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

Sponsor

BIO-CAT Microbials, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02950012

Collaborator

KGK Science Inc. (Industry)

100

Enrollment

Locations

Arms

Duration (Months)

33.3

Patients Per Site

8.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

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 :

Oct 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: OPTI-BIOME™ Bacillus subtilis MB40

Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40

Placebo Comparator: Placebo

Other: Placebo

Outcome Measures

Primary Outcome Measures

Weekly mean of the daily bloating scores [4 weeks]
Discomfort, Gas and Bloating questionnaire

Secondary Outcome Measures

Weekly mean of the daily gas score (flatulence) [4 weeks]
Discomfort, Gas and Bloating questionnaire
Weekly mean of the abdominal pain score [4 weeks]
Discomfort, Gas and Bloating questionnaire
Modified Gastrointestinal Symptom Rating Scale (GSRS) score [4 weeks]
Weekly mean stool consistency scores [4 weeks]
Bristol stool scale
Weekly mean number of bowel movements [4 weeks]
Daily Bowel Habits Diary
Quality of Life [4 weeks]
Rand SF-36

Other Outcome Measures

Incidence of clinically significant abnormal vital signs [4 weeks]
Incidence of clinically significant abnormal complete blood panel [4 weeks]
Incidence of clinically significant abnormal electrolytes [4 weeks]
Incidence of clinically significant abnormal kidney function panel [4 weeks]
Incidence of clinically significant abnormal liver function panel [4 weeks]
Incidence of adverse events [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female 18-75 years (inclusive) of age
BMI 18.5-29.9 ±1 kg/m2
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)
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.

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)

Healthy as determined by laboratory results, medical history, and physical exam
Agrees to abstain from consuming unpasteurized bacteria-fermented foods including cheese and yogurt for 1 week prior to screening visit and throughout the study
Agrees to abstain from using fiber supplements 2 weeks prior to screening and for the duration of the study
Agrees to maintain current dietary habits and activity/training levels for two weeks prior to baseline and for the course of the study
Agrees to avoid probiotics for one week prior to screening and for the course of the study
Willingness to complete all the study requirements and attend all clinic visits.
Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

Females who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
History of chronic inflammation or structural abnormality of the digestive tract (inflammatory bowel disease, duodenal or gastric ulcer, intestinal obstruction, or symptomatic cholelithiasis)
Nocturnal and/or progressive abdominal pain (abdominal pain that increases in intensity and is consistent on regular basis)
Significant weight loss over the past 3 months (significance to be determined by the Qualified Investigator)
Type 1 and type 2 diabetes
History of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, or colostomy
Cancer except skin cancers completed excised with no chemotherapy or radiation following and with a negative follow up.
Diagnosis of adenomatous polyposis, irritable bowel syndrome, chronic gastritis or functional dyspepsia, crohn disease, and celiac disease Renal or hepatic insufficiency
Gastrointestinal bleeding or acute infection
Immunodeficiency
History of organ transplant
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
Use of immunosuppressant drugs
Change in anti-psychotic medication within 3 months of randomization
Abdominal surgery within 6 months of randomization
Plan to donate blood during the study or within 30 days of completing the study
Participation in a clinical research trial within 30 days prior to randomization
Allergy or sensitivity to study supplement or placebo ingredients
Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the last 6 months
Use of Medicinal Marijuana
Cognitively impaired and/or unable to give informed consent
Unstable medical conditions
Clinically significant abnormal laboratory results at screening
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KGK Clinical Trials Center	Foothill Ranch	California	United States	92610
2	KGK Clinical Trials Center	Orlando	Florida	United States	32806
3	KGK Synergize Inc.	London	Ontario	Canada	N6A5R8