NCT01243853

Brief Summary

The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 17, 2011

Status Verified

January 1, 2011

Enrollment Period

1 year

First QC Date

November 15, 2010

Last Update Submit

January 14, 2011

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (5)

  • IBS symptom severity

    The IBS symptom severity score (IBS-SSS) questionnaire is used

    baseline

  • IBS symptom severity

    The IBS symptom severity score (IBS-SSS) questionnaire is used

    1 month

  • IBS symptom severity

    The IBS symptom severity score (IBS-SSS) questionnaire is used

    2 months

  • IBS symptom severity

    The IBS symptom severity score (IBS-SSS) questionnaire is used

    3 months

  • IBS symptom severity

    The IBS symptom severity score (IBS-SSS) questionnaire is used

    follow-up (4 months)

Study Arms (2)

Alpha-galactosidase

ACTIVE COMPARATOR
Dietary Supplement: Alpha-galactosidase

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Alpha-galactosidase

Interventions

Alpha-galactosidaseDIETARY_SUPPLEMENT

3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo

Alpha-galactosidasePlacebo

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of IBS according to Rome III criteria, additionally abdominal distension or flatulence the most disturbing symptom
  • Age 18-65 years
  • Colonoscopy conducted within the previous 5 years, finding macroscopically and histologically normal

You may not qualify if:

  • Organic GI disease. Treated (min. 1 year) coeliac disease patients, and subjects with known and treated lactose intolerance are allowed to participate
  • Malignancy
  • Significant gastrointestinal surgery
  • Clinically significant aberrancies in the screening-phase laboratory analyses
  • Changes in regular medication during the previous 4 weeks
  • Pregnancy or breast feeding
  • Other disease or state that based on the investigator's evaluation complicates the conduction of the intervention, i.e. alcoholism, dementia
  • Hereditary galactosemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrolääkärit Oy

Helsinki, 00100, Finland

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

alpha-Galactosidase

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

GalactosidasesGlycoside HydrolasesHydrolasesEnzymesEnzymes and Coenzymes

Study Officials

  • Jari Koskenpato, MD, PhD

    Gastrolääkärit Oy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jari Koskenpato, MD, PhD

CONTACT

+358505702835jari.koskenpato@hus.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 19, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

January 17, 2011

Record last verified: 2011-01

Locations

FI(1)