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Irritable Bowel SyndromePhase 214PIHLNCT02213172

Evaluation of the Efficacy of Two Probiotic Strains for Irritable Bowel Syndrome

A Phase 2 study testing Bifidobacterium longum R0175 and Lactobacillus paracasei HA-196 in people with Irritable Bowel Syndrome, run by KGK Science Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if two different probiotic strains, Lactobacillus paracasei HA-196 and Bifidobacterium longum R0175, are effective in helping subjects manage the symptoms of IBS Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Bifidobacterium longum R0175 and Lactobacillus paracasei HA-196
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
1 siteCanada
Study dates
30 Oct 2014to Mar 2018
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female aged 18 years and older.
  • IBS diagnosis according to Rome III criteria and referral to this study by a clinician. That is, recurrent abdominal pain or discomfort (i.e., uncomfortable sensation other than pain) at least 2 days/month in the last 3 months (response to question 1 of the IBS Rome III module questionnaire > 2) associated with 2 or more of the following:
  • Improvement with defecation (response to question 4 of the IBS Rome III module questionnaire > 0);
  • Onset associated with a change in stool frequency (response to question 5 or 6 of the IBS Rome III module questionnaire > 0);
  • Onset associated with a change in stool form (appearance). (response to question 7 or 8 of the IBS Rome III module questionnaire > 0).
  • For women, the abdominal pain or discomfort should be experienced during days other than menstrual bleeding (response to question 2 of the IBS Rome III module questionnaire = 0 or 2)
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  • Criterion must be fulfilled for the last 3 months with symptom onset at least 6 months prior to screening (response to question 3 of the IBS Rome III module questionnaire = 1).
  • A copy of the IBS module is provided in Appendix A: IBS Rome III Module Questionnaire
  • Participants from the general population who have IBS symptoms, without a previous diagnosis, will be assessed by the Principle Investigator and included in the study if differential diagnosis confirms IBS. The Principle Investigator will confirm the diagnosis of IBS in any potential participants who have a previous diagnosis of IBS.
  • Subjects experiencing a pain/discomfort frequency of at least 2 days a week during the run-in period. At visit 2, subjects will be asked "In the last 2 weeks, how often each week did you have discomfort or pain anywhere in your abdomen? ". The answer must be at least 2.
  • Subjects diagnosed with IBS who have depression may be included
  • Absence of black color (melena) or blood in stools.
  • Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
  • Willingness to discontinue consumption of probiotics (e.g. yogurts, with live, active cultures or supplements).
  • Able to provide informed consent.

Who cannot join

  • Subjects with a history of suicidal ideation, or current suicidal ideation
  • Previous history of gastrointestinal surgery (except appendectomy, cholecystectomy, hernia repair, or hemorrhoidectomy).
  • Other gastrointestinal diseases (except hemorrhoids and uncomplicated diverticula), as assessed by ultrasonography, colonoscopy, or rectoscopy, or history of Clostridium difficile-associated diarrhea.
  • A family history (immediate family i.e. siblings and parents) of colorectal cancer, inflammatory bowel disease and/or celiac spruce.
  • Co-existing organic gastrointestinal disease.
  • Presence of rectal bleeding, recent weight loss (greater than 5 kg in the past month) or iron deficiency anemia.
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  • History of, or current diagnosis of, liver disease, kidney disease, pulmonary disease, cardiovascular disease, pancreatic disease, any cancer.
  • Presence of immune-compromised conditions such as AIDS, lymphoma or undergoing long-term corticosteroid treatment
  • Presence or history of neurological disorders, or significant psychiatric illness.
  • History of, or current diagnosis of, pelvic floor dyssynergia.
  • Positive drug or alcohol screen or recent history of drug or alcohol abuse (within 3 years of screening).
  • Milk or soy allergy.
  • Use of another investigational product within 3 months of the screening visit. The screened participant could be eligible to participate after a washout period.
  • Positive pregnancy test in women of child-bearing potential.
  • Pregnant or breast-feeding or planning on becoming pregnant.
  • Women of child-bearing potential not using effective contraception. Acceptable methods of birth control include:
  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Intrauterine devices
  • Vasectomy of partner (shown successful as per appropriate follow-up)
  • Double barrier method (use of physical barrier by both partners)
  • Use of any antibiotic drug (e.g., neomycin, rifaximin) within 1 month of screening. The screened participant could be eligible to participate after a 1 month washout period.
  • Use of PPI or H2R antagonist within 1 month of screening. The screened participant could be eligible to participate after a 1 month washout period.
  • Daily use of non-steroidal anti-inflammatory drugs, cortisone, or other anti-inflammatory drugs 1 month prior to screening. The screened participant could be eligible to participate after a 1 month washout period.
  • Current use, or use within the past 1 month, of narcotics or other medications for IBS symptom management (e.g. alosetron, tegaserod, lubiprostone, antispasmodics, antidiarrheals, laxatives, antipsychotics, tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRIs)). Subjects taking a stable dose of anti-depressants for at least 30 days with no plan to change dosage during the trial will be eligible for inclusion in the study.
  • Regular use of anti-diarrhea medications and laxatives. Occasional use is permitted prior to screening (≤ than once a month); if current use is >once per month a one month wash out period is needed prior to screening.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Synergize Inc.

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: Evaluation of the Efficacy of Two Probiotic Strains for Irritable Bowel Syndrome: an 8-Week, Randomized, Placebo-Controlled Study

The purpose of this study is to determine if two different probiotic strains, Lactobacillus paracasei HA-196 and Bifidobacterium longum R0175, are effective in helping subjects manage the symptoms of IBS

Being tested
Bifidobacterium longum R0175, Lactobacillus paracasei HA-196, Placebo
Keywords
IBS, Probiotic, Constipation, Bifidobacterium longum, Lactobacillus paracasei, Lallemand Health Solutions
Medical subject headings
Irritable Bowel Syndrome, Constipation

What participants receive

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

  • Bifidobacterium longum R0175Dietary supplement

  • Lactobacillus paracasei HA-196Dietary supplement

  • PlaceboOther

Study groups in NCT02213172
Study groupRoleWhat they receive
Bifidobacterium longum R0175Experimental10 x 10^9 CFU per capsule, 1 capsule daily for 8 weeks
Receives: Dietary Supplement: Bifidobacterium longum R0175
Lactobacillus paracasei HA-196Experimental10 x 10^9 CFU per capsule, 1 capsule daily for 8 weeks
Receives: Dietary Supplement: Lactobacillus paracasei HA-196
PlaceboPlacebo comparator1 capsule daily for 8 weeks
Receives: Other: Placebo

What is being measured

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

  1. IBS Symptom Severity Score

    Assessed using IBS Severity Scoring System Questionnaire, Part I.

    Measured: 8 Weeks

Secondary outcomes (13)

  1. IBS Symptom Severity Score by IBS Subtype

    Assessed using IBS Severity Scoring System Questionnaire, Part I.

    Measured: 8 weeks

  2. Number of Responders

    A responder is defined as a participant who has at least a 20% improvement in the IBS-SSS severity score after 8 weeks of supplementation

    Measured: 8 weeks

  3. Anxiety and Depression

    Assessed by administering the HADS questionnaire

    Measured: 8 weeks

  4. Abdominal pain frequency

    Assessed using IBS Severity Scoring System Questionnaire, Part I(c)

    Measured: 8 weeks

  5. Abdominal distension/tightness

    Assessed using the IBS-SSS Question 2(b)

    Measured: 8 weeks

  6. Abdominal Pain Intensity

    Mean weekly score. Assessed using IBS-SSS

    Measured: 8 weeks

  7. Severity of straining

    Assessed using IBS daily diary, 5 point ordinal scale

    Measured: 8 weeks

  8. Health Status

    Assessed by administration of the SF-36 questionnaire

    Measured: 8 weeks

  9. Impact of IBS symptoms on Quality of Life

    Assessed by administration of the IBS-QOL Questionnaire

    Measured: 8 weeks

  10. Severity of IBS Symptoms

    Assessed by administration of the IBS-SSS questionnaire, difference from baseline to week 4

    Measured: 4 weeks

  11. Bowel Habit Satisfaction

    Assessed by question 3 of the IBS-SSS

    Measured: 8 weeks

  12. Stool Consistency

    Assessed using the Bristol Stool Scale included in the IBS Daily Diary

    Measured: 8 weeks

  13. Stool Frequency

    Assessed using the IBS Daily Diary

    Measured: 8 weeks

Timeline

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

  1. First posted11 Aug 2014 (estimated)
  2. Study start30 Oct 2014
  3. Primary completion15 Feb 2018
  4. Study completionMar 2018

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213172
Sponsor's protocol ID
14PIHL
Acronym
14PIHL
Status last verified
Mar 2020
First submitted
7 Aug 2014
Last updated
13 Mar 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bifidobacterium longum R0175 and Lactobacillus paracasei HA-196 in people with Irritable Bowel Syndrome, run by KGK Science Inc. at 1 site in Canada.

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 15 inclusion and 25 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: finished, as of the sponsor's last update on 13 Mar 2020. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

IBS Symptom Severity Score (time frame: 8 Weeks). 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 NCT02213172.

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 13 Mar 2020.

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