NCT02461485

Brief Summary

First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2015

Typical duration for not_applicable healthy

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

First Submitted

Initial submission to the registry

April 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

April 24, 2015

Last Update Submit

August 21, 2017

Conditions

HealthyConstipation

Keywords

adultsmoderate constipation

Outcome Measures

Primary Outcomes (8)

  • Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.

    Baseline and after 4 weeks.

  • Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.

    Baseline and after 4 weeks.

  • Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.

    Baseline and during the 4th week.

  • Change in fecal bulk (stool weight) at baseline and after 4 weeks.

    Baseline and after 4 weeks.

  • Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.

    Baseline and after 2 and 4 weeks. Validated questionnaire.

  • Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks.

    Baseline and after 2 and 4 weeks. Validated questionnaire.

  • Study product satisfaction by questionnaire after 2 and 4 weeks.

    after 2 and 4 weeks.

  • Adverse events in the week before baseline, at baseline, week 3, 4 and 5.

    Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study)

Study Arms (4)

1=BOW_01

EXPERIMENTAL

1= Fermented Milk Product containing Probiotics

Other: Fermented milk product containing Probiotics

2=BOW_01 + fiber C

EXPERIMENTAL

2= Fermented Milk Product containing Probiotics + Fibers C

Other: Fermented Milk Product containing Probiotics + Fibers C

3 =BOW_01 + fiber W

EXPERIMENTAL

3= Fermented Milk Product containing Probiotics + Fibers W

Other: Fermented Milk Product containing Probiotics + Fibers W

4 = Control

PLACEBO COMPARATOR

4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3.

Other: Non fermented Milk Product

Interventions

Fermented milk product containing ProbioticsOTHER

2 pots/day during 28 days

1=BOW_01
Fermented Milk Product containing Probiotics + Fibers COTHER

2 pots/day during 28 days

2=BOW_01 + fiber C
Fermented Milk Product containing Probiotics + Fibers WOTHER

2 pots/day during 28 days

3 =BOW_01 + fiber W
Non fermented Milk ProductOTHER

2 pots/day during 28 days

4 = Control

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Main eligibility criteria (non-exhaustive list) are defined as: * Healthy Caucasian subject of both gender, aged from 18 to 69 years * Subject with body mass index (BMI) between 18 kg/m2 (bound included) and 30 kg/m2 (bound excluded) * Subjects with moderate constipation defined according to ROME III adapted criteria. * Subjects without ongoing or diagnosed gastrointestinal disease or complications. * Subjects without previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function. * Subjects without known gluten intolerance, lactose intolerance or allergy to milk proteins.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 24, 2015

First Posted

June 3, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

October 12, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

IE(1)