01
Summary

Two clinical trials aimed to evaluate the effects of a 7-strain probiotic called Dualac7 in individuals with IBS-D (Irritable Bowel Syndrome with Diarrhea). However, both studies were excluded from our analysis due to significant methodological flaws, as outlined below:

 

1st Study: Cha BK, Jung SM, Choi CH, et al. (2011)

 

This study faced several critical issues:

  • Underpowered: The study included too few participants, making it unreliable for detecting significant effects.
  • Questionable Statistics: The study reported statistical differences in percentage changes between groups, a measure that holds little meaningful value. Alarmingly, the differences between the means of three IBS symptoms were identical, raising red flags.
  • Reanalysis Findings: After recalculating the statistics, we discovered discrepancies that undermined the original findings. Our reanalysis showed no statistically significant improvements in abdominal pain or discomfort, though the effect on discomfort was close to significant (p = 0.064; Cohen’s d = 0.54). For global IBS symptoms, we found a moderate but statistically significant effect (p = 0.047; Cohen’s d = 0.59). However, there were no significant effects on other symptoms, such as loose/watery stools. Due to these flaws, this study was disqualified from our database.

 

2nd Study: Ko S, Han G, Kim S, Seo J, et al. (2013)

 

 This study also encountered significant problems:

  • Small Sample Size: Although the study originally included four arms, our focus was on the probiotic plus placebo arm to assess the probiotic’s independent effects. Unfortunately, this arm had only 14 participants, which further decreased to 10 due to attrition, leaving the study severely underpowered.
  • Limited Findings: Our analysis revealed a significant improvement in the ease of stool passage (Cohen’s d = 0.63; p = 0.034). However, no significant changes were observed in other symptoms, including overall IBS symptoms, bowel movement frequency and consistency, abdominal pain, discomfort, bloating, flatulence, urgency, mucus in stool, and overall quality of life. Given the high attrition rate and the severely underpowered nature of the study, it was disqualified from our database.

 

Key Takeaways:

Due to critical methodological flaws, both studies assessing Duolac7 in IBS-D populations were deemed unreliable and were excluded from our analysis. At this time, there is insufficient evidence to recommend the use of this probiotic in IBS populations.

 

Dosing Instructions: 

None


 

References:

  1. Ki Cha B, Mun Jung S, Hwan Choi C, et al. The effect of a multispecies probiotic mixture on the symptoms and fecal microbiota in diarrhea-dominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Gastroenterol. 2012;46(3):220–227. doi: 10.1097/MCG.0b013e31823712b1.

 

  1. Ko SJ, Han G, Kim SK, et al. Effect of Korean herbal medicine combined with a probiotic mixture on diarrhea-dominant irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial. Evid Based Complement Alternat Med. 2013;2013:824605. doi: 10.1155/2013/824605.

 

Read More…

Two clinical trials aimed to evaluate the effects of a 7-strain probiotic called Dualac7 in individuals with IBS-D (Irritable Bowel Syndrome with Diarrhea). However, both studies were excluded from our analysis due to significant methodological flaws, as outlined below:

 

1st Study: Cha BK, Jung SM, Choi CH, et al. (2011)

 

This study faced several critical issues:

  • Underpowered: The study included too few participants, making it unreliable for detecting significant effects.
  • Questionable Statistics: The study reported statistical differences in percentage changes between groups, a measure that holds little meaningful value. Alarmingly, the differences between the means of three IBS symptoms were identical, raising red flags.
  • Reanalysis Findings: After recalculating the statistics, we discovered discrepancies that undermined the original findings. Our reanalysis showed no statistically significant improvements in abdominal pain or discomfort, though the effect on discomfort was close to significant (p = 0.064; Cohen’s d = 0.54). For global IBS symptoms, we found a moderate but statistically significant effect (p = 0.047; Cohen’s d = 0.59). However, there were no significant effects on other symptoms, such as loose/watery stools. Due to these flaws, this study was disqualified from our database.

 

2nd Study: Ko S, Han G, Kim S, Seo J, et al. (2013)

 

 This study also encountered significant problems:

  • Small Sample Size: Although the study originally included four arms, our focus was on the probiotic plus placebo arm to assess the probiotic’s independent effects. Unfortunately, this arm had only 14 participants, which further decreased to 10 due to attrition, leaving the study severely underpowered.
  • Limited Findings: Our analysis revealed a significant improvement in the ease of stool passage (Cohen’s d = 0.63; p = 0.034). However, no significant changes were observed in other symptoms, including overall IBS symptoms, bowel movement frequency and consistency, abdominal pain, discomfort, bloating, flatulence, urgency, mucus in stool, and overall quality of life. Given the high attrition rate and the severely underpowered nature of the study, it was disqualified from our database.

 

Key Takeaways:

Due to critical methodological flaws, both studies assessing Duolac7 in IBS-D populations were deemed unreliable and were excluded from our analysis. At this time, there is insufficient evidence to recommend the use of this probiotic in IBS populations.

 

Dosing Instructions: 

None


 

References:

  1. Ki Cha B, Mun Jung S, Hwan Choi C, et al. The effect of a multispecies probiotic mixture on the symptoms and fecal microbiota in diarrhea-dominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Gastroenterol. 2012;46(3):220–227. doi: 10.1097/MCG.0b013e31823712b1.

 

  1. Ko SJ, Han G, Kim SK, et al. Effect of Korean herbal medicine combined with a probiotic mixture on diarrhea-dominant irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial. Evid Based Complement Alternat Med. 2013;2013:824605. doi: 10.1155/2013/824605.

 

Read More…

Two clinical trials aimed to evaluate the effects of a 7-strain probiotic called Dualac7 in individuals with IBS-D (Irritable Bowel Syndrome with Diarrhea). However, both studies were excluded from our analysis due to significant methodological flaws, as outlined below:

 

1st Study: Cha BK, Jung SM, Choi CH, et al. (2011)

 

This study faced several critical issues:

  • Underpowered: The study included too few participants, making it unreliable for detecting significant effects.
  • Questionable Statistics: The study reported statistical differences in percentage changes between groups, a measure that holds little meaningful value. Alarmingly, the differences between the means of three IBS symptoms were identical, raising red flags.
  • Reanalysis Findings: After recalculating the statistics, we discovered discrepancies that undermined the original findings. Our reanalysis showed no statistically significant improvements in abdominal pain or discomfort, though the effect on discomfort was close to significant (p = 0.064; Cohen’s d = 0.54). For global IBS symptoms, we found a moderate but statistically significant effect (p = 0.047; Cohen’s d = 0.59). However, there were no significant effects on other symptoms, such as loose/watery stools. Due to these flaws, this study was disqualified from our database.

 

2nd Study: Ko S, Han G, Kim S, Seo J, et al. (2013)

 

 This study also encountered significant problems:

  • Small Sample Size: Although the study originally included four arms, our focus was on the probiotic plus placebo arm to assess the probiotic’s independent effects. Unfortunately, this arm had only 14 participants, which further decreased to 10 due to attrition, leaving the study severely underpowered.
  • Limited Findings: Our analysis revealed a significant improvement in the ease of stool passage (Cohen’s d = 0.63; p = 0.034). However, no significant changes were observed in other symptoms, including overall IBS symptoms, bowel movement frequency and consistency, abdominal pain, discomfort, bloating, flatulence, urgency, mucus in stool, and overall quality of life. Given the high attrition rate and the severely underpowered nature of the study, it was disqualified from our database.

 

Key Takeaways:

Due to critical methodological flaws, both studies assessing Duolac7 in IBS-D populations were deemed unreliable and were excluded from our analysis. At this time, there is insufficient evidence to recommend the use of this probiotic in IBS populations.

 

Dosing Instructions: 

None


 

References:

  1. Ki Cha B, Mun Jung S, Hwan Choi C, et al. The effect of a multispecies probiotic mixture on the symptoms and fecal microbiota in diarrhea-dominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Gastroenterol. 2012;46(3):220–227. doi: 10.1097/MCG.0b013e31823712b1.

 

  1. Ko SJ, Han G, Kim SK, et al. Effect of Korean herbal medicine combined with a probiotic mixture on diarrhea-dominant irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial. Evid Based Complement Alternat Med. 2013;2013:824605. doi: 10.1155/2013/824605.

 

02
Results
Overall evidence quality grade
0%

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

03
Patient Handout
04
Clinical Studies
  • #
  • Study
  • Year
  • Author(s)
  • Journal
  • Reference
  • Daily Dose
  • Duration of Intervention
  • Form
  • Study Design
  • Age
  • Participants
    • Study #1
    • The effect of a multispecies probiotic mixture on the symptoms and fecal microbiota in diarrhea-dominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial

    • 2012
    • Ki Cha B, Mun Jung S, Hwan Choi C, et al.
    • J Clin Gastroenterol 2012;46(3):220–7

    • DOI: 10.1097/MCG.0b013e31823712b1
    • 10 billion CFU
    • 8 weeks
    • Capsule
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED
    • ADULTS   18-65 years

    • ITT,PP (total) n= ; 50,47 (probiotic) n= ; 25,24
      ( ITT, PP placebo) n= 25, 23
    • Study #2
    • Effect of Korean herbal medicine combined with a probiotic mixture on diarrhea-dominant irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial

    • 2013
    • Ko SJ, Han G, Kim SK, et al.
    • Alternat Med 2013;2013:824605

    • doi: 10.1155/2013/824605
    • 5 billion CFU
    • 8 weeks
    • Capsule
      • Double-blind
      • randomized
      • placebo-controlled
    • ADULTS    18-65

    • ITT,PP (total) n=53,48
      ITT,PP (GJS plus Probiotic n=13,13
      ITT,PP (GJS plus placebo) n=14,13
      ITT,PP (Probiotic plus placebo) n=14,10
      ITT,PP ( full placebo) n=12,12
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
      • For loose/watery stool, there was a mean % change rate of -35.6± 74.3 in the probiotic group, vs. a -26.6± 58.1 % change rate in the placebo group. This was not a statistically significant change when comparing groups (p=0.65).

      • For urgency, there was a mean % change rate of -45.2± 358.1 in the probiotic group, vs. a -39.9± 75.6 % change rate in the placebo group. This was not a statistically significant change when comparing groups (p= 0.28)

    • Constipation
      • No data

    • Bowel Habits
      • Stool consistency improved significantly in the probiotics group compared with the placebo group, though this contradicts with non-significant results found for loose/watery stool scores (see diarrhea cell for further details).

    • Global IBS Symptoms
      • The proportion of weekly AR for overall symptoms was significantly higher in the probiotics group than in the placebo group throughout the treatment and posttreatment periods (all P< 0.05; Fig. 3). The proportion of responders (AR of overall IBS symptoms for at least 5 of the 10 weekly assessments) was 48% (12 of 25) in the probiotics group and 12% (3 of 25) in the placebo group, and the difference between the 2 groups was statistically significant (P= 0.01).

      • Both groups showed improvement in the mean values of individual symptom scores during the treatment period (33.8% in probiotics and 33.3% in placebo, P< 0.01). However, percentage changes in total mean scores and subscores did not differ significantly between the 2 groups.

      • For total VAS scores, there was a mean % change rate of -33.8± 44.6 in the probiotic group, vs. a -33.3± 34.2% change rate in the placebo group. This was not a statistically significant change when comparing groups (p=0.96).

    • Abdominal Pain / Discomfort
      • For abdominal pain, there was a mean % change rate of -8.3 ± 140.1 in the probiotic group, and a -8.7 ± 84.9 in the placebo group. This was not a statistically significant difference (p=0.62). For abdominal discomfort, there was a mean % change rate of -43.5± 42.4 in the probiotic group, and a change of -31.0± 47.9 in the placebo group. This change was also not statistically significant (p=0.35)

    • Bloating / Distention
      • For bloating, there was a mean % change rate of -20.8± 73.5 in the probiotic group, vs. a -17.7± 81.6% change rate in the placebo group. This was not a statistically significant change when comparing groups (p=0.89).

    • Gas / Flatulence
      • For passage of gas, there was a mean % change rate of -13.6± 71.5 in the probiotic group, vs. a -29.0± 32.2% change rate in the placebo group. This was not a statistically significant change when comparing groups (p=0.35).

    • Nausea / Vomiting
      • No data

    • Mental Health
      • No data

    • Quality of Life
      • The overall %change rates for mean QOL scores were 21.3± 21.6 for the probiotic group vs. 9.0± 21.5 for the placebo group. This was not a statistically significant result when comparing groups (p=0.073).

    • Miscellaneous Symptoms
      • For mucus in stool, there was a mean % change rate of -11.9± 69.3 in the probiotic group, vs. a +62.3± 316.8% change rate in the placebo group. This was not a statistically significant change when comparing groups (p=0.29).

    • Notes
      • No data

  • Study #2

    • Diarrhea
      • There was no statistically significant improvement for bloating scores between the 4 groups (p=0.752)

    • Constipation
      • No data

    • Bowel Habits
      • There were no significant improvements in bowel function scores between the 4 intervention groups. Bowel function scores assessed stool frequency, consistency and ease of passage.

    • Global IBS Symptoms
      • For adequate relief of symptoms, all treatment groups with improvement, no statistically significant difference between all 4 groups (p<0.05); using ITT principle. Compared with GJS-Placebo plus DUO-Placebo: The GSJ plus DUO group, GJS-Placebo plus DUO group, and GJS plus DUO-Placebo group showed statistically significant improvement during 8 weeks of administration period.

      • GJS+DUO p<0.01; GJS=DUO-placebo p=<0.01; GJS placebo + DUO p=<0.05. Only the data for the GJS placebo + DUO group shows an isolated effect of the probiotic absent the effects of the herbal medication.

      • Bowel function scores, individual symptoms (abdominal pain, discomfort, bloating, flatulence, urgency, and mucus in stool), and overall symptoms were improved in all groups after the administration of the study agents.

      • In particular, the ease of passage tended to improve substantially in the GJS+DUO and GJS-P+DUO groups relative to the findings for the other groups, but the improvement was not significant.

    • Abdominal Pain / Discomfort
      • There was no significant improvement in abdominal pain scores or abdominal discomfort scores between the 4 groups at the end of treatment (p=0.947; p=0.945, respectively)

    • Bloating / Distention
      • There was no statistically significant improvement for bloating scores between the 4 groups (p=0.752)

    • Gas / Flatulence
      • There was no statistically significant improvement in flatulence between the 4 groups (p=0.689)

    • Nausea / Vomiting
      • No data

    • Mental Health
      • No data

    • Quality of Life
      • Quality of life improved in all groups after treatment compared to the findings at week 0. However, there were no statistically significant differences among the 4 groups before and after treatment.

      • Moreover, when analyzed by the subcategories of quality of life (dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sex, and relationship), no significant differences among the 4 groups showed

    • Miscellaneous Symptoms
      • There was no statistically significant improvement for mucus in stool scores between the 4 groups (p=0.856)

    • Notes
      • No data