Alpha-galactosidase Enzyme and Irritable Bowel Syndrome (ALFA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Verman Oy Ab.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Verman Oy Ab
ClinicalTrials.gov Identifier:
NCT01243853
First received: November 15, 2010
Last updated: January 14, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention
Irritable Bowel Syndrome
Dietary Supplement: Alpha-galactosidase

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Alpha-galactosidase Enzyme and Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Verman Oy Ab:

Primary Outcome Measures:
  • IBS symptom severity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used

  • IBS symptom severity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used

  • IBS symptom severity [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used

  • IBS symptom severity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used

  • IBS symptom severity [ Time Frame: follow-up (4 months) ] [ Designated as safety issue: No ]
    The IBS symptom severity score (IBS-SSS) questionnaire is used


Estimated Enrollment: 150
Study Start Date: December 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jari Koskenpato/Principal Investigator, Gastrolääkärit Oy
ClinicalTrials.gov Identifier: NCT01243853     History of Changes
Other Study ID Numbers: VER001
Study First Received: November 15, 2010
Last Updated: January 14, 2011
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on October 20, 2014