Irritable Bowel Syndrome (IBS)NCT00904696
Tolerability and Effectiveness of Progut in Treatment of Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome (IBS), run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Irritable bowel syndrome (IBS) is a very common chronic functional gastrointestinal disorder characterised by abdominal pain/discomfort, bloating and alterations in bowel function. This condition significantly impairs quality of life and places a large burden on health care resources. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- May 2009to Sep 2009
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study subjects will be patients aged 18 years and older, diagnosed with IBS by their own physicians, and determined to be eligible to receive a prescription for Progut. In addition, they must satisfy the inclusion criteria stated below, be able to communicate well, provide written informed consent required by local regulations and willing to participate in the entire study.
Who may be able to join
- Patients aged 18 and above with IBS diagnosed by the presence of the following symptoms:
- abdominal pain,
- bloating and constipation in whom organic pathology has been excluded
- All patients would have had endoscopy done in the past 3 years to exclude organic lower gastrointestinal pathology.
- All patients would have been prescribed Progut (1-3 capsules per day)by their physicians.
Who cannot join
- Women who are pregnant, intending to become pregnant or breastfeeding.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Immunocompromised patients
- Hypersensitivity to Progut
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Tolerability & Effectiveness of Progut in Treatment of Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a very common chronic functional gastrointestinal disorder characterised by abdominal pain/discomfort, bloating and alterations in bowel function. This condition significantly impairs quality of life and places a large burden on health care resources. Existing therapies for IBS are far from being satisfactory and new therapies are being constantly sought.
The pathogenesis of IBS remains unclear. Imbalance in the intestinal microbiota is considered to be one important etiologic factor for IBS. That some probiotics are effective in the prevention and treatment of IBS supports this idea.
Read more
Progut is a synbiotic: a combination of probiotics and prebiotics. Probiotics are viable beneficial bacteria that are normally present in a healthy digestive tract. Each capsule of Progut contains 9 billion viable bacteria from 8 different strains that are characteristics of a healthy normal gut microflora: Lactobacillus (L. acidophilus, L. casei, L. lactis, and L. bulgaricus); Bifidobacterium (B. longum, B. infantis and B. bifidum); and Streptococcus thermophilus at time of manufacturing. To ensure survival of these bacteria, Progut is encapsulated and enteric-coated.
The primary objective is to evaluate the tolerability of Progut treatment 1-3 capsules/day in patients with irritable bowel syndrome under the same conditions as those likely to be encountered in a standard general clinical practice or outpatient clinic.
The rationale for this study is to obtain tolerability data in patients with IBS in the Singapore. The secondary objectives are to evaluate the patients' satisfaction and symptom improvement with Progut treatment.
Read the detailed description
This will be an open-label, single arm post marketing surveillance study involving an active treatment period of a minimum 3-week and a maximum 12-week duration. Treatment with Progut will be at the discretion of the attending doctor and decision is independent of this study. This study will only recruit patients following the prescription of Progut and follow them up for upto a maximum of 12 weeks.
At Visit 1 (Day 1), the eligible patients will receive a prescription for Progut from their physician. Depending on the discretion of the attending physician, they will be prescribed Progut for treatment duration lasting 3 to 12 weeks. Safety of Progut under normal clinical use will be assessed at the end of this period. Perception of effectiveness, and tolerability of treatment will be assessed on Day 8-15 using a phone interview. On Visit 2 (any time between Day 22 to 85, depending on duration of treatment given and schedule of their follow-up visit arranged by the attending physician), the patient will be evaluated for symptomatic improvement, perception of effectiveness, tolerability and satisfaction with treatment, following which he/she will formally exit the study.
This study design was chosen with the aim of recruiting rapidly a large cohort of patients representative of the population being prescribed Progut. A total of 50 patients will be included to allow for an assessment of patient's tolerability of Progut, as well as satisfaction and perception of effectiveness and symptom response in the Singapore population.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Irritable bowel syndrome, probiotics
- Medical subject headings
- Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is patient's tolerance with the treatment.
Measured: 3-12 weeks
Secondary outcomes (1)
Secondary endpoints are the resolution of gastrointestinal symptoms as assessed by a symptom questionnaire, patient's perception of effectiveness of the treatment and their overall satisfaction with the treatment.
Measured: 3-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
- Investigators
- Khek Yu Ho, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904696
- Sponsor's protocol ID
- E/08/532
- Status last verified
- Apr 2014
- First submitted
- 19 May 2009
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Mahony L, McCarthy J, Kelly P, Hurley G, Luo F, Chen K, O'Sullivan GC, Kiely B, Collins JK, Shanahan F, Quigley EM. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. 2005 Mar;128(3):541-51. doi: 10.1053/j.gastro.2004.11.050.
PubMed 15765388Malinen E, Rinttila T, Kajander K, Matto J, Kassinen A, Krogius L, Saarela M, Korpela R, Palva A. Analysis of the fecal microbiota of irritable bowel syndrome patients and healthy controls with real-time PCR. Am J Gastroenterol. 2005 Feb;100(2):373-82. doi: 10.1111/j.1572-0241.2005.40312.x.
PubMed 15667495
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tolerability & Effectiveness of Progut in Treatment of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00904696
- Acronym / sponsor ID
- E/08/532
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Irritable bowel syndrome, probiotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 May 2009 (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.
Irritable bowel syndrome (IBS) is a very common chronic functional gastrointestinal disorder characterised by abdominal pain/discomfort, bloating and alterations in bowel function. This condition significantly impairs quality of life and places a large burden on health care resources. Existing therapies for IBS are far from being satisfactory and new therapies are being constantly sought.
The pathogenesis of IBS remains unclear. Imbalance in the intestinal microbiota is considered to be one important etiologic factor for IBS. That some probiotics are effective in the prevention and treatment of IBS supports this idea.
Progut is a synbiotic: a combination of probiotics and prebiotics. Probiotics are viable beneficial bacteria that are normally present in a healthy digestive tract. Each capsule of Progut contains 9 billion viable bacteria from 8 different strains that are characteristics of a healthy normal gut microflora: Lactobacillus (L. acidophilus, L. casei, L. lactis, and L. bulgaricus); Bifidobacterium (B. longum, B. infantis and B. bifidum); and Streptococcus thermophilus at time of manufacturing. To ensure survival of these bacteria, Progut is encapsulated and enteric-coated.
The primary objective is to evaluate the tolerability of Progut treatment 1-3 capsules/day in patients with irritable bowel syndrome under the same conditions as those likely to be encountered in a standard general clinical practice or outpatient clinic.
The rationale for this study is to obtain tolerability data in patients with IBS in the Singapore. The secondary objectives are to evaluate the patients' satisfaction and symptom improvement with Progut treatment.
Detailed description
This will be an open-label, single arm post marketing surveillance study involving an active treatment period of a minimum 3-week and a maximum 12-week duration. Treatment with Progut will be at the discretion of the attending doctor and decision is independent of this study. This study will only recruit patients following the prescription of Progut and follow them up for upto a maximum of 12 weeks.
At Visit 1 (Day 1), the eligible patients will receive a prescription for Progut from their physician. Depending on the discretion of the attending physician, they will be prescribed Progut for treatment duration lasting 3 to 12 weeks. Safety of Progut under normal clinical use will be assessed at the end of this period. Perception of effectiveness, and tolerability of treatment will be assessed on Day 8-15 using a phone interview. On Visit 2 (any time between Day 22 to 85, depending on duration of treatment given and schedule of their follow-up visit arranged by the attending physician), the patient will be evaluated for symptomatic improvement, perception of effectiveness, tolerability and satisfaction with treatment, following which he/she will formally exit the study.
This study design was chosen with the aim of recruiting rapidly a large cohort of patients representative of the population being prescribed Progut. A total of 50 patients will be included to allow for an assessment of patient's tolerability of Progut, as well as satisfaction and perception of effectiveness and symptom response in the Singapore population.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study subjects will be patients aged 18 years and older, diagnosed with IBS by their own physicians, and determined to be eligible to receive a prescription for Progut. In addition, they must satisfy the inclusion criteria stated below, be able to communicate well, provide written informed consent required by local regulations and willing to participate in the entire study.
Key inclusion criteria (5 listed)
- Patients aged 18 and above with IBS diagnosed by the presence of the following symptoms:
- All patients would have had endoscopy done in the past 3 years to exclude organic lower gastrointestinal pathology.
- All patients would have been prescribed Progut (1-3 capsules per day)by their physicians.
Key exclusion criteria (4 listed)
- Women who are pregnant, intending to become pregnant or breastfeeding.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Immunocompromised patients
- Hypersensitivity to Progut
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint is patient's tolerance with the treatment.
Time frame: 3-12 weeks
1 secondary outcome
Secondary endpoints are the resolution of gastrointestinal symptoms as assessed by a symptom questionnaire, patient's perception of effectiveness of the treatment and their overall satisfaction with the treatment.
Time frame: 3-12 weeks
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 28 Apr 2014.
- Background: PubMed 15765388O'Mahony L, McCarthy J, Kelly P, Hurley G, Luo F, Chen K, O'Sullivan GC, Kiely B, Collins JK, Shanahan F, Quigley EM. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. 2005 Mar;128(3):541-51. doi: 10.1053/j.gastro.2004.11.050.
- Background: PubMed 15667495Malinen E, Rinttila T, Kajander K, Matto J, Kassinen A, Krogius L, Saarela M, Korpela R, Palva A. Analysis of the fecal microbiota of irritable bowel syndrome patients and healthy controls with real-time PCR. Am J Gastroenterol. 2005 Feb;100(2):373-82. doi: 10.1111/j.1572-0241.2005.40312.x.
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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.
Khek Yu Ho, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome (IBS), run by National University Hospital, Singapore at 1 site in Singapore.
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 5 inclusion and 4 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 28 Apr 2014. 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 Singapore. 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.
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 endpoint is patient's tolerance with the treatment. (time frame: 3-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00904696, which also lists 2 linked publications.
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 28 Apr 2014.