A Single-centre, Randomised, Double-blind, Controlled, Parallel-group Study to Evaluate the Effect of a Fermented Dairy Product on Abdominal Distension, Digestive Symptoms and Rectal Sensitivity in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Danone

Status: Completed

Conditions: Women With IBS-C

Treatments: Other: 2- milk-based non-fermented dairy product (control product); Other: 1-fermented dairy product

Study type: Interventional

Funder types: Industry

Identifiers

NCT01097993

NU324

Details and patient eligibility

About

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 abdominal distension in IBS patients with constipation (IBS-C).

Enrollment: 120 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female
• Age: 18-70

Exclusion criteria

• NA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

1 = Tested product

Experimental group

Treatment:

Other: 1-fermented dairy product

2 = Control product

Active Comparator group

Treatment:

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