Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms

Not Applicable

Completed

• Conditions: Constipation; Healthy
• Interventions: Other: Non fermented Milk Product; Other: Fermented milk product containing Probiotics; Other: Fermented Milk Product containing Probiotics + Fibers C; Other: Fermented Milk Product containing Probiotics + Fibers W

• Registration Number: NCT02461485
• Lead Sponsor: Danone Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-24
• Study Start: 2015-05
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Primary Completion: 2016-07
• Study Completion: 2016-10-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 = Control	Non fermented Milk Product	4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3.
1=BOW_01	Fermented milk product containing Probiotics	1= Fermented Milk Product containing Probiotics
2=BOW_01 + fiber C	Fermented Milk Product containing Probiotics + Fibers C	2= Fermented Milk Product containing Probiotics + Fibers C
3 =BOW_01 + fiber W	Fermented Milk Product containing Probiotics + Fibers W	3= Fermented Milk Product containing Probiotics + Fibers W

Primary Outcome Measures

Name	Time	Method
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 fecal bulk (stool weight) at baseline and after 4 weeks.	Baseline and after 4 weeks.
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.
Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.	Baseline and after 2 and 4 weeks. Validated questionnaire.
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)
Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.	Baseline and during the 4th week.
Study product satisfaction by questionnaire after 2 and 4 weeks.	after 2 and 4 weeks.

Trial Locations

Locations (1)

Atlantia Food Clinical Trials; 🇮🇪 Cork, Ireland