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A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02950012
Recruitment Status : Unknown
Verified December 2016 by Dr. Tetyana Pelipyagina, BIO-CAT Microbials, LLC.
Recruitment status was:  Recruiting
First Posted : October 31, 2016
Last Update Posted : December 23, 2016
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Dr. Tetyana Pelipyagina, BIO-CAT Microbials, LLC

Brief Summary:
The purpose of this study is to investigate the effects of OPTI-BIOME™ (Bacillus subtilis MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in otherwise healthy adults.

Condition or disease Intervention/treatment Phase
Bloating Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
Study Start Date : October 2016
Estimated Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OPTI-BIOME™ Bacillus subtilis MB40 Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40
Placebo Comparator: Placebo Other: Placebo



Primary Outcome Measures :
  1. Weekly mean of the daily bloating scores [ Time Frame: 4 weeks ]
    Discomfort, Gas and Bloating questionnaire


Secondary Outcome Measures :
  1. Weekly mean of the daily gas score (flatulence) [ Time Frame: 4 weeks ]
    Discomfort, Gas and Bloating questionnaire

  2. Weekly mean of the abdominal pain score [ Time Frame: 4 weeks ]
    Discomfort, Gas and Bloating questionnaire

  3. Modified Gastrointestinal Symptom Rating Scale (GSRS) score [ Time Frame: 4 weeks ]
  4. Weekly mean stool consistency scores [ Time Frame: 4 weeks ]
    Bristol stool scale

  5. Weekly mean number of bowel movements [ Time Frame: 4 weeks ]
    Daily Bowel Habits Diary

  6. Quality of Life [ Time Frame: 4 weeks ]
    Rand SF-36


Other Outcome Measures:
  1. Incidence of clinically significant abnormal vital signs [ Time Frame: 4 weeks ]
  2. Incidence of clinically significant abnormal complete blood panel [ Time Frame: 4 weeks ]
  3. Incidence of clinically significant abnormal electrolytes [ Time Frame: 4 weeks ]
  4. Incidence of clinically significant abnormal kidney function panel [ Time Frame: 4 weeks ]
  5. Incidence of clinically significant abnormal liver function panel [ Time Frame: 4 weeks ]
  6. Incidence of adverse events [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female 18-75 years (inclusive) of age
  2. BMI 18.5-29.9 ±1 kg/m2
  3. Abdominal bloating intensity score ≥5 and at least two days of bloating over the 2 weeks prior to screening (assessed at screening by Abdominal Bloating questionnaire)
  4. Participants categorized as 'high bloaters' as defined by an average bloating score ≥ 5 during the run-in period assessed at baseline by question 3 of the Modified Daily Abdominal Discomfort, Gas, and Bloating Questionnaire, AND/OR, participants categorized as 'high frequency bloaters' as defined by greater than 7 days of high bloating (defined above) during the run-in period.

    • For females, this should not include abdominal discomfort or bloating experienced during menstruation, if such symptoms occur due to menstrual cycle females should go through another run-in period.
  5. If female, participant is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR

    Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:

    • Hormonal contraceptives (stable for 1 month) including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
    • Double-barrier method
    • Intrauterine devices
    • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
    • Vasectomy of partner (shown successful as per appropriate follow-up)
  6. Healthy as determined by laboratory results, medical history, and physical exam
  7. Agrees to abstain from consuming unpasteurized bacteria-fermented foods including cheese and yogurt for 1 week prior to screening visit and throughout the study
  8. Agrees to abstain from using fiber supplements 2 weeks prior to screening and for the duration of the study
  9. Agrees to maintain current dietary habits and activity/training levels for two weeks prior to baseline and for the course of the study
  10. Agrees to avoid probiotics for one week prior to screening and for the course of the study
  11. Willingness to complete all the study requirements and attend all clinic visits.
  12. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  1. Females who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
  2. History of chronic inflammation or structural abnormality of the digestive tract (inflammatory bowel disease, duodenal or gastric ulcer, intestinal obstruction, or symptomatic cholelithiasis)
  3. Nocturnal and/or progressive abdominal pain (abdominal pain that increases in intensity and is consistent on regular basis)
  4. Significant weight loss over the past 3 months (significance to be determined by the Qualified Investigator)
  5. Type 1 and type 2 diabetes
  6. History of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, or colostomy
  7. Cancer except skin cancers completed excised with no chemotherapy or radiation following and with a negative follow up.
  8. Diagnosis of adenomatous polyposis, irritable bowel syndrome, chronic gastritis or functional dyspepsia, crohn disease, and celiac disease Renal or hepatic insufficiency
  9. Gastrointestinal bleeding or acute infection
  10. Immunodeficiency
  11. History of organ transplant
  12. Use of antibiotics within 4 weeks of randomization Routine (at least 3 times per week) consumption of probiotic or prebiotic supplements or supplemented foods and are unwilling to stop at least one week prior to screening and throughout the study
  13. Use of immunosuppressant drugs
  14. Change in anti-psychotic medication within 3 months of randomization
  15. Abdominal surgery within 6 months of randomization
  16. Plan to donate blood during the study or within 30 days of completing the study
  17. Participation in a clinical research trial within 30 days prior to randomization
  18. Allergy or sensitivity to study supplement or placebo ingredients
  19. Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the last 6 months
  20. Use of Medicinal Marijuana
  21. Cognitively impaired and/or unable to give informed consent
  22. Unstable medical conditions
  23. Clinically significant abnormal laboratory results at screening
  24. Any other condition which in the Qualified Investigator's opinion may adversely affect the volunteer's ability to complete the study or its measures or which may pose significant risk to the volunteer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950012


Contacts
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Contact: Mal Evans, PhD (519) 438-9374 ext 239 mevans@kgksynergize.com

Locations
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United States, California
KGK Clinical Trials Center Recruiting
Foothill Ranch, California, United States, 92610
Contact: Gia Radoias    949-464-4451    gradoias@kgkscience.com   
United States, Florida
KGK Clinical Trials Center Recruiting
Orlando, Florida, United States, 32806
Contact: Debi Wills, NP    407-674-7311    dwills@kgkscience.com   
Canada, Ontario
KGK Synergize Inc. Recruiting
London, Ontario, Canada, N6A5R8
Contact: Mal Evans, PhD    (519) 438-9374 ext 239    mevans@kgksynergize.com   
Sponsors and Collaborators
BIO-CAT Microbials, LLC
KGK Science Inc.
Investigators
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Principal Investigator: Tetyana Pelipyagina, MD' KGK Science Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Tetyana Pelipyagina, Principal Investigator, BIO-CAT Microbials, LLC
ClinicalTrials.gov Identifier: NCT02950012    
Other Study ID Numbers: 16OBHB
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Tetyana Pelipyagina, BIO-CAT Microbials, LLC:
Healthy
Bloating
Abdominal Discomfort
Gas
Probiotic
Bacillus Subtillis