Safety and Tolerability of Bacillus Subtilis MB40 in Healthy Adult Volunteers

NCT04655352 | Completed DMC

• 1 other identifier: BCT-100-000
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-blind, placebo-lead in design examining the safety and tolerability of a probiotic, Bacillus subtilis MB40. Subjects received a 7-day placebo BID lead-in and a 21-day BID course of Bacillus subtilis MB40. GI questionnaires and Bristol stool charts along with evaluation of any medically significant changes, based on physical examination findings, clinical laboratory tests and vital signs assessments were used to determine the safety and tolerability of MB40.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events

  GI Questionnaire and weekly in person assessment of adverse events

  4 weeks

Secondary Outcomes (2)

• Weekly mean of daily frequency of GI symptoms

  4 weeks

• Weekly mean of daily severity of GI symptoms

  4 weeks

Other Outcomes (3)

• Frequency of bowel movements

  4 weeks

• Incidence of clinically significant abnormal vital signs

  Screening and day 29

• Incidence of clinically significant abnormal complete blood panel

  Screening and day 29

Study Arms (1)

Bacillus subtilis MB40

1-week placebo (maltodextrin and excipients) lead-in followed by MB40 intervention

Dietary Supplement: Bacillus subtilis MB40

Interventions

Bacillus subtilis MB40 DIETARY_SUPPLEMENT

1-week placebo (maltodextrin and excipients) lead-in followed by 250 mg capsule (5 billion CFU/capsule) administered twice daily for 21 days

Also known as: OPTI-BIOME MB40

Bacillus subtilis MB40

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Human volunteers meeting eligibility criteria listed above.

You may qualify if:

• Normal, healthy adult volunteers aged 18 to 55 years.
• BMI of 18 to 32 kg/m2 (inclusive)
• Have no clinically significant findings on screening evaluations (clinical, laboratory)
• 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)
• Able to comprehend and willing to sign an Informed Consent Form (ICF).

You may not qualify if:

• History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders.
• Current or recent history (\<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection.
• Frequent GERD, indigestion, nausea, or vomiting (1 or more days per week).
• Frequent abdominal pain/cramps or bloating (1 or more days per week).
• Frequent constipation, diarrhea, or alternating constipation/diarrhea (1 or more days per week).
• Abdominal pain before bowel movements that is relieved with defecation (most bowel movements).
• Abdominal complaints often worsened by worry or tension (1 or more days per week).
• Medical diagnosis of esophagitis, gastritis, ulcers, inflammatory bowel disease, gastrointestinal cancer, celiac disease, or irritable bowel syndrome.
• Recent gastrointestinal bleeding (hematemesis, hematochezia, melena in past 3 months) or anemia in the past 3 months.
• Unintentional weight loss of 10 lbs or more in the past 3 months.
• Screening GI Questionnaire Score of ≥ 4 for any single item.
• Current clinically significant viral infection
• History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
• Resting heart rate less than 45 bpm or greater than 100 bpm.
• History of unstable ischemic heart disease or uncontrolled hypertension (blood pressure \>150/90 mm Hg)

Sponsors & Collaborators

• BIO-CAT Microbials, LLC: lead
• Prism Research LLC: collaborator

Related Publications (1)

• Spears JL, Kramer R, Nikiforov AI, Rihner MO, Lambert EA. Safety Assessment of Bacillus subtilis MB40 for Use in Foods and Dietary Supplements. Nutrients. 2021 Feb 25;13(3):733. doi: 10.3390/nu13030733.

  PMID: 33668992 RESULT

Study Officials

• Mark Matson, MD

  Prism Research LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: October 28, 2015
• Primary Completion: December 17, 2015
• Study Completion: December 17, 2015
• Last Updated: February 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share