Alpha-galactosidase Enzyme and Irritable Bowel Syndrome (ALFA)

January 14, 2011 updated by: Verman Oy Ab
The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00100
        • Recruiting
        • Gastrolääkärit Oy
        • Principal Investigator:
          • Jari Koskenpato, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Alpha-galactosidase
3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo
Active Comparator: Alpha-galactosidase
Dietary supplement: Alpha-galactosidase
3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS symptom severity
Time Frame: baseline
The IBS symptom severity score (IBS-SSS) questionnaire is used
baseline
IBS symptom severity
Time Frame: 1 month
The IBS symptom severity score (IBS-SSS) questionnaire is used
1 month
IBS symptom severity
Time Frame: 2 months
The IBS symptom severity score (IBS-SSS) questionnaire is used
2 months
IBS symptom severity
Time Frame: 3 months
The IBS symptom severity score (IBS-SSS) questionnaire is used
3 months
IBS symptom severity
Time Frame: follow-up (4 months)
The IBS symptom severity score (IBS-SSS) questionnaire is used
follow-up (4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verman Oy Ab

Investigators

  • Principal Investigator: Jari Koskenpato, MD, PhD, Gastrolääkärit Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

January 17, 2011

Last Update Submitted That Met QC Criteria

January 14, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VER001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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