A Single-centre, Randomised, Double-blind, Controlled, Pa... | NCT01097993

Studies
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)

NCT01097993

Sponsor

Danone Global Research & Innovation Center

Status

Completed

Last Update Posted

Jan 20, 2017Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Women With IBS-C

Interventions

1-fermented dairy product
2- milk-based non-fermented dairy product (control product)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jan 2014Actual

First Submitted Date

Mar 29, 2010

First Submission Date that Met QC Criteria

Apr 1, 2010

First Posted Date

Apr 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2017

Last Update Posted Date

Jan 20, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 = Tested product	Experimental		Other: 1-fermented dairy product
2 = Control product	Active Comparator		Other: 2- milk-based non-fermented dairy product (control product)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1-fermented dairy product	Other	Arm 1 - Intervention 1 (probiotics)	1 = Tested product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean abdominal distension after a 4-week period of product consumption in IBS-C patients		0-4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female
Age: 18-70

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manchester Hospital		Manchester			United Kingdom

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods