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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01097993
Enrollment
120
Registered
2010-04-02
Start date
2010-02-28
Completion date
2014-01-31
Last updated
2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women With IBS-C

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

Interventions

OTHER1-fermented dairy product

Arm 1 - Intervention 1 (probiotics)

OTHER2- milk-based non-fermented dairy product (control product)

Arm 2 - Intervention 2 (control)

Sponsors

Danone Global Research & Innovation Center
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* female * Age: 18-70

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frame
Mean abdominal distension after a 4-week period of product consumption in IBS-C patients0-4 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026