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

Phase 2

Completed

• Conditions: Bloating
• Interventions: Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40; Other: Placebo

• Registration Number: NCT02950012
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-10-31
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPTI-BIOME™ Bacillus subtilis MB40	OPTI-BIOME™ Bacillus subtilis MB40	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Weekly mean of the daily bloating scores	4 weeks	Discomfort, Gas and Bloating questionnaire

Secondary Outcome Measures

Name	Time	Method
Weekly mean of the daily gas score (flatulence)	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
Weekly mean of the abdominal pain score	4 weeks	Discomfort, Gas and Bloating questionnaire
Quality of Life	4 weeks	Rand SF-36

Trial Locations

Locations (2)

KGK Synergize Inc.; 🇨🇦 London, Ontario, Canada

KGK Clinical Trials Center; 🇺🇸 Orlando, Florida, United States