Probiotics in the Reduction of Adverse Effects and Dysbiosis of H. Pylori Eradication

NCT03722433 | Unknown Phase 4

• 1 other identifier: 201706036MIPA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to assess the effect of probiotic supplementation with Vigiis 101-LAB during H. pylori eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse effects in the first line therapy in the two treatment groups

  At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events and compliance at the end of treatment. Patients with low compliance as defined by taking less than 80% of the pills and those lost to follow up will be excluded from the per-protocol analysis.

  8 weeks

Secondary Outcomes (1)

• Eradication rates in the first line treatment in the two treatment groups

  6 weeks

Study Arms (2)

probiotic plus 14-day sequential therapy

EXPERIMENTAL

D1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days

Drug: Vigiis 101-LAB and sequential therapy

placebo plus 14-day sequential therapy

PLACEBO COMPARATOR

D1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days

Drug: Placebo and sequential therapy

Interventions

Vigiis 101-LAB and sequential therapy DRUG

Vigiis 101-LAB is the probiotic containing Lactobacillus paracasei subsp. Paracasei, which is the isolate from Taiwanese by Prof. Pan. This strain is resistant to gastric acid and bile acid. Therefore, its survival rate in the gastrointestinal tract could be as high as 95%. Previous studies showed that Vigiis 101-LAB can modulate the gut microbiota, with 10% increase in Bifidobacterium species and 20% reduction in Clostridium difficile.

probiotic plus 14-day sequential therapy

Placebo and sequential therapy DRUG

Placebo without Vigiis 101-LAB component

placebo plus 14-day sequential therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment.

You may not qualify if:

• children and teenagers aged less than 20 years
• history of gastrectomy
• gastric malignancy, including adenocarcinoma and lymphoma
• previous allergic reaction to antibiotics (amoxicillin, metronidazole, clarithromycin, probiotics) and PPI (esomeprazole)
• contraindication to treatment drugs
• pregnant or lactating women
• severe concurrent disease
• concomitant use of clopidogrel
• unwilling to accept random assignment of subjects

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Jyh-Ming Liou

Taipei, Taiwan, 10002, Taiwan

RECRUITING

Central Study Contacts

Jyh-Ming Liou, MD

CONTACT

23123456; jyhmingliou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: October 25, 2018
• First Posted: October 29, 2018
• Study Start: August 29, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2020
• Last Updated: October 31, 2018

Record last verified: 2018-06

Locations

TW (1)