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

• ClinicalTrials.gov Identifier: NCT02213172
• Recruitment Status: Completed
• First Posted: August 11, 2014
• Last Update Posted: March 13, 2020
• Sponsor: KGK Science Inc.
• Collaborator: Lallemand Health Solutions
• Information provided by (Responsible Party): KGK Science Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Dietary Supplement: Bifidobacterium longum R0175; Dietary Supplement: Lactobacillus paracasei HA-196; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 285 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Evaluation of the Efficacy of Two Probiotic Strains for Irritable Bowel Syndrome: an 8-Week, Randomized, Placebo-Controlled Study
• Actual Study Start Date: October 30, 2014
• Actual Primary Completion Date: February 15, 2018
• Actual Study Completion Date: March 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bifidobacterium longum R0175; 10 x 10^9 CFU per capsule, 1 capsule daily for 8 weeks	Dietary Supplement: Bifidobacterium longum R0175
Experimental: Lactobacillus paracasei HA-196; 10 x 10^9 CFU per capsule, 1 capsule daily for 8 weeks	Dietary Supplement: Lactobacillus paracasei HA-196
Placebo Comparator: Placebo; 1 capsule daily for 8 weeks	Other: Placebo

Outcome Measures

Primary Outcome Measures :

1. IBS Symptom Severity Score [ Time Frame: 8 Weeks ]
   Assessed using IBS Severity Scoring System Questionnaire, Part I.

Secondary Outcome Measures :

1. IBS Symptom Severity Score by IBS Subtype [ Time Frame: 8 weeks ]
   Assessed using IBS Severity Scoring System Questionnaire, Part I.
2. 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
3. Anxiety and Depression [ Time Frame: 8 weeks ]
   Assessed by administering the HADS questionnaire
4. Abdominal pain frequency [ Time Frame: 8 weeks ]
   Assessed using IBS Severity Scoring System Questionnaire, Part I(c)
5. Abdominal distension/tightness [ Time Frame: 8 weeks ]
   Assessed using the IBS-SSS Question 2(b)
6. Abdominal Pain Intensity [ Time Frame: 8 weeks ]
   Mean weekly score. Assessed using IBS-SSS
7. Severity of straining [ Time Frame: 8 weeks ]
   Assessed using IBS daily diary, 5 point ordinal scale
8. Health Status [ Time Frame: 8 weeks ]
   Assessed by administration of the SF-36 questionnaire
9. Impact of IBS symptoms on Quality of Life [ Time Frame: 8 weeks ]
   Assessed by administration of the IBS-QOL Questionnaire
10. Severity of IBS Symptoms [ Time Frame: 4 weeks ]
    Assessed by administration of the IBS-SSS questionnaire, difference from baseline to week 4
11. Bowel Habit Satisfaction [ Time Frame: 8 weeks ]
    Assessed by question 3 of the IBS-SSS
12. Stool Consistency [ Time Frame: 8 weeks ]
    Assessed using the Bristol Stool Scale included in the IBS Daily Diary
13. Stool Frequency [ Time Frame: 8 weeks ]
    Assessed using the IBS Daily Diary

Other Outcome Measures:

1. Compliance and Recovery of Probiotic strains [ Time Frame: 8 weeks ]
   Monitored by qPCR of fecal samples
2. Microbiome Composition [ Time Frame: 8 weeks ]
   Detected in fecal samples
3. Cysteine and serine-protease activity [ Time Frame: 8 weeks ]
   Measured in stool samples
4. Amount of rescue medication used throughout the trial [ Time Frame: 8 weeks ]
   Use of rescue medication (Bisacodyl 5mg tablet)
5. Safety Anthropometric Measurements [ Time Frame: 8 weeks ]
   Blood pressure, Heart rate, Weight and BMI
6. Safety blood parameters [ Time Frame: 8 weeks ]
   Complete blood count, electrolytes, markers of kidney and liver function
7. Number of Adverse Events occurring throughout the trial [ Time Frame: 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Canada, Ontario

KGK Synergize Inc.

London, Ontario, Canada, N6A 5R8

Sponsors and Collaborators

KGK Science Inc.

Lallemand Health Solutions

Investigators

• Principal Investigator: Tetyana Pelipyagina, MD; KGK Science Inc.

More Information

• Responsible Party: KGK Science Inc.
• ClinicalTrials.gov Identifier: NCT02213172
• Other Study ID Numbers: 14PIHL
• First Posted: August 11, 2014
• Last Update Posted: March 13, 2020
• Last Verified: March 2020

Keywords provided by KGK Science Inc.:

IBS; Probiotic; Constipation; Bifidobacterium longum; Lactobacillus paracasei; Lallemand Health Solutions

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases