NCT01388010

Brief Summary

The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
336

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

July 3, 2011

Last Update Submit

October 26, 2016

Conditions

Healthy Adult Women

Keywords

probioticsgastrointestinal well beingdigestive symptomshealthy population

Study Arms (2)

1 = Test product

EXPERIMENTAL

Arm 1 - Intervention 1 (probiotics)

Other: 1-Fermented Probiotic Dairy Product (test)

2 = Control product

OTHER

Arm 2 - Intervention 2 (control)

Other: 2-Milk-based non-fermented dairy product(control)

Interventions

1-Fermented Probiotic Dairy Product (test)OTHER
1 = Test product
2-Milk-based non-fermented dairy product(control)OTHER
2 = Control product

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female free-living subject aged from 18 to 60 years.
  • Subject with a body mass index between 18 and 30.
  • Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms.
  • Subject with normal stool frequency

You may not qualify if:

  • Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, diarrhoea…)
  • Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
  • Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs
  • Subject having taken antibiotics in the last 4 weeks
  • Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
  • Subject with known lactose intolerance or immunodeficiency
  • Subject with known allergy to product component (milk protein for example)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RPS Research France

Caen, 14052, France

Location

Study Design

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

Study Record Dates

First Submitted

July 3, 2011

First Posted

July 6, 2011

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

October 1, 2010

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

FR(1)