Tolerability and Effectiveness of Progut in Treatment of Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00904696
First received: May 19, 2009
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition
Irritable Bowel Syndrome (IBS)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Tolerability & Effectiveness of Progut in Treatment of Irritable Bowel Syndrome

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • The primary endpoint is patient's tolerance with the treatment. [ Time Frame: 3-12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  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: NCT00904696

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Khek Yu Ho, MD National University Hospital, Singapore
  More Information

Publications:
Responsible Party: Medicine, Professor & Senior Consultant Gastroenterologist, Ho Khek Yu, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00904696     History of Changes
Other Study ID Numbers: E/08/532
Study First Received: May 19, 2009
Last Updated: April 24, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
Irritable bowel syndrome
probiotics

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

ClinicalTrials.gov processed this record on July 10, 2014