NCT02900196

Brief Summary

The purpose of this clinical study is to evaluate the effect of a four-week consumption of a fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori eradication.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

September 16, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

September 2, 2016

Last Update Submit

February 5, 2018

Conditions

Antibiotic-Associated Diarrhea

Keywords

ProbioticsAntibiotic Associated DiarrheaGastro-Intestinal disordersHelicobacter pylori

Outcome Measures

Primary Outcomes (1)

  • Occurrence of AAD

    From Day 0 to Day 28

Secondary Outcomes (7)

  • Duration of AAD

    From Day 0 to Day 28

  • Time to event of AAD

    From Day 0 to Day 28

  • Occurrence of Clostridium difficile Associated Diarrhea

    From Day 0 to Day 28

  • Time to event of Clostridium difficile Associated Diarrhea

    From Day 0 to Day 28

  • Duration of Clostridium difficile Associated Diarrhea

    From Day 0 to Day 28

  • +2 more secondary outcomes

Other Outcomes (5)

  • Clostridium difficile analysis in feces

    from Day 0 to Day 28

  • Microbiota analysis in feces

    from Day 0 to Day 42

  • Short-Chain Fatty Acids analysis in blood and feces

    from Day 0 to Day 42

  • +2 more other outcomes

Study Arms (2)

1 - Test

EXPERIMENTAL
Other: 1 - Fermented dairy drink

2 - Placebo

PLACEBO COMPARATOR
Other: 2 - Acidified dairy drink

Interventions

1 - Fermented dairy drinkOTHER

1 - Fresh fermented dairy drink containing yoghurt ferments and probiotic strains consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)

1 - Test
2 - Acidified dairy drinkOTHER

2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)

2 - Placebo

Eligibility Criteria

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

You may qualify if:

  • Subjects who have read and signed the Study Informed Consent Form
  • Subjects positive for Helicobacter pylori infection and symptomatic due to Helicobacter pylori infection
  • Subjects with an indication, as stated by a Gastroenterologist, for the eradication of Helicobacter pylori

You may not qualify if:

  • Female subjects with a positive pregnancy test (based on serum test), or planning to become pregnant during the study or breast-feeding women
  • Subject who have a history of alcohol abuse
  • Subjects having diarrhea within the preceding 4-weeks
  • Subjects with severe life-threatening illness, severe evolutive or chronic pathology
  • Immune-suppressed subjects
  • Subjects with benign peptic ulcer or pre-malignant or malignant lesion
  • Subjects presenting with an infection of the gastrointestinal tract
  • Subjects with any past severe gastro-intestinal or metabolic pathology
  • Subjects with history of Helicobacter pylori eradication therapy
  • Subjects with history of cardiac or renal clinically significant disease
  • Subjects that have had any surgery or intervention requiring general anesthesia in the last 4 weeks, or that have any planned
  • Subjects with allergy or hypersensitivity against the medication for the eradication of Helicobacter pylori
  • Subjects taking treatments likely to interfere with the evaluation of study parameters.
  • Subjects with allergy or hypersensitivity to any component of the study products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

Study Officials

  • Eric Guillemard, PhD

    Danone Research, Palaiseau, France

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 14, 2016

Study Start

September 16, 2016

Primary Completion

August 10, 2017

Study Completion

August 10, 2017

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

DE(1)