01
Summary

A randomized placebo-controlled trial conducted in Iranian adults with IBS ( n=97 per protocol population) investigated the efficacy of this 4-strain probiotic blend. (1) The blend, consisting of Bifidobacterium animalis subsp. lactis BB-12®, Lactobacillus acidophilus LA-5®, Lactobacillus delbrueckii subsp. bulgaricus LBY-27, and Streptococcus thermophilus STY-31, demonstrated moderate beneficial effects over placebo for symptoms such as incomplete defecation, bloating, and general symptom relief, with a small beneficial effect over placebo observed for abdominal pain.

No IBS subtype-specific analysis was conducted. The dosage regimen described in the study was unclear, but the product purportedly contained 4 billion CFU, which we assumed meant per capsule. Given that two doses were provided daily, we believe the likely dose administered was 8 billion CFU per day. 

Key Takeaway

Based on evidence from one randomized placebo-controlled trial, this 4-strain probiotic, when taken at a daily dose of 8 billion CFU split between two doses and administered over a 4-week period, may help improve symptoms of IBS such as constipation, bloating, global IBS symptoms, and abdominal pain compared to placebo.

Dosing Instructions

Effective Dose(s) 8 billion CFU per day taken in two split doses of 4 billion CFU
Form 1 capsule, twice daily 
Suggested Minimum 

Trial Duration

4 weeks
Side Effects 
  • No severe adverse effects were observed in this study. 
  • There were no statistically significant differences compared to placebo for all reported adverse effects, including heartburn, borborygmi, abdominal pain, and abdominal distention. 

 

 

References:

  1. Jafari E, Vahedi H, Merat S, Momtahen S, Riahi A. Therapeutic effects, tolerability and safety of a multi-strain probiotic in Iranian adults with irritable bowel syndrome and bloating. Arch Iran Med 2014 Jul;17(7):466-70. [doi: 0141707/AIM.003] 
Read More…

A randomized placebo-controlled trial conducted in Iranian adults with IBS ( n=97 per protocol population) investigated the efficacy of this 4-strain probiotic blend. (1) The blend, consisting of Bifidobacterium animalis subsp. lactis BB-12®, Lactobacillus acidophilus LA-5®, Lactobacillus delbrueckii subsp. bulgaricus LBY-27, and Streptococcus thermophilus STY-31, demonstrated moderate beneficial effects over placebo for symptoms such as incomplete defecation, bloating, and general symptom relief, with a small beneficial effect over placebo observed for abdominal pain.

No IBS subtype-specific analysis was conducted. The dosage regimen described in the study was unclear, but the product purportedly contained 4 billion CFU, which we assumed meant per capsule. Given that two doses were provided daily, we believe the likely dose administered was 8 billion CFU per day. 

Key Takeaway

Based on evidence from one randomized placebo-controlled trial, this 4-strain probiotic, when taken at a daily dose of 8 billion CFU split between two doses and administered over a 4-week period, may help improve symptoms of IBS such as constipation, bloating, global IBS symptoms, and abdominal pain compared to placebo.

Dosing Instructions

Effective Dose(s) 8 billion CFU per day taken in two split doses of 4 billion CFU
Form 1 capsule, twice daily 
Suggested Minimum 

Trial Duration

4 weeks
Side Effects 
  • No severe adverse effects were observed in this study. 
  • There were no statistically significant differences compared to placebo for all reported adverse effects, including heartburn, borborygmi, abdominal pain, and abdominal distention. 

 

 

References:

  1. Jafari E, Vahedi H, Merat S, Momtahen S, Riahi A. Therapeutic effects, tolerability and safety of a multi-strain probiotic in Iranian adults with irritable bowel syndrome and bloating. Arch Iran Med 2014 Jul;17(7):466-70. [doi: 0141707/AIM.003] 
Read More…

A randomized placebo-controlled trial conducted in Iranian adults with IBS ( n=97 per protocol population) investigated the efficacy of this 4-strain probiotic blend. (1) The blend, consisting of Bifidobacterium animalis subsp. lactis BB-12®, Lactobacillus acidophilus LA-5®, Lactobacillus delbrueckii subsp. bulgaricus LBY-27, and Streptococcus thermophilus STY-31, demonstrated moderate beneficial effects over placebo for symptoms such as incomplete defecation, bloating, and general symptom relief, with a small beneficial effect over placebo observed for abdominal pain.

No IBS subtype-specific analysis was conducted. The dosage regimen described in the study was unclear, but the product purportedly contained 4 billion CFU, which we assumed meant per capsule. Given that two doses were provided daily, we believe the likely dose administered was 8 billion CFU per day. 

Key Takeaway

Based on evidence from one randomized placebo-controlled trial, this 4-strain probiotic, when taken at a daily dose of 8 billion CFU split between two doses and administered over a 4-week period, may help improve symptoms of IBS such as constipation, bloating, global IBS symptoms, and abdominal pain compared to placebo.

Dosing Instructions

Effective Dose(s) 8 billion CFU per day taken in two split doses of 4 billion CFU
Form 1 capsule, twice daily 
Suggested Minimum 

Trial Duration

4 weeks
Side Effects 
  • No severe adverse effects were observed in this study. 
  • There were no statistically significant differences compared to placebo for all reported adverse effects, including heartburn, borborygmi, abdominal pain, and abdominal distention. 

 

 

References:

  1. Jafari E, Vahedi H, Merat S, Momtahen S, Riahi A. Therapeutic effects, tolerability and safety of a multi-strain probiotic in Iranian adults with irritable bowel syndrome and bloating. Arch Iran Med 2014 Jul;17(7):466-70. [doi: 0141707/AIM.003] 
02
Results
Overall evidence quality grade
81%

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.

03
Patient Handout
#open-labels
#randomized-controlled-trials
#studied-doses
04
Clinical Studies
  • #
  • Study
  • Year
  • Author(s)
  • Journal
  • Reference
  • Daily Dose
  • Duration of Intervention
  • Form
  • Study Design
  • Age
  • Participants
    • Study #1
    • Therapeutic effects, tolerability and safety of a multi-strain probiotic in Iranian adults with irritable bowel syndrome and bloating

    • 2014
    • Jafari E, Vahedi H, Merat S, Momtahen S, Riahi A.
    • Arch Iran Med 2014 Jul;17(7):466-70

    • DOI: 0141707/AIM.003
    • “Minimum potency of 4 billion CFU”
      – we believe this meant 4 billion CFU per capsule, which would amount to a dose of 8 billion CFU/day, but the dose of the test product was not clear
    • 4 weeks
    • Capsule
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED
    • ADULTS

    • ITT,PP (total) n=108,97
      ITT,PP (probiotic) n= 54,51
      ITT,PP (placebo) n= 54,46
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
  • Notes
  • Study #1

    • Diarrhea
      • No data

    • Constipation
      • At week 4, participants in the probiotic group experienced a significant reduction in feelings of incomplete defecation, with scores decreasing by -32.9 (±7.5). In contrast, the placebo group had a mean reduction of -12.6 (±6.3).

      • This difference was statistically significant, favoring the probiotic group (p<0.01; Cohen’s d = 0.77). Furthermore, these positive effects persisted for one month after treatment in the probiotic group, showing continued improvement (p=0.03).

    • Bowel Habits
      • No data

    • Global IBS Symptoms
      • Participants who received the probiotic treatment reported satisfactory relief of general symptoms at a rate 1.8 times higher than those who received the placebo. This difference was statistically significant (p<0.01; Cohen’s h = 0.84).

    • Abdominal Pain / Discomfort
      • Using a 100 mm Visual Analog Scale (VAS) to measure abdominal pain, the probiotic group experienced a mean score reduction of -8.2 mm (95% CI: -12.5 to -3.9 mm). In contrast, the placebo group had a mean reduction of -2.1 mm (95% CI: -5.0 to +0.8 mm).

      • This reduction in the probiotic group was statistically significant compared to the placebo group (p=0.02; Cohen’s d = 0.44). Furthermore, the reductions in abdominal pain persisted one month after treatment ended in the probiotic group (p<0.01).

    • Bloating / Distention
      • Using a 100 mm Visual Analog Scale (VAS), participants in the probiotic group reported a mean score reduction in bloating of -13.0 mm (95% CI: -17.5 to -8.2 mm) at week 4.

      • In comparison, the placebo group had a mean reduction of -3.7 mm (95% CI: -7.1 to -0.2 mm). This improvement in the probiotic group was statistically significant compared to the placebo group (p<0.01, Cohen’s d = 0.61). Additionally, the beneficial effects in the probiotic group persisted one month after treatment ended (p=0.03).

    • Gas / Flatulence
      • No data

    • Nausea / Vomiting
      • No data

    • Mental Health
      • No data

    • Quality of Life
      • No data

    • Miscellaneous Symptoms
      • No data

    • Notes
      • No data

#open-labels
#randomized-controlled-trials
#studied-doses