NCT02746198

Brief Summary

The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

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

January 22, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2017

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

April 12, 2016

Last Update Submit

February 5, 2021

Conditions

Antibiotic-associated Diarrhea

Keywords

Probiotics, Antibiotics, AAD, Helicobacter p.

Outcome Measures

Primary Outcomes (1)

  • Occurrence of antibiotic-associated diarrhea (AAD)

    Occurrence of antibiotic-associated diarrhea (AAD) (as defined by number of subjects with diarrhea within the intervention period of 6 weeks after starting antibiotic treatment; diarrhea is defined according WHO

    6 weeks

Secondary Outcomes (3)

  • Cumulated duration of antibiotic-associated diarrhea (AAD)

    6 weeks

  • Gastrointestinal Symptom Rating Scale

    6 weeks

  • Cumulative sverity of antibiotic-associated diarrhea (AAD)

    6 weeks

Study Arms (2)

Verum

EXPERIMENTAL

2 bottles (á 65ml) of a probiotic dairy drink consumed daily for 6 weeks

Other: probiotic dairy drink

Placebo

PLACEBO COMPARATOR

2 bottles (á 65ml) of a dairy drink containing chemically acidified milk without bacterial strains consumed daily for 6 weeks

Other: acidified milk

Interventions

probiotic dairy drinkOTHER
Also known as: verum
Verum
acidified milkOTHER
Also known as: placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals, both genders, aged ≥ 18 y
  • Helicobacter p. infected individuals, to which eradication therapy has been recommended by gastroenterologists
  • Willingness to undergo the Helicobacter p. eradication therapy
  • Willingness to abstain from food and supplements containing probiotics, prebiotics and fermented products except the study product
  • Written informed consent

You may not qualify if:

  • Subjects currently enrolled in another interventional trial
  • incapacity to comply with the study protocol
  • allergy or hypersensitivity to any component of the test product (allergy against milk protein)
  • allergy or hypersensitivity to any component of the eradication therapy (e.g. penicillin allergy)
  • acute GIT infections
  • chronic inflammatory bowel diseases (IBD)
  • irritable bowel syndrome (IBS)
  • history of lactose intolerance
  • severe chronic disease (cancer, malabsorption, malnutrition, severe chronic inflammatory diseases (except chronic gastritis), renal, hepatic or cardiac diseases, artificial cardiac valve, COPD, respiratory insufficiency)
  • history of active or persistent hepatitis B and C
  • known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
  • systemic treatment likely influencing absorption, metabolism and excretion of food ingredients (metoclopramide, laxatives, body weight management and/or medication etc.)
  • systemic treatment likely interfering or influencing effectiveness of the eradication drugs used e.g. ergotamine, statins, clopidogrel
  • regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
  • severe neurological, cognitive or psychiatric diseases
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRC Clinical Research Center Kiel

Kiel, Schleswig-Holstein, 24118, Germany

Location

MeSH Terms

Interventions

calcium D-pantothenate, L-cysteine drug combination

Study Officials

  • Chiyuki Kajita

    Yakult Europe BV

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 21, 2016

Study Start

January 22, 2016

Primary Completion

December 23, 2016

Study Completion

April 26, 2017

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)