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01
Summary

Bacillus coagulans MTCC 5856 has shown potential in improving symptoms of irritable bowel syndrome (IBS) and IBS combined with major depressive disorder (MDD) through two small randomized, placebo-controlled pilot studies.

Study 1: IBS-D Symptoms (1)

In the first study, adults with diarrhea-predominant IBS (IBS-D) took 2 billion CFU/day of the probiotic for 90 days, alongside standard IBS treatment. The results were impressive:

  • Stool frequency decreased by 45.1% (Cohen’s d = 2.93; p = 0.0031).
  • Bristol stool form improved significantly, from a baseline of 6 (diarrhea) to 3 (normal stool form) by the fourth visit (Cohen’s d = 1.02; p < 0.01).
  • Diarrhea symptoms decreased by 43% (Cohen’s d = 1.30; p = 0.0026).
  • Bloating symptoms reduced by 41.8% (Cohen’s d = 2.19; p = 0.0037).
  • Abdominal pain scores dropped by 68.1% (Cohen’s d = 2.50; p = 0.0001).
  • Overall health and quality of life improved significantly (Cohen’s d = 1.14; p < 0.01).

However, the small sample size and high attrition rates, particularly in the placebo group (27.8% dropout vs. 5.6% in the treatment group), necessitate cautious interpretation. The authors addressed this by imputing missing measurements with those from previous time points (forward carrying), which, while necessary given the small population size, could have influenced the assessment.

Study 2: IBS and MDD Symptoms (2)

In the second study targeting adults with both IBS and MDD, participants received either a placebo or a 2 billion CFU/day dose of B. coagulans MTCC 5856 for 90 days. This study mostly assessed mental health parameters and found the following significant findings:

  • Depression scores on the Hamilton Rating Scale for Depression (HAM-D) decreased from 13.6 to 5.9 (Cohen’s d = 0.92; p = 0.029).
  • Montgomery-Asberg Depression Rating Scale (MADRS) scores improved from 16.3 to 6.0 (Cohen’s d = 0.93; p = 0.031).
  • Center for Epidemiological Studies Depression Scale (CES-D) scores dropped from 19.1 to 8 (Cohen’s d = 0.84; p < 0.01)
  • Other mental health-related parameters, including Clinical Global Impression-Improvement (CGI-I) rating, Clinical Global Impression-Severity (CGI-S) scale, Gastrointestinal Discomfort Questionnaire (GI-DQ), and Modified Epworth Sleepiness Scale (mESS), showed significant improvements (p = 0.01), except for dementia total reaction scoring.

Key Takeaways: 

Together, these studies suggest that B. coagulans MTCC 5856 may have potential for reducing IBS-D symptoms and might offer benefits for patients with concurrent IBS and MDD. While we are cautiously optimistic about this probiotic, future research with larger sample sizes would help to confirm these findings and fully understand this probiotic’s potential. We would like to emphasize that this probiotic should not be misconstrued as an alternative to more validated mental health therapies and medications, and any add-on therapies to conventional treatment for IBS or MDD should always be discussed with your medical provider.

 

Dosing Instructions: 

Potentially Effective Dose(s) 2 billion CFU/day 
Studied Forms Tablets
Suggested Minimum 

Trial Duration

 90 Days

 

References:

  1. 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 15, 21 (2015). https://doi.org/10.1186/s12937-016-0140-6
  2. Majeed M, Nagabhushanam K, Arumugam S, Majeed S, Ali F. Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study. Food Nutr Res. 2018 Jul 4;62. doi: 10.29219/fnr.v62.1218. PMID: 29997457; PMCID: PMC6034030. 
Read More…

Bacillus coagulans MTCC 5856 has shown potential in improving symptoms of irritable bowel syndrome (IBS) and IBS combined with major depressive disorder (MDD) through two small randomized, placebo-controlled pilot studies.

Study 1: IBS-D Symptoms (1)

In the first study, adults with diarrhea-predominant IBS (IBS-D) took 2 billion CFU/day of the probiotic for 90 days, alongside standard IBS treatment. The results were impressive:

  • Stool frequency decreased by 45.1% (Cohen’s d = 2.93; p = 0.0031).
  • Bristol stool form improved significantly, from a baseline of 6 (diarrhea) to 3 (normal stool form) by the fourth visit (Cohen’s d = 1.02; p < 0.01).
  • Diarrhea symptoms decreased by 43% (Cohen’s d = 1.30; p = 0.0026).
  • Bloating symptoms reduced by 41.8% (Cohen’s d = 2.19; p = 0.0037).
  • Abdominal pain scores dropped by 68.1% (Cohen’s d = 2.50; p = 0.0001).
  • Overall health and quality of life improved significantly (Cohen’s d = 1.14; p < 0.01).

However, the small sample size and high attrition rates, particularly in the placebo group (27.8% dropout vs. 5.6% in the treatment group), necessitate cautious interpretation. The authors addressed this by imputing missing measurements with those from previous time points (forward carrying), which, while necessary given the small population size, could have influenced the assessment.

Study 2: IBS and MDD Symptoms (2)

In the second study targeting adults with both IBS and MDD, participants received either a placebo or a 2 billion CFU/day dose of B. coagulans MTCC 5856 for 90 days. This study mostly assessed mental health parameters and found the following significant findings:

  • Depression scores on the Hamilton Rating Scale for Depression (HAM-D) decreased from 13.6 to 5.9 (Cohen’s d = 0.92; p = 0.029).
  • Montgomery-Asberg Depression Rating Scale (MADRS) scores improved from 16.3 to 6.0 (Cohen’s d = 0.93; p = 0.031).
  • Center for Epidemiological Studies Depression Scale (CES-D) scores dropped from 19.1 to 8 (Cohen’s d = 0.84; p < 0.01)
  • Other mental health-related parameters, including Clinical Global Impression-Improvement (CGI-I) rating, Clinical Global Impression-Severity (CGI-S) scale, Gastrointestinal Discomfort Questionnaire (GI-DQ), and Modified Epworth Sleepiness Scale (mESS), showed significant improvements (p = 0.01), except for dementia total reaction scoring.

Key Takeaways: 

Together, these studies suggest that B. coagulans MTCC 5856 may have potential for reducing IBS-D symptoms and might offer benefits for patients with concurrent IBS and MDD. While we are cautiously optimistic about this probiotic, future research with larger sample sizes would help to confirm these findings and fully understand this probiotic’s potential. We would like to emphasize that this probiotic should not be misconstrued as an alternative to more validated mental health therapies and medications, and any add-on therapies to conventional treatment for IBS or MDD should always be discussed with your medical provider.

 

Dosing Instructions: 

Potentially Effective Dose(s) 2 billion CFU/day 
Studied Forms Tablets
Suggested Minimum 

Trial Duration

 90 Days

 

References:

  1. 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 15, 21 (2015). https://doi.org/10.1186/s12937-016-0140-6
  2. Majeed M, Nagabhushanam K, Arumugam S, Majeed S, Ali F. Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study. Food Nutr Res. 2018 Jul 4;62. doi: 10.29219/fnr.v62.1218. PMID: 29997457; PMCID: PMC6034030. 
Read More…
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Bacillus coagulans MTCC 5856 has shown potential in improving symptoms of irritable bowel syndrome (IBS) and IBS combined with major depressive disorder (MDD) through two small randomized, placebo-controlled pilot studies.

Study 1: IBS-D Symptoms (1)

In the first study, adults with diarrhea-predominant IBS (IBS-D) took 2 billion CFU/day of the probiotic for 90 days, alongside standard IBS treatment. The results were impressive:

  • Stool frequency decreased by 45.1% (Cohen’s d = 2.93; p = 0.0031).
  • Bristol stool form improved significantly, from a baseline of 6 (diarrhea) to 3 (normal stool form) by the fourth visit (Cohen’s d = 1.02; p < 0.01).
  • Diarrhea symptoms decreased by 43% (Cohen’s d = 1.30; p = 0.0026).
  • Bloating symptoms reduced by 41.8% (Cohen’s d = 2.19; p = 0.0037).
  • Abdominal pain scores dropped by 68.1% (Cohen’s d = 2.50; p = 0.0001).
  • Overall health and quality of life improved significantly (Cohen’s d = 1.14; p < 0.01).

However, the small sample size and high attrition rates, particularly in the placebo group (27.8% dropout vs. 5.6% in the treatment group), necessitate cautious interpretation. The authors addressed this by imputing missing measurements with those from previous time points (forward carrying), which, while necessary given the small population size, could have influenced the assessment.

Study 2: IBS and MDD Symptoms (2)

In the second study targeting adults with both IBS and MDD, participants received either a placebo or a 2 billion CFU/day dose of B. coagulans MTCC 5856 for 90 days. This study mostly assessed mental health parameters and found the following significant findings:

  • Depression scores on the Hamilton Rating Scale for Depression (HAM-D) decreased from 13.6 to 5.9 (Cohen’s d = 0.92; p = 0.029).
  • Montgomery-Asberg Depression Rating Scale (MADRS) scores improved from 16.3 to 6.0 (Cohen’s d = 0.93; p = 0.031).
  • Center for Epidemiological Studies Depression Scale (CES-D) scores dropped from 19.1 to 8 (Cohen’s d = 0.84; p < 0.01)
  • Other mental health-related parameters, including Clinical Global Impression-Improvement (CGI-I) rating, Clinical Global Impression-Severity (CGI-S) scale, Gastrointestinal Discomfort Questionnaire (GI-DQ), and Modified Epworth Sleepiness Scale (mESS), showed significant improvements (p = 0.01), except for dementia total reaction scoring.

Key Takeaways: 

Together, these studies suggest that B. coagulans MTCC 5856 may have potential for reducing IBS-D symptoms and might offer benefits for patients with concurrent IBS and MDD. While we are cautiously optimistic about this probiotic, future research with larger sample sizes would help to confirm these findings and fully understand this probiotic’s potential. We would like to emphasize that this probiotic should not be misconstrued as an alternative to more validated mental health therapies and medications, and any add-on therapies to conventional treatment for IBS or MDD should always be discussed with your medical provider.

 

Dosing Instructions: 

Potentially Effective Dose(s) 2 billion CFU/day 
Studied Forms Tablets
Suggested Minimum 

Trial Duration

 90 Days

 

References:

  1. 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 15, 21 (2015). https://doi.org/10.1186/s12937-016-0140-6
  2. Majeed M, Nagabhushanam K, Arumugam S, Majeed S, Ali F. Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study. Food Nutr Res. 2018 Jul 4;62. doi: 10.29219/fnr.v62.1218. PMID: 29997457; PMCID: PMC6034030. 
02
Results
Overall evidence quality grade
78%

This probiotic has higher quality studies in IBS populations supporting it. View our evidence evaluation framework to learn how we assess the quality of studies.

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04
Clinical Studies
  • #
  • Study
  • Year
  • Author(s)
  • Journal
  • Reference
  • Daily Dose
  • Duration of Intervention
  • Form
  • Study Design
  • Age
  • Participants
    • Study #1

    • Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study

    • 2015
    • Majeed, M., Nagabhushanam, K., Natarajan, S. et al.

    • Nutr J 15, 21 (2015).

    • https://doi.org/10.1186/s12937-016-0140-6
    • 2 billion CFU
    • 90 days
    • Tablet
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED

    • ADULTS

    • Total ITT: n= 36; PP n=30
      Probiotic ITT/PP: 18;17
      Placebo ITT/PP: 18; 13
    • Study #2

    • Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study

    • 2018
    • Majeed M, Nagabhushanam K, Arumugam S, Majeed S, Ali F.

    • Food Nutr Res. 2018 Jul 4;62.

    • doi: 10.29219/fnr.v62.1218. PMID: 29997457; PMCID: PMC6034030.
    • 2 billion CFU
    • 90 days
    • Tablet
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED

    • ADULTS

    • Total ITT/PP: 40/40
      Probiotic ITT/PP: 20/20
      Placebo ITT/PP: 20/20
05
Findings from studies

#

  • Diarrhea
  • Constipation
  • Bowel Habits
  • Global IBS Symptoms
  • Abdominal Pain / Discomfort
  • Bloating / Distention
  • Gas / Flatulence
  • Nausea / Vomiting
  • Mental Health
  • Quality of Life
  • Miscellaneous Symptoms
  • Subtype Specific Effects
  • Notes

  • Study #1

    • Diarrhea

      • There was a noteworthy 43% reduction in diarrhea among participants, which was statistically significant compared to the placebo group (p=0.0026, Cohen’s d = 1.3). Additionally, there was a substantial 45.1% decrease in symptom scores for stool frequency, also statistically significant when compared to the placebo (p=0.0031).

      • The study also reported significant improvements in stool form, measured using the Bristol Stool Form Scale. Participants’ baseline scores improved from a 6 to a 3 by the fourth visit, with notable improvements starting as early as weeks 2-4 (p<0.01).

    • Constipation

      • No data

    • Bowel Habits

      • No data

    • Global IBS Symptoms

      • For the Physician’s Global Assessment for disease severity (scale ranges from 0 to 10, where 0 indicates ‘very poor’ and 10 indicates ‘excellent’), there was a statistically significant difference between the placebo and active groups on visits 3 and 4 (*p < 0.01), with a Cohen’s d of 1.49.

    • Abdominal Pain / Discomfort

      • The study reported a 68.1% decrease in mean abdominal pain scores, which was statistically significant compared to the placebo group (p=0.0001).

      • Additionally, reductions in gastrointestinal (GI) discomfort were also statistically significant compared to placebo (*p < 0.01 from visits 2 to 4), with a Cohen’s d of 2.5.

    • Bloating / Distention

      • There was a significant 41.8% reduction in bloating symptom scores compared to the placebo group. This decrease was statistically significant (p=0.0037) with a large effect size (Cohen’s d = 2.19), indicating a substantial improvement in bloating symptoms for the participants receiving the treatment.

    • Gas / Flatulence

      • No data

    • Nausea / Vomiting

      • The study found a mean 47% decrease in vomiting scores, which was statistically significant compared to the placebo group (p=0.0013, Cohen’s d = 1.89).

    • Mental Health

      • No data

    • Quality of Life

      • The IBS Quality of Life (QOL) assessment score showed a statistically significant improvement (p < 0.01) when comparing the placebo and active groups.

      • The change in efficacy assessments between the two treatment groups was also significant (p < 0.01) when analyzing the values from their fourth visit, with a Cohen’s d of 1.14.

    • Miscellaneous Symptoms

      • No data

    • Subtype Specific Effects

      • All results in this study were specific to an IBS-D population.

    • Notes

      • No data

  • Study #2

    • Diarrhea

      • No data

    • Constipation

      • No data

    • Bowel Habits

      • No data

    • Global IBS Symptoms

      • No data

    • Abdominal Pain / Discomfort

      • No data

    • Bloating / Distention

      • No data

    • Gas / Flatulence

      • No data

    • Nausea / Vomiting

      • No data

    • Mental Health

      • The study observed significant improvements in various mental health parameters for participants in the probiotic group:

      • HAM-D: Participants had a baseline mean score of 13.6, indicative of mild/moderate depression. By the end of the treatment, the score declined to 5.9, falling out of the depression range (mild depression score = 10-13 points). This improvement was statistically significant compared to both baseline and placebo (Cohen’s d = 0.92; p = 0.029).

      • MADRS: The mean baseline score was 16.3, indicating mild depression. The final mean score was 6.0, within the normal range. This change was statistically significant compared to baseline and placebo (Cohen’s d = 0.93; p = 0.031).

      • CES-D: The mean score at baseline was 19.1, indicative of depression. After probiotic supplementation, the final score dropped to 8, below the 16-point threshold for depression. This improvement was statistically significant compared to baseline and placebo (Cohen’s d = 0.84; p < 0.01).

      • Other mental health-related parameters also showed significant results in the B. coagulans MTCC 5856 group compared to the placebo group (p = 0.01), except for the dementia total reaction scoring. These parameters included:

      • Clinical Global Impression-Improvement rating Scale (CGI-I) Clinical Global Impression Severity rating Scale (CGI-S) Dementia total frequency scale Gastrointestinal Discomfort Questionnaire (GI-DQ) Modified Epworth Sleepiness Scale (mESS)

    • Quality of Life

      • The authors observed a significant improvement in IBS-QOL scores for the probiotic group compared to both baseline and the placebo group. However, there were some inconsistencies in the scoring.

      • The IBS-QOL typically has a score range of 0-100, but the initial scores in both groups were reported as being greater than 100.

      • Additionally, the reference for the questionnaire used in the study did not provide the actual questionnaire, making it difficult to interpret the clinical relevance of these findings. It remains unclear what tool was used or how to accurately assess the results.

    • Miscellaneous Symptoms

      • No data

    • Subtype Specific Effects

      • No data

    • Notes

      • No data