NCT01097993

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

March 29, 2010

Last Update Submit

January 18, 2017

Conditions

Women With IBS-C

Outcome Measures

Primary Outcomes (1)

  • Mean abdominal distension after a 4-week period of product consumption in IBS-C patients

    0-4 weeks

Study Arms (2)

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

1-fermented dairy productOTHER

Arm 1 - Intervention 1 (probiotics)

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

Arm 2 - Intervention 2 (control)

2 = Control product

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female
  • Age: 18-70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester Hospital

Manchester, United Kingdom

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2010

First Posted

April 2, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2012

Study Completion

January 1, 2014

Last Updated

January 20, 2017

Record last verified: 2017-01

Locations

GB(1)