The Clinical Research Behind Our Formulations

AT MIOME, WE FORMULATE FOR OUTCOMES, NOT MARKETING HYPE.

We believe that if it hasn’t been studied, it shouldn’t be sold. That’s why every product we make is based on clinical results from randomized, placebo-controlled trials in humans — not rodent studies, cell cultures, or artificial gut models. Our lab-to-capsule process translates the latest clinical research into formulations that match the exact dose, delivery form, and capsule dispersion used when benefits were actually demonstrated. From strain selection to delivery mechanism, every decision we make is grounded in real-world evidence, so you get ingredients that truly work for your digestive health.

Our Formulations

We offer two evidence-backed probiotic  formulations – IB-ONE and IB-PRO – each built to match the specific dosing, delivery, and strains used in human clinical trials.

IB-ONE™ 20MG
IB-ONE IB-PRO

B. coagulans Unique IS-2
(2 Billion CFU)

 Probiotic strains

B. coagulans Unique IS-2
(2 Billion CFU)

Lactospore
(2 Billion CFU)

Normal bowel movements

Constipation

Straining

Urgency

Bloating

Gas

Abdominal Pain & Discomfort

 Helps with

Benefits of IB-ONE, with additional support for:

Loose Stools

Nausea

Bloating

Gas
IB-PRO™ 40MG

The Research Behind Unique IS-2

Bacillus coagulans Unique IS-2™, found in both IB-ONE and IB-PRO is a scientifically validated spore-forming probiotic studied in multiple human clinical trials, including 8 focused on digestive health. Some of the most striking evidence comes from studies in IBS and functional constipation populations, where the strain has demonstrated broad spectrum symptom relief.

  • In IBS Populations

    Unique IS-2 (MTCC 5260) has been tested in two randomized, placebo-controlled trials on individuals with diverse IBS subtypes - adults with IBS (n=108)1 and children with IBS (n=141)2

    • 85-93% of participants experienced ≥50% reduction in abdominal pain 1,2
    • Significant improvements in abdominal pain, bloating, flatulence, and bowel habits (urgency, straining)1,2
    • Effective across diverse IBS subtype populations 1,2

    For a comprehensive analysis of Unique IS-2 in IBS written by our lead formulator, Bailey Hanna, MS, RDN, visit ibsprobiotics.org/unique-IS-2

  • In Functional Constipation

    Unique IS-2 (MTCC 5260) tested in a double-blind, placebo-controlled trial (2019)3 – 100 adults over four weeks.

    From 1 to 6 Bowel Movements Per Week

    Baseline to End of Treatment (Week 4)
    • Spontaneous Bowel Movements (SBMs) increased 
 from 0.90 → 5.98 per week 3
    • 98% of participants achieved normal stool consistency 3
    • Significant reductions in incomplete evacuation and painful defecation 3
    • Week 3 & Week 4: Significant improvement over placebo (p < 0.001) 3

Systematic Reviews & Meta-Analyses in IBS

Four recent strain-specific reviews on probiotics in IBS identified B. coagulans Unique IS-2 as a top performer among probiotics:

  • Ranked highest for symptom relief, global symptoms, and straining.

    Efficacy of Probiotics for Irritable Bowel Syndrome: A Systematic Review and Network Meta-Analysis (2022 – 43 RCTs, 5,531 patients)4

  • One of only four probiotics significantly improving global IBS symptoms and abdominal pain.

    Probiotics in Irritable Bowel Syndrome and Inflammatory Bowel Disease: 
 Review of Mechanisms and Effectiveness (2023)5

  • Significantly reduced abdominal pain (RR: 4.9, 95% CI: 3.3–7.3).

    Strain-Specific and Outcome-Specific Efficacy of Probiotics for the Treatment of IBS: A Systematic Review & Meta-Analysis (2021 – 42 RCTs, 3,856 patients)6

  • The most effective probiotic for IBS relief (alongside B. coagulans MTCC 5856), outperforming placebo and many other probiotics.

    Outcome-Specific Efficacy of Different Probiotic Strains & Mixtures in IBS: A Systematic Review & Network Meta-Analysis (2023 – 81 RCTs, 9,253 participants)7

Other Unique IS-2 Research

Four recent strain-specific reviews on probiotics in IBS identified B. coagulans Unique IS-2 as a top performer among probiotics:

  • Human Clinical Trials

    Benefits

    Studies

    Digestive Health

    • Venkataraman et al. Probiotics Antimicrob Proteins. 2023
    • Bamola et al. medRxiv. 2021
    • Saneian et al. Gastroenterol Hepatal Bed Bench. 2015
    • Sudha & Bhonagiri. Int J Probiotics Prebiotics. 2012

    Vaginal Health

    • Sudha et al. Indian J Microbiol. 2012

    Sports Health

    • Tarik et al. Eur J Nutr. 2022

    Oral Health

    • Sudha et al. Int J Clin Pediatr Dent. 2020
    • Talwar et al. Nitte Univ J Health Sci. 2017

    Blood Lipids

    • Sudha et al. Benef Microbes. 2011

  • Preclinical Evidence Supporting Safety, Survivability, and Function

    Evidence

    Studies

    Antiproliferative & Antimutagenic Activity

    • Madempudi & Kalle. Nutr Cancer. 2017
    • Solanki et al. Am J Cancer Biol. 2015

    Anti-inflammatory and Immunomodulatory Activity

    • Sudha & Arunasree. Int J Probiotics Prebiotics. 2015
    • Solanki HK, Shah DA, Maheriya PM, Patel CA. Int J Biol Macromol. 2015

    Antimicrobial & Competitive Exclusion Activity

    • Sharifi et al. Egypt J Vet Sci. 2021

    Survival

    • Ahire et al. LWT – Food Sci Technol. 2020

    Anti-diarrheal Activity

    • Solanki et al. Curr Bioact Compd. 2018

    Safety

    • Sudha et al. Int J Probiotics Prebiotics. 2011
    • Sudha et al. Genet Eng Biotechnol J. 2010
    • Upadrasta et al. Genome Announc. 2016

The Research Behind Lactospore

Bacillus coagulans MTCC 5856 (LactoSpore®) is a clinically supported spore-forming probiotic featured in multiple human trials, including studies in IBS-D and functional bloating populations. Across these trials, the strain has demonstrated consistent improvements in stool form, abdominal pain, bloating, and overall digestive comfort.

  • In an IBS-D Population

    Impressive Clinical Study Results

    In a randomized, placebo-controlled trial in individuals with IBS-D8, 90 days of Lactospore (MTCC 5856) supplementation resulted in the following outcomes:

    • 45.1%

      Decrease in Stool Frequency

    • 43%

      Decrease 
in Diarrhea

    • 41.8%

      Reduction in Bloating Symptoms

    • 68.1%

      Reduction in Abdominal Pain Scores

    • Stool form improved from diarrhea (Bristol Type 6) to normal (Type 3)

  • Systematic Reviews & Meta-Analyses in IBS

    Two recent meta-analyses on probiotics in IBS identified Bacillus coagulans MTCC 5856 as a top-performing probiotic for abdominal pain, bloating, and stool form in IBS-D:

    • Ranked #1 for abdominal pain and bloating relief in IBS.


    Efficacy of Probiotics for Managing IBS: A Network Meta-Analysis (2022 – 43 RCTs, 5,531 patients)4

    • Among the most effective probiotics for IBS-related abdominal pain and the top-ranked probiotic for improving stool form in IBS-D.


    Outcome-Specific Efficacy of Probiotic Strains in IBS: A Systematic Review (2023 – 81 RCTs, 9,253 participants)7

    For a comprehensive analysis of Lactospore in IBS written by our lead formulator, Bailey Hanna, MS, RDN, visit ibsprobiotics.org/lactospore

  • In Functional Gas & Bloating

    A randomized, double-blind, placebo-controlled trial investigated the effects of Bacillus coagulans MTCC 5856 (LactoSpore) at 2 billion CFU/day for 4 weeks in adults with functional gas and bloating.9

    Symptom Improvement at End of Treatment

    Symptom

    Mean Score Decrease (%)

    Bloating

    66.8% ↓

    Burping

    65.0% ↓

    Gas (Flatus)

    65.7% ↓

    Indigestion Score

    65.7% ↓

    All improvements were statistically significant compared to placebo.9

  • Other Lactospore Research

    Human Clinical Trials

    Benefits

    Studies

    Gut Microbiota Modulation

    Majeed et al. Medicine (Baltimore). 2023

    Mental Health

    Majeed et al. Food Nutr Res. 2018

    Safety

    Majeed et al. J Clin Toxicol. 2016

    Preclinical Evidence Supporting Safety, Survivability, and Function

    Evidence

    Studies

    Viability in Hot Beverages

    Majeed et al. Food Research International. 2019

    Anti-diarrheal activity

    Majeed et al. International Journal of Pharma and Bio Sciences. 2016

    Blood Lipids

    Majeed et al. International Journal of Food Science & Technology. 2019

Quality Assurance & Testing

Third-party verified for purity & potency

  • Potency

    • CFUs
      PASS

  • Allergens

    • Gluten
      PASS
    • Dairy (Milk & Casein)
      PASS
    • Soy
      PASS

  • Microbiological Contaminants

    • Aerobic Plate Count
      PASS
    • Yeast & Mold
      PASS
    • E. coli - Coliform
      PASS
    • Enterobacteriaceae
      PASS
    • S. aureus
      PASS

  • Heavy Metals

    • Antimony
      PASS
    • Arsenic
      PASS
    • Beryllium
      PASS
    • Cadmium
      PASS
    • Lead
      PASS
    • Mercury
      PASS
    • Nickel
      PASS
    • Selenium
      PASS

References:

  • Madempudi RS, Ahire JJ, Neelamraju J, Tripathi A, Nallabilli N, Shukla R. Randomized clinical trial: the effect of probiotic Bacillus coagulans Unique IS2 vs placebo on the symptoms management of irritable bowel syndrome in adults. Sci Rep. 2019;9:12210. doi:10.1038/s41598-019-48554-x

  • Sudha MR, Jayanthi N, Aasin M, et al. Efficacy of Bacillus coagulans Unique IS2 in treatment of irritable bowel syndrome in children: a double-blind, randomized placebo-controlled study. Benef Microbes. 2018;9(4):563-572. doi:10.3920/BM2017.0129

  • Madempudi RS, Neelamraju J, Ahire JJ, Tripathi A, Nallabilli N. Bacillus coagulans Unique IS2 in constipation: a double-blind, placebo-controlled study. Probiotics Antimicrob Proteins. 2020;12(1):335-342. doi:10.1007/s12602-019-09542-9

  • Zhang T, Zhang C, Zhang J, Sun F, Duan L. Efficacy of probiotics for irritable bowel syndrome: a systematic review and network meta-analysis. Front Cell Infect Microbiol. 2022;12:859967. doi:10.3389/fcimb.2022.859967

  • So D, Quigley EMM, Whelan K. Probiotics in irritable bowel syndrome and inflammatory bowel disease: review of mechanisms and effectiveness. Curr Opin Gastroenterol. 2023;39(2):103-109. doi:10.1097/MOG.0000000000000902

  • McFarland LV, Huang Y, Wang L, Malfertheiner P. Strain-specific and outcome-specific efficacy of probiotics for the treatment of irritable bowel syndrome: a systematic review and meta-analysis. eClinicalMedicine. 2021;41:101154. doi:10.1016/j.eclinm.2021.101154

  • Xie P, Luo M, Deng X, Fan J, Xiong L. Outcome-specific efficacy of different probiotic strains and mixtures in irritable bowel syndrome: a systematic review and network meta-analysis. Nutrients. 2023;15(17):3856. doi:10.3390/nu15173856

  • Majeed M, Nagabhushanam K, Natarajan S, et al. Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea-predominant irritable bowel syndrome: a double-blind randomized placebo-controlled pilot clinical study. Nutr J. 2015;15:21. doi:10.1186/s12937-016-0140-6

  • Majeed M, Nagabhushanam K, Paulose SM, Arumugam S, Mundkur L. The effects of Bacillus coagulans MTCC 5856 on functional gas and bloating in adults: a randomized, double-blind, placebo-controlled study. Medicine (Baltimore). 2023;102(9):e33109. doi:10.1097/MD.0000000000033109