ClinicalTrials.gov
ClinicalTrials.gov Menu

Alpha-galactosidase Enzyme and Irritable Bowel Syndrome (ALFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01243853
Recruitment Status : Unknown
Verified January 2011 by Verman Oy Ab.
Recruitment status was:  Recruiting
First Posted : November 19, 2010
Last Update Posted : January 17, 2011
Sponsor:
Information provided by:
Verman Oy Ab

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Alpha-galactosidase Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Alpha-galactosidase Enzyme and Irritable Bowel Syndrome
Study Start Date : December 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. IBS symptom severity [ Time Frame: baseline ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used

  2. IBS symptom severity [ Time Frame: 1 month ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used

  3. IBS symptom severity [ Time Frame: 2 months ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used

  4. IBS symptom severity [ Time Frame: 3 months ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used

  5. IBS symptom severity [ Time Frame: follow-up (4 months) ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243853


Contacts
Contact: Jari Koskenpato, MD, PhD +358505702835 jari.koskenpato@hus.fi

Locations
Finland
Gastrolääkärit Oy Recruiting
Helsinki, Finland, 00100
Principal Investigator: Jari Koskenpato, MD, PhD         
Sponsors and Collaborators
Verman Oy Ab
Investigators
Principal Investigator: Jari Koskenpato, MD, PhD Gastrolääkärit Oy

Responsible Party: Jari Koskenpato/Principal Investigator, Gastrolääkärit Oy
ClinicalTrials.gov Identifier: NCT01243853     History of Changes
Other Study ID Numbers: VER001
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: January 17, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases