to collect stool samples at the medical visit site by using disposable sterile feces collection tubes. Samples were stored at -80℃ after collection immediately. In this study, the influences of antibiotics and combination of probiotics on gut microbiota during H. pylori treatments were investigated using high-throughput sequencing of the 16S rRNA gene.

  Week 0, week 2 and week 10

Secondary Outcomes (2)

• Rate of adverse reactions

  Week 2 and week 10

• Patient compliance

  Week 10

Study Arms (2)

Probiotic group

EXPERIMENTAL

Esomeprazole 20 mg and bismuth 2g twice daily before meals, amoxicillin 1 g, and clarithromycin 500 mg twice daily after meals, probiotic once a day with one packet each time 2 hours after taking medicine above in the evening, for 2 weeks.

Dietary Supplement: Bifidobacterium animalis subsp. lactis BLa80

Placebo group

PLACEBO COMPARATOR

Esomeprazole 20 mg and bismuth 2g twice daily before meals, amoxicillin 1 g, and clarithromycin 500 mg twice daily after meals, placebo once a day with one packet each time 2 hours after taking medicine above in the evening, for 2 weeks.

Other: Placebo

Interventions

Bifidobacterium animalis subsp. lactis BLa80 DIETARY_SUPPLEMENT

Test product contain 3 × 109 colony-forming units \[CFU\] Bifidobacterium animalis subsp. lactis BLa80 strains, for each packet. Subjects ingested one packet (3 g/packet) of Test product per day (2 hours after taking antibiotics in the evening), for 14 days.

Probiotic group

Placebo OTHER

To maintain the blinding, patients in the control group received placebo included in identical packets. Control product per day (2 hours after taking antibiotics), for 14 days.

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-70.
• Patients with H. pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
• Patients who have did not receive H. pylori eradication treatment before.

You may not qualify if:

• Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
• Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
• Patients with active gastrointestinal bleeding.
• Patients with a history of upper gastrointestinal surgery.
• Patients allergic to treatment drugs.
• Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs which might influence gut microbiota within 3 months.
• Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse.
• Patients who are unwilling or incapable to provide informed consents.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Related Publications (4)

• Yang C, Liang L, Lv P, Liu L, Wang S, Wang Z, Chen Y. Effects of non-viable Lactobacillus reuteri combining with 14-day standard triple therapy on Helicobacter pylori eradication: A randomized double-blind placebo-controlled trial. Helicobacter. 2021 Dec;26(6):e12856. doi: 10.1111/hel.12856. Epub 2021 Oct 10.

  PMID: 34628695 BACKGROUND

• Yuan Z, Xiao S, Li S, Suo B, Wang Y, Meng L, Liu Z, Yin Z, Xue Y, Zhou L. The impact of Helicobacter pylori infection, eradication therapy, and probiotics intervention on gastric microbiota in young adults. Helicobacter. 2021 Dec;26(6):e12848. doi: 10.1111/hel.12848. Epub 2021 Aug 26.

  PMID: 34448282 BACKGROUND

• Nabavi-Rad A, Sadeghi A, Asadzadeh Aghdaei H, Yadegar A, Smith SM, Zali MR. The double-edged sword of probiotic supplementation on gut microbiota structure in Helicobacter pylori management. Gut Microbes. 2022 Jan-Dec;14(1):2108655. doi: 10.1080/19490976.2022.2108655.

  PMID: 35951774 BACKGROUND

• Guillemard E, Poirel M, Schafer F, Quinquis L, Rossoni C, Keicher C, Wagner F, Szajewska H, Barbut F, Derrien M, Malfertheiner P. A Randomised, Controlled Trial: Effect of a Multi-Strain Fermented Milk on the Gut Microbiota Recovery after Helicobacter pylori Therapy. Nutrients. 2021 Sep 11;13(9):3171. doi: 10.3390/nu13093171.

  PMID: 34579049 RESULT

Study Officials

• Tao Zhou, Dr

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Tao Zhou, Dr

CONTACT

18560086097; lyynqj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 22, 2022
• Study Start: February 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: February 9, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share