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Alpha-galactosidase Enzyme and Irritable Bowel Syndrome (ALFA)

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Alpha-galactosidase
Sponsored by
Verman Oy Ab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gastrolääkärit OyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alpha-galactosidase

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 15, 2010
Last Updated
January 14, 2011
Sponsor
Verman Oy Ab
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1. Study Identification

Unique Protocol Identification Number
NCT01243853
Brief Title
Alpha-galactosidase Enzyme and Irritable Bowel Syndrome
Acronym
ALFA
Official Title
Alpha-galactosidase Enzyme and Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Verman Oy Ab

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alpha-galactosidase
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha-galactosidase
Intervention Description
3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo
Primary Outcome Measure Information:
Title
IBS symptom severity
Description
The IBS symptom severity score (IBS-SSS) questionnaire is used
Time Frame
baseline
Title
IBS symptom severity
Description
The IBS symptom severity score (IBS-SSS) questionnaire is used
Time Frame
1 month
Title
IBS symptom severity
Description
The IBS symptom severity score (IBS-SSS) questionnaire is used
Time Frame
2 months
Title
IBS symptom severity
Description
The IBS symptom severity score (IBS-SSS) questionnaire is used
Time Frame
3 months
Title
IBS symptom severity
Description
The IBS symptom severity score (IBS-SSS) questionnaire is used
Time Frame
follow-up (4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jari Koskenpato, MD, PhD
Phone
+358505702835
Email
jari.koskenpato@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jari Koskenpato, MD, PhD
Organizational Affiliation
Gastrolääkärit Oy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrolääkärit Oy
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jari Koskenpato, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Alpha-galactosidase Enzyme and Irritable Bowel Syndrome

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