NCT02725138

Brief Summary

We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

March 27, 2016

Last Update Submit

June 27, 2021

Conditions

Helicobacter

Keywords

Helicobacter pyloriprobioticbacterial density

Outcome Measures

Primary Outcomes (1)

  • Reduction of bacterial load of H. pylori

    after 4 weeks of treatment

Secondary Outcomes (2)

  • changes in gut microbiota

    after 4 weeks of treatment

  • adverse effects

    4 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

subjects will be treated with probiotic containing Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

subjects will be treated with placebo without Lactobacillus acidophilus，Lactobacillus rhamnosus, 1pack, twice daily, for 4 weeks

Other: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

Probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks

Probiotic
PlaceboOTHER

Placebo without Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial

You may not qualify if:

  • history of gastrectomy and colectomy
  • severe underlying illness, such as malignancy, ESRD, liver failure, etc
  • allergy to probiotics
  • symptomatic patients who need PPI, antibiotics, or other probiotics
  • pregnancy and lactating women
  • unable to cooperate with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (1)

  • Chen MJ, Chen CC, Huang YC, Tseng CC, Hsu JT, Lin YF, Fang YJ, Wu MS, Liou JM; Taiwan Gastrointestinal Disease, Helicobacter Consortium. The efficacy of Lactobacillus acidophilus and rhamnosus in the reduction of bacterial load of Helicobacter pylori and modification of gut microbiota-a double-blind, placebo-controlled, randomized trial. Helicobacter. 2021 Dec;26(6):e12857. doi: 10.1111/hel.12857. Epub 2021 Oct 27.

    PMID: 34708471DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jyh-Ming Liou, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

March 27, 2016

First Posted

March 31, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2017

Study Completion

December 1, 2020

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)