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Irritable Bowel SyndromePhase 3NCT02545413

Study to Determine Efficacy of Probiotics in Irritable Bowel Syndrome

A Phase 3 study testing Probiotic VSL#3 in people with Irritable Bowel Syndrome, run by Next Gen Pharma India Pvt. Ltd. at 1 site in India.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Probiotic VSL#3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteIndia
Study dates
May 2016to Dec 2017
Phase
Phase 3
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 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Positive diagnoses of IBS subtype IBS-D defined by Rome III criteria, and who meet the following criteria:
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Department of Gastroeneterology, Government Medical College

    Kozhikode, Kerala, 673008

Other trials in India

About this study

Official title: Randomized,Double-blind, Placebo Controlled Trial to Study the Efficacy and Safety of Probiotics in Adult Patients With Irritable Bowel Syndrome-diarrhea Predominant (IBS-D)

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.

Read the detailed description

Irritable bowel syndrome (IBS) is the most common functional GI disorder affecting 10-20% of the population and causing a marked reduction of quality of life in affected individuals. An altered brain-gut axis has been accepted as a main pathogenetic mechanism of IBS, which is associated with a dysfunction of the GI autonomic nervous system. These alterations may lead to abnormal visceral hypersensitivity and aberrations of gut motility. Recently, additional potential mechanisms of IBS have emerged including alteration of gut microbiota and low-grade inflammation/immune activation. These factors might lead to abnormal motility and visceral hypersensitivity and contribute to the symptoms. Naïve gut microbiota plays important roles in the maintenance of gut homeostasis by direct bactericidal effects and the evolution of both innate and adaptive immune systems. Gut microbiota is thought to play important roles in the pathogenesis of IBS. This is evident from the fact that IBS occurs more frequently after intestinal infection or antibiotics treatment. Studies have shown that the alterations of the intestinal microbiota are observed in IBS patients.Considering the relationship between alteration of gut microbiota and inflammation of gut, manipulation of gut microbiota by probiotics appears to be an ideal treatment modality for IBS. However, the beneficial effects and efficacy of altering gut microbiota by probiotics to improve the symptoms of IBS have not been consistent in clinical trials and therefore it remains uncertain as an effective treatment.

Being tested
Probiotic VSL#3, Placebo
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic VSL#3Drug

  • PlaceboDrug

Study groups in NCT02545413
Study groupRoleWhat they receive
ProbioticExperimentalProbiotic 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.
Receives: Drug: Probiotic VSL#3
PlaceboPlacebo comparatorPlacebo 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).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8 wks (after end of treatment)

Secondary outcomes (3)

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

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

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

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

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

    Visceral hypersensitivity/Rectal sensitivity as measured between and within arms using a lubricated rectal balloon catheter for the duration taken for first defecation, first instance of pain and the pain threshold

    Measured: 8 wks (after end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2015 (estimated)
  2. Study startMay 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Why it stopped: Investigator (Dr Amit) not interested to carry out the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02545413
Sponsor's protocol ID
IRC/2015/protocol/24
Status last verified
Mar 2016
First submitted
31 Aug 2015
Last updated
23 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Probiotic VSL#3 in people with Irritable Bowel Syndrome, run by Next Gen Pharma India Pvt. Ltd. at 1 site in India.

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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 23 Mar 2016. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Comparison of the intensity of abdominal pain relief and change in stool consistency before and after treatment, between the two arms (time frame: 8 wks (after end of treatment)). 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 NCT02545413.

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 23 Mar 2016.

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