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Tolerability and Effectiveness of Progut in Treatment of Irritable Bowel Syndrome

NCT00904696 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2014-04-28

No results posted yet for this study

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. 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.

Conditions

  • Irritable Bowel Syndrome (IBS)

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Khek Yu Ho, MD · National University Hospital, Singapore

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904696 on ClinicalTrials.gov