Study to Determine Efficacy of Probiotics in Irritable Bowel Syndrome

NCT02545413 | Withdrawn Phase 3

• 1 other identifier: IRC/2015/protocol/24
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is the most common functional GI disorder in which abdominal pain and/or discomfort is associated with changes in bowel habit, and with features of disordered defecation. IBS affects 10-20% of the population and causes a marked reduction of quality of life in affected individuals.The high prevalence of IBS is accompanied by large societal economic burdens and negative effects on the quality of life in affected patients. It is divided into 3 types IBS-D diarrhea predominant, IBS-C constipation predominant, IBS-M mixed sub type.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Comparison of the intensity of abdominal pain relief and change in stool consistency before and after treatment, between the two arms

  The defecation component of the primary endpoint will be evaluated by assessing stool consistency as per "Bristol Stool Form Scale". Abdominal pain component of primary end point will be accessed by using an 11-point (i.e., 0 to 10) numeric rating scale that asks patients daily to rate their worst abdominal pain over the past 24-hours

  8 wks (after end of treatment)

Secondary Outcomes (3)

• Comparison of Quality of Life parameters as measured by IBS-QoL Questionnaire before and after treatment, between the 2 arms

  8 wks (after end of treatment) and 20 weeks (12 weeks after end of follow-up period; at end of study)

• Comparison of Quality of Life parameters as measured by SF-36 Questionnaire before and after treatment, between the 2 arms

  8 wks (after end of treatment) and 20 weeks (12 weeks after end of follow-up period; at end of study)

• Comparison of Visceral hypersensitivity/Rectal sensitivity before and after treatment between the two arms

  8 wks (after end of treatment)

Study Arms (2)

Probiotic

EXPERIMENTAL

Probiotic VSL#3 will be given at a dose of one capsule thrice daily for 8 weeks, amounting to a total of 337.5 billion CFU/day. Each capsule contains 112.5 billion viable lyophilized bacteria of four strains of Lactobacillus (L. acidophilus DSM 24735, L. plantarum DSM 24730, L. paracasei DSM 24733, L. delbrueckii subsp. bulgaricus DSM 24734), three strains of Bifidobacterium (B. longum DSM 24736, B. breve DSM 24732, B. infantis DSM 24737) and one strain of Streptococcus (S. thermophilus DSM 24731) and excipients.

Drug: Probiotic VSL#3

Placebo

PLACEBO COMPARATOR

Placebo capsules will be given at a dose of one capsule thrice daily for 8 weeks; Placebo capsules contain all excipients as present in capsules (without the 8 strains of bacteria as mentioned above).

Drug: Placebo

Interventions

Probiotic VSL#3 DRUG

Probiotic

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive diagnoses of IBS subtype IBS-D defined by Rome III criteria, and who meet the following criteria:
• a) Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) b) abdominal pain score of \> 3.0 on a 0 to 10 point scale \& c) Stool Consistency of at least one stool with a consistency of Type 6 or Type 7 Bristol stool score (BSS) on at least 2 days per week
• Signed informed consent

You may not qualify if:

• Patients currently using non-steroidal anti-inflammatory drugs, corticosteroids and mast cell stabilizers, or topical or systemic antibiotics in the past 1 month.
• Patients with major abdominal surgery, a history of inflammatory bowel disease or diverticular disease, celiac disease (by detection of anti-transglutaminase and anti-endomysial antibodies), allergic diseases, including asthma (excluded by family and personal history and specific anti-IgE antibodies), and other organic or psychiatric disorders as assessed by medical history, appropriate consultations and laboratory tests.
• Females who are Pregnant, breast-feeding, or not using reliable methods of contraception

Sponsors & Collaborators

• Next Gen Pharma India Pvt. Ltd.: lead
• Department of Gastroenterology, Govt. Medical College, Kozhikode, Kerala, India: collaborator

Study Sites (1)

Department of Gastroeneterology, Government Medical College

Kozhikode, Kerala, 673008, India

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Shejal A Hanmant, DM Trainee

  Government Medical College, Kozhikide, Kerala, India

  PRINCIPAL INVESTIGATOR

• Varghese Thomas, DM

  Government Medical College, Kozhikide, Kerala, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 10, 2015
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

IN (1)