Irritable Bowel SyndromePhase 3NCT00135031
Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome
A Phase 3 study testing Bifidobacterium infantis 35624 in people with Irritable Bowel Syndrome, run by Procter and Gamble at 20 sites in United Kingdom.
Trial summary
The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Bifidobacterium infantis 35624
- How many people
- 362 participants
- Where
- 20 sitesUnited Kingdom
- Study dates
- Jan 2004to Sep 2004
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet Rome II criteria for the diagnosis of IBS
- Refrain from using probiotic supplements during the trial
Who cannot join
- Organic diseases, including inflammatory bowel disease, and significant systemic diseases
- Subjects over 55 years of age that had not had a sigmoidoscopy or colonoscopy performed in the previous five years
- Use of anti-psychotic medications within the prior three months
- Had major psychiatric disorder (DSM-II-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse, within the past two years
- Were pregnant or nursing
- Had known lactose intolerance or immunodeficiency
- Had undergone any abdominal surgery, with the exception of hernia repair or appendectomy
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United Kingdom20 sites
Stanwell Road Surgery
Ashford, Middlesex, TW18 1SL
Springhill Surgery
Bangor, County Down, BT19 1PP
Little Common Surgery
Bexhill-on-Sea, East Sussex, TN39 5JB
Sea Road Surgery
Bexhill-on-Sea, East Sussex, TN40 1JJ
The Orchard Medical Centre
Bristol, Bristol, BS15 2NJ
The Penylan Surgery
Cardiff, Wales, CF23 5SY
Hathaway Surgery
Chippenham, Wiltshire, SN15 1HP
The Burns Practice
Doncaster, South Yorkshire, DN1 2EG
Downpatrick Health Centre
Downpatrick, County Down, BT30 6HY
The Medical Centre
East Horsley, Surrey, KT 24 6QT
The Frome Medical Practice
Frome, Somerset, BA11 1EZ
Old School Surgery
Greenisland, County Antrim, BT38 8TP
Belmont Health Centre
Harrow, Middlesex, HA3 7LT
Valleyfield Health Centre
High Valleyfield, Fife, KY 12 8SJ
Yaxley Group Practice, The Health Centre
Peterborough, Cambridgeshire, PE7 3JL
Sherbourne Medical Centre
Royal Leamington Spa, Warwickshire, CV32 4RA
The Burngreave Surgery
Sheffield, South Yorkshire, S3 9DA
The Staploe Medical Centre
Soham, Cambridgeshire, CB7 5JD
Swindon Medical Research Centre, Abbeymeads Medical
Swindon, Wiltshire, SN25 4YZ
Wansford Surgery
Wansford, Cambridgeshire, PE8 6PL
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Safety and Efficacy Evaluation of Bifidobacterium Infantis 35624 in Female Subjects With Irritable Bowel Syndrome
The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome (IBS).
Read the detailed description
The pathogenesis of irritable bowel syndrome (IBS) may have a a post-infectious inflammatory component, suggesting that altered gut bacterial flora are of relevance and that probiotics may be beneficial. This clinical trial examined the efficacy of an encapsulated probiotic in subjects with Rome II IBS. After a 2 week baseline, 362 female subjects were randomized to placebo or one of three doses of B. infantis 35624 once daily for 4 weeks. IBS symptoms were monitored daily and scored according to a 6-point Likert scale; stool frequency and form were also monitored daily. The primary efficacy variable was the abdominal pain score; secondary efficacy variables included other IBS symptom relief and quality of life.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Bifidobacterium infantis 35624
- 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.
Bifidobacterium infantis 35624Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable was the abdominal pain score
Secondary outcomes (1)
Bloating/distension, sense of incomplete evacuation, straining, urgency, passage of gas, number of bowel movements, passage of mucus, a composite symptom score, subject's assessment of IBS symptom relief, and quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startJan 2004
- Primary completionSep 2004
- Study completionSep 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 362 participants
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alimentary Health Ltd
- Investigators
- Peter J. Whorwell, M.D., Principal investigator, Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135031
- Sponsor's protocol ID
- 2002089
- Status last verified
- Jun 2011
- First submitted
- 23 Aug 2005
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Safety and Efficacy Evaluation of Bifidobacterium Infantis 35624 in Female Subjects With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00135031
- Acronym / sponsor ID
- 2002089
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Collaborators
- Alimentary Health Ltd
- Study start
- Jan 2004
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 25 Aug 2005 (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 was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome (IBS).
Detailed description
The pathogenesis of irritable bowel syndrome (IBS) may have a a post-infectious inflammatory component, suggesting that altered gut bacterial flora are of relevance and that probiotics may be beneficial. This clinical trial examined the efficacy of an encapsulated probiotic in subjects with Rome II IBS. After a 2 week baseline, 362 female subjects were randomized to placebo or one of three doses of B. infantis 35624 once daily for 4 weeks. IBS symptoms were monitored daily and scored according to a 6-point Likert scale; stool frequency and form were also monitored daily. The primary efficacy variable was the abdominal pain score; secondary efficacy variables included other IBS symptom relief and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet Rome II criteria for the diagnosis of IBS
- Refrain from using probiotic supplements during the trial
Key exclusion criteria (7 listed)
- Organic diseases, including inflammatory bowel disease, and significant systemic diseases
- Subjects over 55 years of age that had not had a sigmoidoscopy or colonoscopy performed in the previous five years
- Use of anti-psychotic medications within the prior three months
- Had major psychiatric disorder (DSM-II-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse, within the past two years
- Were pregnant or nursing
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 |
|---|---|---|
| Bifidobacterium infantis 35624 | Drug | – |
Primary outcome
The primary efficacy variable was the abdominal pain score
1 secondary outcome
Bloating/distension, sense of incomplete evacuation, straining, urgency, passage of gas, number of bowel movements, passage of mucus, a composite symptom score, subject's assessment of IBS symptom relief, and quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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.
Peter J. Whorwell, M.D. principal investigator
Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bifidobacterium infantis 35624 in people with Irritable Bowel Syndrome, run by Procter and Gamble at 20 sites in United Kingdom.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy variable was the abdominal pain score. 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 15 Jun 2011.