NCT01010191

Brief Summary

Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

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

July 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

1.8 years

First QC Date

November 5, 2009

Last Update Submit

June 21, 2011

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndromeno organic digestive disease

Outcome Measures

Primary Outcomes (1)

  • IBS Global Improvement Scale

    3 weeks

Secondary Outcomes (3)

  • IBS Adequate Relief

    3 weeks

  • IBS quality of life (QoL)

    3 weeks

  • IBS Symptom Severity Scale

    3 weeks

Study Arms (2)

Cellulose pill

EXPERIMENTAL

The active intervention is a sugar pill.

Other: Sugar pill

No treatment

NO INTERVENTION

The control arm is wait list control

Interventions

Sugar pillOTHER
Cellulose pill

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Irritable bowel syndrome.

You may not qualify if:

  • Any signs of organic bowel disease such as rectal bleeding.
  • No other major illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.

    PMID: 21203519DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Sugars

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 9, 2009

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

US(1)