Irritable Bowel SyndromeALFANCT01243853
Alpha-galactosidase Enzyme and Irritable Bowel Syndrome
A study testing Alpha-galactosidase in people with Irritable Bowel Syndrome, run by Verman Oy Ab at 1 site in Finland.
Trial summary
The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Alpha-galactosidase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Gastrolääkärit Oy
Helsinki, 00100
Jari Koskenpato, MD, PhD
About this study
The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Alpha-galactosidase
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-galactosidaseDietary supplement
3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo
| Study group | Role | What they receive |
|---|---|---|
| Alpha-galactosidase | Active comparator | Not described Receives: Dietary Supplement: Alpha-galactosidase |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Alpha-galactosidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS symptom severity
The IBS symptom severity score (IBS-SSS) questionnaire is used
Measured: baseline
IBS symptom severity
The IBS symptom severity score (IBS-SSS) questionnaire is used
Measured: 1 month
IBS symptom severity
The IBS symptom severity score (IBS-SSS) questionnaire is used
Measured: 2 months
IBS symptom severity
The IBS symptom severity score (IBS-SSS) questionnaire is used
Measured: 3 months
IBS symptom severity
The IBS symptom severity score (IBS-SSS) questionnaire is used
Measured: follow-up (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verman Oy Ab
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jari Koskenpato, MD, PhD, Principal investigator, Gastrolääkärit Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243853
- Sponsor's protocol ID
- VER001
- Acronym
- ALFA
- Status last verified
- Jan 2011
- First submitted
- 15 Nov 2010
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-galactosidase Enzyme and Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01243853
- Acronym / sponsor ID
- ALFA / VER001
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Verman Oy AbIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether alpha-galactosidase enzyme is affective in alleviating the symptoms of irritable bowel syndrome (IBS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-galactosidase | Active comparator | Dietary Supplement: Alpha-galactosidase |
| Placebo | Placebo comparator | Dietary Supplement: Alpha-galactosidase |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-galactosidase3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo | Dietary supplement | Alpha-galactosidase, Placebo |
Primary outcome
IBS symptom severity
Time frame: baseline
The IBS symptom severity score (IBS-SSS) questionnaire is used
IBS symptom severity
Time frame: 1 month
The IBS symptom severity score (IBS-SSS) questionnaire is used
IBS symptom severity
Time frame: 2 months
The IBS symptom severity score (IBS-SSS) questionnaire is used
IBS symptom severity
Time frame: 3 months
The IBS symptom severity score (IBS-SSS) questionnaire is used
IBS symptom severity
Time frame: follow-up (4 months)
The IBS symptom severity score (IBS-SSS) questionnaire is used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari Koskenpato, MD, PhD principal investigator
Gastrolääkärit Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-galactosidase in people with Irritable Bowel Syndrome, run by Verman Oy Ab at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jari Koskenpato, MD, PhD (+358505702835, jari.koskenpato@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS symptom severity (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2011.