Tolerability and Effectiveness of Progut in Treatment of Irritable Bowel Syndrome

NCT00904696 | Completed

• 1 other identifier: E/08/532
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Irritable bowel syndrome; probiotics

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is patient's tolerance with the treatment.

  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.

  3-12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (2)

• 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.

  PMID: 15765388 BACKGROUND

• Malinen 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.

  PMID: 15667495 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Khek Yu Ho, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Senior Consultant Gastroenterologist, Ho Khek Yu

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

SG (1)