Clinical trial NCT02950012: A Study to Evaluate OPTI-BIOME™ Bacillus Subtilis MB40 on Abdominal Discomfort, Gas and Bloating in a Healthy Population
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bloating
Keywords: Healthy
Bloating
Abdominal Discomfort
Gas
Probiotic
Bacillus Subtillis
Lead sponsor: BIO-CAT, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2016-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Weekly mean of the daily bloating scores
timeFrame: 4 weeks
Secondary outcomes:
measure: Weekly mean of the daily gas score (flatulence)
timeFrame: 4 weeks
measure: Weekly mean of the abdominal pain score
timeFrame: 4 weeks
measure: Modified Gastrointestinal Symptom Rating Scale (GSRS) score
timeFrame: 4 weeks
measure: Weekly mean stool consistency scores
timeFrame: 4 weeks
measure: Weekly mean number of bowel movements
timeFrame: 4 weeks
measure: Quality of Life
timeFrame: 4 weeks
Other outcomes:
measure: Incidence of clinically significant abnormal vital signs
timeFrame: 4 weeks
measure: Incidence of clinically significant abnormal complete blood panel
timeFrame: 4 weeks
measure: Incidence of clinically significant abnormal electrolytes
timeFrame: 4 weeks
measure: Incidence of clinically significant abnormal kidney function panel
timeFrame: 4 weeks
measure: Incidence of clinically significant abnormal liver function panel
timeFrame: 4 weeks
measure: Incidence of adverse events
timeFrame: 4 weeks
Locations:
city: Foothill Ranch
country: United States
facility: KGK Clinical Trials Center
state: California
city: Orlando
country: United States
facility: KGK Clinical Trials Center
state: Florida
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD'
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penet C, Kramer R, Little R, Spears JL, Parker J, Iyer JK, Guthrie N, Evans M. A Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Efficacy of Bacillus subtilis MB40 to Reduce Abdominal Discomfort, Gas, and Bloating. Altern Ther Health Med. 2021 Jun;27(S1):146-157.