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

Danone

Status: Completed

Conditions: Healthy; Constipation

Treatments: Other: Fermented milk product containing Probiotics; Other: Non fermented Milk Product; Other: Fermented Milk Product containing Probiotics + Fibers C; Other: Fermented Milk Product containing Probiotics + Fibers W

Study type: Interventional

Funder types: Industry

Identifiers

NCT02461485

NU373

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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153 participants in 4 patient groups, including a placebo group

1=BOW_01

Experimental group

Description:

1= Fermented Milk Product containing Probiotics

Treatment:

Other: Fermented milk product containing Probiotics

2=BOW_01 + fiber C

Experimental group

Description:

2= Fermented Milk Product containing Probiotics + Fibers C

Treatment:

Other: Fermented Milk Product containing Probiotics + Fibers C

3 =BOW_01 + fiber W

Experimental group

Description:

3= Fermented Milk Product containing Probiotics + Fibers W

Treatment:

Other: Fermented Milk Product containing Probiotics + Fibers W

4 = Control

Placebo Comparator group

Description:

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

Treatment:

Other: Non fermented Milk Product