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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02213172
• Date of registration: 07/08/2014
• Prospective Registration: Yes
• Primary sponsor: KGK Science Inc.
• Public title: Evaluation of the Efficacy of Two Probiotic Strains for Irritable Bowel Syndrome 14PIHL
• Scientific title: Evaluation of the Efficacy of Two Probiotic Strains for Irritable Bowel Syndrome: an 8-Week, Randomized, Placebo-Controlled Study
• Date of first enrolment: October 30, 2014
• Target sample size: 285
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02213172
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Tetyana Pelipyagina, MD
• Affiliation: KGK Science Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Dietary Supplement: Bifidobacterium longum R0175

Other: Placebo

Dietary Supplement: Lactobacillus paracasei HA-196

Primary Outcome(s)

IBS Symptom Severity Score [Time Frame: 8 Weeks]

Secondary Outcome(s)

Severity of straining [Time Frame: 8 weeks]

Abdominal Pain Intensity [Time Frame: 8 weeks]

Anxiety and Depression [Time Frame: 8 weeks]

IBS Symptom Severity Score by IBS Subtype [Time Frame: 8 weeks]

Impact of IBS symptoms on Quality of Life [Time Frame: 8 weeks]

Stool Consistency [Time Frame: 8 weeks]

Number of Responders [Time Frame: 8 weeks]

Stool Frequency [Time Frame: 8 weeks]

Bowel Habit Satisfaction [Time Frame: 8 weeks]

Abdominal pain frequency [Time Frame: 8 weeks]

Severity of IBS Symptoms [Time Frame: 4 weeks]

Health Status [Time Frame: 8 weeks]

Abdominal distension/tightness [Time Frame: 8 weeks]

Secondary ID(s)

14PIHL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lallemand Health Solutions