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Evaluation of the Efficacy of Two Probiotic Strains for Irritable Bowel Syndrome (14PIHL)

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ClinicalTrials.gov Identifier: NCT02213172
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
KGK Science Inc.

Tracking Information
First Submitted Date  ICMJE August 7, 2014
First Posted Date  ICMJE August 11, 2014
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE October 30, 2014
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
IBS Symptom Severity Score [ Time Frame: 8 Weeks ]
Assessed using IBS Severity Scoring System Questionnaire, Part I.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
Number of Overall Responders (FDA endpoint) [ Time Frame: 8 Weeks ]
Overall Responder as defined by the FDA Guidance for Industry, Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment, May 2012. A participant is categorized as an overall responder if they achieve (i) a decrease in the weekly average of worst abdominal pain in the past 24 hours score (measured daily) of at least 30 percent compared with baseline weekly average and (ii) an increase of at least one complete spontaneous bowel movement per week from baseline; during the same week, for at least 4 out of the 8 weeks of the intervention period.
Change History Complete list of historical versions of study NCT02213172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • IBS Symptom Severity Score by IBS Subtype [ Time Frame: 8 weeks ]
    Assessed using IBS Severity Scoring System Questionnaire, Part I.
  • Number of Responders [ Time Frame: 8 weeks ]
    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
  • Anxiety and Depression [ Time Frame: 8 weeks ]
    Assessed by administering the HADS questionnaire
  • Abdominal pain frequency [ Time Frame: 8 weeks ]
    Assessed using IBS Severity Scoring System Questionnaire, Part I(c)
  • Abdominal distension/tightness [ Time Frame: 8 weeks ]
    Assessed using the IBS-SSS Question 2(b)
  • Abdominal Pain Intensity [ Time Frame: 8 weeks ]
    Mean weekly score. Assessed using IBS-SSS
  • Severity of straining [ Time Frame: 8 weeks ]
    Assessed using IBS daily diary, 5 point ordinal scale
  • Health Status [ Time Frame: 8 weeks ]
    Assessed by administration of the SF-36 questionnaire
  • Impact of IBS symptoms on Quality of Life [ Time Frame: 8 weeks ]
    Assessed by administration of the IBS-QOL Questionnaire
  • Severity of IBS Symptoms [ Time Frame: 4 weeks ]
    Assessed by administration of the IBS-SSS questionnaire, difference from baseline to week 4
  • Bowel Habit Satisfaction [ Time Frame: 8 weeks ]
    Assessed by question 3 of the IBS-SSS
  • Stool Consistency [ Time Frame: 8 weeks ]
    Assessed using the Bristol Stool Scale included in the IBS Daily Diary
  • Stool Frequency [ Time Frame: 8 weeks ]
    Assessed using the IBS Daily Diary
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • Number of Weekly Responders [ Time Frame: 8 weeks ]
    Weekly Responder as defined by the FDA Guidance for Industry, Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment, May 2012. A participant is categorized as a weekly responder if they achieve (i) a decrease in the weekly average of worst abdominal pain in the past 24 hours score (measured daily) of at least 30 percent compared with baseline weekly average and (ii) an increase of at least one complete spontaneous bowel movement per week from baseline
  • Worst abdominal pain [ Time Frame: 8 weeks ]
    Mean weekly score. Assessed using IBS daily diary, 11 point rating scale
  • Abdominal discomfort [ Time Frame: 8 weeks ]
    Mean weekly score. Assessed using IBS daily diary, 11 point rating scale
  • Abdominal bloating [ Time Frame: 8 weeks ]
    Mean weekly score. Assessed using IBS daily diary, 11 point rating scale
  • Abdominal fullness [ Time Frame: 8 weeks ]
    Mean weekly score. Assessed using IBS daily diary, 11 point rating scale
  • Abdominal cramping [ Time Frame: 8 weeks ]
    Mean weekly score. Assessed using IBS daily diary, 11 point rating scale
  • Severity of straining [ Time Frame: 8 weeks ]
    Assessed using IBS daily diary, 5 point ordinal scale
  • Health Status [ Time Frame: 8 weeks ]
    Assessed by administration of the SF-36 questionnaire
  • Impact of IBS symptoms on Quality of Life [ Time Frame: 8 weeks ]
    Assessed by administration of the IBS-QOL Questionnaire
  • Severity of IBS Symptoms [ Time Frame: 8 weeks ]
    Assessed by administration of the IBS-SSS questionnaire
  • Anxiety and Depression [ Time Frame: 8 weeks ]
    Assessed by administration of the HADS questionnaire
  • Stool Consistency [ Time Frame: 8 weeks ]
    Assessed using the Bristol Stool Scale included in the IBS Daily Diary
  • Stool Frequency [ Time Frame: 8 weeks ]
    Assessed using the IBS Daily Diary
Current Other Pre-specified Outcome Measures
 (submitted: August 25, 2016)
  • Compliance and Recovery of Probiotic strains [ Time Frame: 8 weeks ]
    Monitored by qPCR of fecal samples
  • Microbiome Composition [ Time Frame: 8 weeks ]
    Detected in fecal samples
  • Cysteine and serine-protease activity [ Time Frame: 8 weeks ]
    Measured in stool samples
  • Amount of rescue medication used throughout the trial [ Time Frame: 8 weeks ]
    Use of rescue medication (Bisacodyl 5mg tablet)
  • Safety Anthropometric Measurements [ Time Frame: 8 weeks ]
    Blood pressure, Heart rate, Weight and BMI
  • Safety blood parameters [ Time Frame: 8 weeks ]
    Complete blood count, electrolytes, markers of kidney and liver function
  • Number of Adverse Events occurring throughout the trial [ Time Frame: 8 weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: August 7, 2014)
  • Compliance and Recovery of Probiotic strains [ Time Frame: 8 weeks ]
    Monitored by qPCR of fecal samples
  • Microbiome Composition [ Time Frame: 8 weeks ]
    Detected in fecal samples
  • Cysteine-protease activity [ Time Frame: 8 weeks ]
    Measured in stool samples
  • Salivary Cortisol Levels [ Time Frame: 8 weeks ]
  • Amount of rescue medication used throughout the trial [ Time Frame: 8 weeks ]
    Use of rescue medication (Bisacodyl 5mg tablet)
  • Safety Anthropometric Measurements [ Time Frame: 8 weeks ]
    Blood pressure, Heart rate, Weight and BMI
  • Safety blood parameters [ Time Frame: 8 weeks ]
    Complete blood count, electrolytes, markers of kidney and liver function
  • Number of Adverse Events occurring throughout the trial [ Time Frame: 8 weeks ]
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy of Two Probiotic Strains for Irritable Bowel Syndrome
Official Title  ICMJE Evaluation of the Efficacy of Two Probiotic Strains for Irritable Bowel Syndrome: an 8-Week, Randomized, Placebo-Controlled Study
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Irritable Bowel Syndrome-Constipation
Intervention  ICMJE
  • Dietary Supplement: Bifidobacterium longum R0175
  • Dietary Supplement: Lactobacillus paracasei HA-196
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Bifidobacterium longum R0175
    10 x 10^9 CFU per capsule, 1 capsule daily for 8 weeks
    Intervention: Dietary Supplement: Bifidobacterium longum R0175
  • Experimental: Lactobacillus paracasei HA-196
    10 x 10^9 CFU per capsule, 1 capsule daily for 8 weeks
    Intervention: Dietary Supplement: Lactobacillus paracasei HA-196
  • Placebo Comparator: Placebo
    1 capsule daily for 8 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2014)
285
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213172
Other Study ID Numbers  ICMJE 14PIHL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KGK Science Inc.
Study Sponsor  ICMJE KGK Science Inc.
Collaborators  ICMJE Lallemand Health Solutions
Investigators  ICMJE
Principal Investigator: Tetyana Pelipyagina, MD KGK Science Inc.
PRS Account KGK Science Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP