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

NCT02950012 | Completed Phase 2

• 1 other identifier: 16OBHB
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

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.

Conditions

Bloating

Keywords

Healthy; Bloating; Abdominal Discomfort; Gas; Probiotic; Bacillus Subtillis

Outcome Measures

Primary Outcomes (1)

• Weekly mean of the daily bloating scores

  Discomfort, Gas and Bloating questionnaire

  4 weeks

Secondary Outcomes (6)

• Weekly mean of the daily gas score (flatulence)

  4 weeks

• Weekly mean of the abdominal pain score

  4 weeks

• Modified Gastrointestinal Symptom Rating Scale (GSRS) score

  4 weeks

• Weekly mean stool consistency scores

  4 weeks

• Weekly mean number of bowel movements

  4 weeks

Other Outcomes (6)

• 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

Study Arms (2)

OPTI-BIOME™ Bacillus subtilis MB40

EXPERIMENTAL

Dietary Supplement: OPTI-BIOME™ Bacillus subtilis MB40

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

OPTI-BIOME™ Bacillus subtilis MB40 DIETARY_SUPPLEMENT

OPTI-BIOME™ Bacillus subtilis MB40

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BIO-CAT Microbials, LLC: lead
• KGK Science Inc.: collaborator

Study Sites (3)

KGK Clinical Trials Center

Foothill Ranch, California, 92610, United States

Location

KGK Clinical Trials Center

Orlando, Florida, 32806, United States

Location

KGK Synergize Inc.

London, Ontario, N6A5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 31719214 DERIVED

MeSH Terms

Conditions

Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tetyana Pelipyagina, MD'

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: October 31, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (2)