01
Summary

Five studies were initially identified that explored the effects of LGG (Lactobacillus rhamnosus GG) in IBS populations. (1,2,3,4,5) However, three of these studies were disqualified from consideration due to significant confounding factors that limited the reliability of their results. (1,2,3)  

  1. Unspecified Inulin Dose as a Major Confounder: Two studies included inulin in both the probiotic and placebo groups, but the exact dose of inulin was not specified. (1,2) This lack of detail makes it unclear what intervention was actually provided, severely complicating the interpretation of the results. Without knowing whether the inulin was provided in equal doses between the treatment and placebo groups, it is impossible to determine if the effects observed were due to LGG, inulin, or a combination of both. Additionally, given that inulin can have varying impacts on individuals with IBS—potentially exacerbating symptoms—this lack of clarity severely limits the interpretation of the results.
  2. Lack of Blinding and Control: Another study compared LGG with a control group and a low FODMAP diet group but lacked blinding, and the control group did not receive a placebo.(3) This flaw made the study unsuitable for inclusion in our analysis, as a placebo control is critical for assessing the true efficacy of a treatment.

Studies Included in our Evaluation

This leaves us with two studies that avoided major confounding factors and included IBS participants:

  • Study 1: The first study included 104 children described as having functional bowel disorders, of which only 37 had IBS. (4) Among the IBS participants, there was a near significant reduction in the frequency of abdominal pain in the LGG group compared to the placebo group (Cohen’s d = 0.62, p = 0.067), though there was no significant difference in pain severity. Treatment success, defined as “no pain,” was reported by 33% of the IBS LGG group versus 5% in the placebo group (p=0.029; Cohen’s h= 0.77). However, these results should be interpreted cautiously due to wide confidence intervals and the lack of baseline severity and frequency data specifically for the IBS participants.
  • Study 2: The second study was conducted in 141 children with IBS or functional abdominal pain, of which 80 participants had IBS. (5) The study noted improvements in both the frequency and intensity of abdominal pain among the IBS participants. At weeks 5-12, 79% of the IBS LGG group achieved treatment success for the number of pain episodes, compared to 45% in the placebo group (p=0.004; Cohen’s d= 0.69). At the 13-20 week follow-up, this increased to 82% for the LGG group and 50% for placebo (p=0.001; Cohen’s h= 0.79). While the intensity of pain episodes did not show significant improvement during weeks 5-12 (p=0.1), by weeks 13-20, 72% of the IBS LGG group reported treatment success for pain intensity, compared to 46% in the placebo group (p=0.029; Cohen’s d = 0.51). This study also observed that LGG led to a significant decrease in altered intestinal permeability, particularly in children with IBS, compared to those with functional abdominal pain. However, the clinical relevance of this change is unknown, as tools to measure intestinal permeability lack appropriate standardization and validation in IBS populations.

 

Key Takeaways:

The evidence supporting the use of LGG for abdominal pain in IBS is limited to two clinical trials, which collectively involved 117 children with IBS. While the data suggests moderate potential benefits in reducing abdominal pain frequency, intensity, and pain resolution, these findings are preliminary. Further research with larger, well-designed studies would help to confirm these benefits. 

Dosing Instructions: 

 

Potentially Effective Dose(s)
  • 6 Billion CFU (taken as twice daily doses of 3 billion CFU)
Form
  • Capsules
Suggested Minimum 

Trial Duration

4 to 8 weeks, beneficial effects may endure after treatment cessation

 

 

References

  1. Kianifar H, Jafari SA, Kiani M, et al. Probiotic for irritable bowel syndrome in pediatric patients: a randomized controlled clinical trial. Electron Physician. 2015;7(5):1255–60. doi:10.14661/1255.
  2. Bausserman M, Michail S. The use of Lactobacillus GG in irritable bowel syndrome in children: a double-blind randomized control trial. J Pediatr. 2005;147(2):197–201. doi:10.1016/j.jpeds.2005.05.015.
  3. Pedersen N, Andersen NN, Vegh Z, et al. Ehealth: low FODMAP diet vs Lactobacillus rhamnosus GG in irritable bowel syndrome. World J Gastroenterol. 2014;20(43):16215–26. doi:10.3748/wjg.v20.i43.16215.
  4. Gawronska A, Dziechciarz P, Horvath A, et al. A randomized double-blind placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in children. Aliment Pharmacol Ther. 2007;25(2):177–84. doi:10.1111/j.1365-2036.2006.03175.x.
  5. Francavilla R, Miniello V, Magista AM, et al. A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain. Pediatrics. 2010;126(6)
    –52. doi:10.1542/peds.2010-0467.
Read More…

Five studies were initially identified that explored the effects of LGG (Lactobacillus rhamnosus GG) in IBS populations. (1,2,3,4,5) However, three of these studies were disqualified from consideration due to significant confounding factors that limited the reliability of their results. (1,2,3)  

  1. Unspecified Inulin Dose as a Major Confounder: Two studies included inulin in both the probiotic and placebo groups, but the exact dose of inulin was not specified. (1,2) This lack of detail makes it unclear what intervention was actually provided, severely complicating the interpretation of the results. Without knowing whether the inulin was provided in equal doses between the treatment and placebo groups, it is impossible to determine if the effects observed were due to LGG, inulin, or a combination of both. Additionally, given that inulin can have varying impacts on individuals with IBS—potentially exacerbating symptoms—this lack of clarity severely limits the interpretation of the results.
  2. Lack of Blinding and Control: Another study compared LGG with a control group and a low FODMAP diet group but lacked blinding, and the control group did not receive a placebo.(3) This flaw made the study unsuitable for inclusion in our analysis, as a placebo control is critical for assessing the true efficacy of a treatment.

Studies Included in our Evaluation

This leaves us with two studies that avoided major confounding factors and included IBS participants:

  • Study 1: The first study included 104 children described as having functional bowel disorders, of which only 37 had IBS. (4) Among the IBS participants, there was a near significant reduction in the frequency of abdominal pain in the LGG group compared to the placebo group (Cohen’s d = 0.62, p = 0.067), though there was no significant difference in pain severity. Treatment success, defined as “no pain,” was reported by 33% of the IBS LGG group versus 5% in the placebo group (p=0.029; Cohen’s h= 0.77). However, these results should be interpreted cautiously due to wide confidence intervals and the lack of baseline severity and frequency data specifically for the IBS participants.
  • Study 2: The second study was conducted in 141 children with IBS or functional abdominal pain, of which 80 participants had IBS. (5) The study noted improvements in both the frequency and intensity of abdominal pain among the IBS participants. At weeks 5-12, 79% of the IBS LGG group achieved treatment success for the number of pain episodes, compared to 45% in the placebo group (p=0.004; Cohen’s d= 0.69). At the 13-20 week follow-up, this increased to 82% for the LGG group and 50% for placebo (p=0.001; Cohen’s h= 0.79). While the intensity of pain episodes did not show significant improvement during weeks 5-12 (p=0.1), by weeks 13-20, 72% of the IBS LGG group reported treatment success for pain intensity, compared to 46% in the placebo group (p=0.029; Cohen’s d = 0.51). This study also observed that LGG led to a significant decrease in altered intestinal permeability, particularly in children with IBS, compared to those with functional abdominal pain. However, the clinical relevance of this change is unknown, as tools to measure intestinal permeability lack appropriate standardization and validation in IBS populations.

 

Key Takeaways:

The evidence supporting the use of LGG for abdominal pain in IBS is limited to two clinical trials, which collectively involved 117 children with IBS. While the data suggests moderate potential benefits in reducing abdominal pain frequency, intensity, and pain resolution, these findings are preliminary. Further research with larger, well-designed studies would help to confirm these benefits. 

Dosing Instructions: 

 

Potentially Effective Dose(s)
  • 6 Billion CFU (taken as twice daily doses of 3 billion CFU)
Form
  • Capsules
Suggested Minimum 

Trial Duration

4 to 8 weeks, beneficial effects may endure after treatment cessation

 

 

References

  1. Kianifar H, Jafari SA, Kiani M, et al. Probiotic for irritable bowel syndrome in pediatric patients: a randomized controlled clinical trial. Electron Physician. 2015;7(5):1255–60. doi:10.14661/1255.
  2. Bausserman M, Michail S. The use of Lactobacillus GG in irritable bowel syndrome in children: a double-blind randomized control trial. J Pediatr. 2005;147(2):197–201. doi:10.1016/j.jpeds.2005.05.015.
  3. Pedersen N, Andersen NN, Vegh Z, et al. Ehealth: low FODMAP diet vs Lactobacillus rhamnosus GG in irritable bowel syndrome. World J Gastroenterol. 2014;20(43):16215–26. doi:10.3748/wjg.v20.i43.16215.
  4. Gawronska A, Dziechciarz P, Horvath A, et al. A randomized double-blind placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in children. Aliment Pharmacol Ther. 2007;25(2):177–84. doi:10.1111/j.1365-2036.2006.03175.x.
  5. Francavilla R, Miniello V, Magista AM, et al. A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain. Pediatrics. 2010;126(6)
    –52. doi:10.1542/peds.2010-0467.
Read More…

Five studies were initially identified that explored the effects of LGG (Lactobacillus rhamnosus GG) in IBS populations. (1,2,3,4,5) However, three of these studies were disqualified from consideration due to significant confounding factors that limited the reliability of their results. (1,2,3)  

  1. Unspecified Inulin Dose as a Major Confounder: Two studies included inulin in both the probiotic and placebo groups, but the exact dose of inulin was not specified. (1,2) This lack of detail makes it unclear what intervention was actually provided, severely complicating the interpretation of the results. Without knowing whether the inulin was provided in equal doses between the treatment and placebo groups, it is impossible to determine if the effects observed were due to LGG, inulin, or a combination of both. Additionally, given that inulin can have varying impacts on individuals with IBS—potentially exacerbating symptoms—this lack of clarity severely limits the interpretation of the results.
  2. Lack of Blinding and Control: Another study compared LGG with a control group and a low FODMAP diet group but lacked blinding, and the control group did not receive a placebo.(3) This flaw made the study unsuitable for inclusion in our analysis, as a placebo control is critical for assessing the true efficacy of a treatment.

Studies Included in our Evaluation

This leaves us with two studies that avoided major confounding factors and included IBS participants:

  • Study 1: The first study included 104 children described as having functional bowel disorders, of which only 37 had IBS. (4) Among the IBS participants, there was a near significant reduction in the frequency of abdominal pain in the LGG group compared to the placebo group (Cohen’s d = 0.62, p = 0.067), though there was no significant difference in pain severity. Treatment success, defined as “no pain,” was reported by 33% of the IBS LGG group versus 5% in the placebo group (p=0.029; Cohen’s h= 0.77). However, these results should be interpreted cautiously due to wide confidence intervals and the lack of baseline severity and frequency data specifically for the IBS participants.
  • Study 2: The second study was conducted in 141 children with IBS or functional abdominal pain, of which 80 participants had IBS. (5) The study noted improvements in both the frequency and intensity of abdominal pain among the IBS participants. At weeks 5-12, 79% of the IBS LGG group achieved treatment success for the number of pain episodes, compared to 45% in the placebo group (p=0.004; Cohen’s d= 0.69). At the 13-20 week follow-up, this increased to 82% for the LGG group and 50% for placebo (p=0.001; Cohen’s h= 0.79). While the intensity of pain episodes did not show significant improvement during weeks 5-12 (p=0.1), by weeks 13-20, 72% of the IBS LGG group reported treatment success for pain intensity, compared to 46% in the placebo group (p=0.029; Cohen’s d = 0.51). This study also observed that LGG led to a significant decrease in altered intestinal permeability, particularly in children with IBS, compared to those with functional abdominal pain. However, the clinical relevance of this change is unknown, as tools to measure intestinal permeability lack appropriate standardization and validation in IBS populations.

 

Key Takeaways:

The evidence supporting the use of LGG for abdominal pain in IBS is limited to two clinical trials, which collectively involved 117 children with IBS. While the data suggests moderate potential benefits in reducing abdominal pain frequency, intensity, and pain resolution, these findings are preliminary. Further research with larger, well-designed studies would help to confirm these benefits. 

Dosing Instructions: 

 

Potentially Effective Dose(s)
  • 6 Billion CFU (taken as twice daily doses of 3 billion CFU)
Form
  • Capsules
Suggested Minimum 

Trial Duration

4 to 8 weeks, beneficial effects may endure after treatment cessation

 

 

References

  1. Kianifar H, Jafari SA, Kiani M, et al. Probiotic for irritable bowel syndrome in pediatric patients: a randomized controlled clinical trial. Electron Physician. 2015;7(5):1255–60. doi:10.14661/1255.
  2. Bausserman M, Michail S. The use of Lactobacillus GG in irritable bowel syndrome in children: a double-blind randomized control trial. J Pediatr. 2005;147(2):197–201. doi:10.1016/j.jpeds.2005.05.015.
  3. Pedersen N, Andersen NN, Vegh Z, et al. Ehealth: low FODMAP diet vs Lactobacillus rhamnosus GG in irritable bowel syndrome. World J Gastroenterol. 2014;20(43):16215–26. doi:10.3748/wjg.v20.i43.16215.
  4. Gawronska A, Dziechciarz P, Horvath A, et al. A randomized double-blind placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in children. Aliment Pharmacol Ther. 2007;25(2):177–84. doi:10.1111/j.1365-2036.2006.03175.x.
  5. Francavilla R, Miniello V, Magista AM, et al. A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain. Pediatrics. 2010;126(6)
    –52. doi:10.1542/peds.2010-0467.
02
Results
Overall evidence quality grade
91%

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
04
Clinical Studies
  • #
  • Study
  • Year
  • Author(s)
  • Journal
  • Reference
  • Daily Dose
  • Duration of Intervention
  • Form
  • Study Design
  • Age
  • Participants
    • Study #1
    • A randomized double-blind placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in children

    • 2007
    • Gawronska A, Dziechciarz P, Horvath A, et al.
    • Aliment Pharmacol Ther 2007;25(2):177–84

    • DOI: 10.1111/j.13652036.2006.03175
    • 6 billion CFU
    • 4 weeks
    • Capsule
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED
    • CHILDREN

    • ITT,PP (total) n=104,104
      IBS population ITT,PP (total) n=37,37 ITT,PP (probiotic total) n=52,52
      ITT, PP (IBS Probiotic total) n=18,18 ITT,PP (placebo total) n=52,52
      ITT, PP (IBS placebo total) n= 19,19
    • Study #2
    • A randomized controlled trial of Lactobacillus GG in children with functional abdominal pain

    • 2010
    • Francavilla R, Miniello V, Magista AM, et al.
    • Pediatrics 2010;126(6):e1445–52

    • DOI: 10.1542/peds.2010-0467
    • 6 billion CFU
    • 8 weeks
    • Capsule
      • RANDOMIZED
      • DOUBLE-BLIND
      • PLACEBO-CONTROLLED
      • PARALLEL GROUP
    • CHILDREN

    • ITT,PP (total) n=141,136
      ITT,PP (probiotic) n=71,69
      ITT,PP (placebo) n=70,67
      n=42 patients with IBS in the LGG group
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
      • No data

    • Bowel Habits
      • No data

    • Global IBS Symptoms
      • No data

    • Abdominal Pain / Discomfort
      • Among the IBS participants, there was a near significant reduction in the frequency of abdominal pain in the LGG group compared to the placebo group (Cohen’s d = 0.62, p = 0.067), though there was no significant difference in pain severity.

      • Treatment success, defined as “no pain,” was reported by 33% of the IBS LGG group versus 5% in the placebo group (p=0.029; Cohen’s h= 0.77).

      • However, these results should be interpreted cautiously due to wide confidence intervals and the lack of baseline severity and frequency data specifically for the IBS participants.

    • Bloating / Distention
      • No data

    • Gas / Flatulence
      • No data

    • Nausea / Vomiting
      • No data

    • Mental Health
      • No data

    • Quality of Life
      • No data

    • Miscellaneous Symptoms
      • No data

    • Notes
      • No data

  • Study #2

    • Diarrhea
      • No data

    • Constipation
      • No data

    • Bowel Habits
      • No data

    • Global IBS Symptoms
      • No data

    • Abdominal Pain / Discomfort
      • At weeks 5-12, 79% of the IBS LGG group achieved treatment success for the number of pain episodes, compared to 45% in the placebo group (p=0.004; Cohen’s d= 0.69). At the 13-20 week follow-up, this increased to 82% for the LGG group and 50% for placebo (p=0.001; Cohen’s h= 0.79). While the intensity of pain episodes did not show significant improvement during weeks 5-12 (p=0.1), by weeks 13-20, 72% of the IBS LGG group reported treatment success for pain intensity, compared to 46% in the placebo group (p=0.029; Cohen’s d = 0.51).

      • Treatment success was defined as a decrease of at least 50% in the number of episodes and intensity of pain.

    • Bloating / Distention
      • No data

    • Gas / Flatulence
      • No data

    • Nausea / Vomiting
      • No data

    • Mental Health
      • No data

    • Quality of Life
      • No data

    • Miscellaneous Symptoms
      • The intestinal permeability test (IPT) in children from the control group showed a mean Lactulose/Mannitol ratio (La/Ma) of 0.028 (± 0.008), with a 95% confidence interval ranging from 0.025 to 0.034. Based on these results, the normal cutoff value was set at a La/Ma of less than 0.034.

      • At week 12, treatment with the probiotic Lactobacillus rhamnosus GG (LGG) resulted in a statistically significant decrease in the number of children with altered intestinal permeability (40% in the LGG group compared to 21% in the placebo group, with a P value of <.03). Additionally, the mean La/Ma decreased significantly in the LGG group (0.030 [± 0.005]) compared to the placebo group (0.039 [± 0.011]), with a P value of <.02.

      • The probiotic’s effect was most notable in children with IBS rather than those with functional abdominal pain. However, it’s important to mention that the clinical significance of this change in the La/Ma ratio remains unclear.

    • Notes
      • No data