NCT02213172

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

August 7, 2014

Last Update Submit

March 11, 2020

Conditions

Irritable Bowel Syndrome

Keywords

IBSProbioticConstipationBifidobacterium longumLactobacillus paracaseiLallemand Health Solutions

Outcome Measures

Primary Outcomes (1)

  • IBS Symptom Severity Score

    Assessed using IBS Severity Scoring System Questionnaire, Part I.

    8 Weeks

Secondary Outcomes (13)

  • IBS Symptom Severity Score by IBS Subtype

    8 weeks

  • Number of Responders

    8 weeks

  • Anxiety and Depression

    8 weeks

  • Abdominal pain frequency

    8 weeks

  • Abdominal distension/tightness

    8 weeks

  • +8 more secondary outcomes

Other Outcomes (7)

  • Compliance and Recovery of Probiotic strains

    8 weeks

  • Microbiome Composition

    8 weeks

  • Cysteine and serine-protease activity

    8 weeks

  • +4 more other outcomes

Study Arms (3)

Bifidobacterium longum R0175

EXPERIMENTAL

10 x 10\^9 CFU per capsule, 1 capsule daily for 8 weeks

Dietary Supplement: Bifidobacterium longum R0175

Lactobacillus paracasei HA-196

EXPERIMENTAL

10 x 10\^9 CFU per capsule, 1 capsule daily for 8 weeks

Dietary Supplement: Lactobacillus paracasei HA-196

Placebo

PLACEBO COMPARATOR

1 capsule daily for 8 weeks

Other: Placebo

Interventions

Bifidobacterium longum R0175DIETARY_SUPPLEMENT
Bifidobacterium longum R0175
Lactobacillus paracasei HA-196DIETARY_SUPPLEMENT
Lactobacillus paracasei HA-196
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeConstipation

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tetyana Pelipyagina, MD

    KGK Science Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

August 11, 2014

Study Start

October 30, 2014

Primary Completion

February 15, 2018

Study Completion

March 1, 2018

Last Updated

March 13, 2020

Record last verified: 2020-03

Locations

CA(1)