Jean-Marc Sabaté and Franck Iglicki Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome World J Gastroenterol. 2022 Feb 21; 28(7): 732–744. Published online 2022 Feb 21. doi: 10.3748/wjg.v28.i7.732 PMCID: PMC8891724 PMID: 35317278 About Bifantis for Professionals Promote & Support a Healthy Digestive System* Liam O’Mahony Jane McCarthy Peter Kelly J. Kevin Collins Fergus Shanahan Eamonn M.M. Quigley Lactobacillus and bifidobacterium in irritable bowel syndrome: Symptom responses and relationship to cytokine profiles CLINICAL-ALIMENTARY TRACT| VOLUME 128, ISSUE 3, P541-551, MARCH 2005 Peter J. Whorwell, M.D., F.R.C.P., Linda Altringer, B.S., Jorge Morel, Ph.D., Yvonne Bond, Duane Charbonneau, Ph.D., Liam O’Mahony, Ph.D., Barry Kiely, Ph.D., Fergus Shanahan, M.D., F.R.C.P., F.R.C.P.I., F.A.C.P., and Eamonn M. M. Quigley, M.D., F.R.C.P., F.A.C.P., F.A.C.G., F.R.C.P.I. Efficacy of an Encapsulated Probiotic Bifidobacterium infantis 35624 in Women with Irritable Bowel Syndrome Duane Charbonneau, Roger D. Gibb & Eamonn M.M. Quigley Fecal excretion of Bifidobacterium infantis 35624 and changes in fecal microbiota after eight weeks of oral supplementation with encapsulated probiotic 02 Apr 2013. Fuqiang Yuan,Huijuan Ni,Carl V. Asche,Minchul Kim,Saqib Walayat &Jinma Ren Efficacy of Bifidobacterium infantis 35624 in patients with irritable bowel syndrome: a meta-analysis Pages 1191-1197 | Received 06 Dec 2016, Accepted 03 Feb 2017 Jean-Marc Sabaté and Franck Iglicki Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome World J Gastroenterol. 2022 Feb 21; 28(7): 732–744. Published online 2022 Feb 21. doi: 10.3748/wjg.v28.i7.732 PMCID: PMC8891724 PMID: 35317278 The first series of photographs (upper panels) shows the dissolution experiment and time to capsule rupture. Note that for the high-dose capsule, not only is the time significantly longer but also the capsule breaks apart in a different manner. The second series of photographs (lower panels) shows the formulation response to exposure to moisture. Capsules were exposed to ambient temperatures and humidity overnight and then opened. The high dose capsule solidified while, under the same conditions, the lower dosage capsules continued to disperse in a normal fashion when opened.

Last Updated: 13 February 2023

Bifidobacterium Longum 35624 Probiotic For IBS – Here’s What We Found

This research has 9 references

Researched & Written By:

In this analysis, we focus on 3 trials that focused solely on B. longum 35624. But it’s worth noting that there has also been a strain-specific meta-analysis of B. longum 35624 which accounted for studies on this strain in isolation or B. longum 35624 containing strain-blends. Recently, a 2022 open-label trial was published as well. The results of these studies will be discussed, but the study details below pertain to the currently available randomized, placebo-controlled trials for this isolated probiotic strain.

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Probiotic Description B. Longum 35624

Names & Identifiers

Bifidobacterium longum 35624
B. longum 35624
- Formerly named Bifidobacterium infantis 35624; (B. infantis 35624) 1
Align probiotics; “Bifantis” 2

Strain(s)

Bifidobacterium longum

Manufacturer and/or Source

Common brand name: Align probiotics 3
- Available without added herbs, vitamins, or prebiotics in their 24/7 digestive support product or 5x Extra strength 24/7 digestive support product
Align probiotics is owned by the parent company, Procter & Gamble

3 IBS Studies Compared

In our research, we came across 3 randomized, placebo-controlled trials in IBS for this probiotic.

Study details

	Study 1	Study 2	Study 3
Trial Design	Randomized, double blind, placebo controlled trial with 2 arms	Randomized, double-blind, placebo-controlled, multicenter, dose-ranging study	Single-center, randomized, double-blind, placebo-controlled tria
	2005	2006	2013
Reference	O'Mahony L, McCarthy J, Kelly P, et al. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles.Gastroenterol 2005;128(3):541–51. 4	Whorwell PJ, Altringer L, Morel J, et al. Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. Am J Gastroenterol 2006;101(7):1581–90. doi: 10.1111/j.1572-0241.2006.00734.x. 5	Duane Charbonneau, Roger D. Gibb & Eamonn M.M. Quigley (2013) Fecal excretion of Bifidobacterium infantis 35624 and changes in fecal microbiota after eight weeks of oral supplementation with encapsulated probiotic, Gut Microbes, 4:3, 201-211, DOI: 10.4161/ gmic.24196 6

Populations studied

*ITT = “Intent to Treat Population” ; *PP = “Per Protocol Population”

Study duration and stages

	Study 1	Study 2	Study 3
Run-In Period	4 weeks	2 weeks	2 weeks
Intervention Period	8 weeks	4 weeks	8 weeks
Follow-up Period	4 weeks	2 weeks	2 weeks

Dosing information

	Study 1	Study 2	Study 3
IBS Subtypes	“Alternators” 45% IBS-D 28% IBS-C 26%	IBS-D (55.5%) IBS-C (20.7%) IBS-A (23.8%)	Included participants with IBS-D, IBS-C, and IBS-M; number or percentage of individuals from each subtype was not specified
Gender	Female (64%) Male (36%)	Female (100%)	Female (81%) Male (19%)
Age Range	18-75 years with IBS (Rome II)	18-65 (Rome II)	20-65 years (Rome II)
Country / Location	Ireland	Ireland	Ireland
Number of Participants	Total ITT Population n= 80 ( n=75 were described as “evaluable”) Total PP Population: n=67 longum 35624 ITT and PP Population Not reported L salivarius UCC4331 ITT and PP Population Not reported Placebo ITT and PP Population Not reported	Total ITT Population n=362 ITT Allocation: n= 90 (10 billion CFU/mL dose) n= 90 (100 million CFU/mL dose) n= 90 (1 million CFU/mL dose) n= 92 (placebo) Total PP population: 293	IBS: ITT,PP (total) n=76,61 ITT,PP (probiotic) n=39,33 ITT,PP (placebo) n=37,28 Healthy: ITT,PP (total/probiotic) n=41,36

	Study 1	Study 2	Study 3
Dose	10 billion CFU/day; 1 dose per day	3 trialed doses: 10 billion CFU/mL 100 million CFU/mL 1 million CFU/mL	1 billion CFU per capsule (range of 100 million to 10 billion CFU/capsule)
Form	Malted milk drink	Capsules; 1 capsule per day for each dose	Capsules

Study methods

	Study 1	Study 2	Study 3
Study Endpoints	IL-10/IL-12 ratio Quality of life Abdominal pain or discomfort, Bloating or distention Bowel movement difficulty could reflect either difficulty with evacuation (ie, straining or a sense of incomplete evacuation) or urgency.	Primary Endpoint: Abdominal pain/ discomfort at week 4 Secondary Endpoints Bloating/Distention Sense of incomplete evacuation Passage of gas Straining Bowel habit satisfaction Quality of life Mental health as assessed by Hospital Anxiety and Depression scale (HADS)	Primary endpoint: Levels of fecal excretion of the probiotic microbe assessed by quantitative PCR (qPCR). Secondary endpoints: Relative abundance of the assessed fecal microbiota IBS symptoms
Tools to Measure Symptom Change	Each symptom was evaluated using both an ordinal scale (Likert scale; maximum score, 7) and a 10-cm visual analogue scale (VAS; maximum score, 10). A composite score, comprised of the sums of the 3 cardinal symptoms (pain/discomfort, bloating/distention, and bowel movement difficulty scores) was also calculated for each patient (maximum score: Likert scale, 21; VAS, 30). Bowel movement frequency was recorded as number per day, and consistency was evaluated using the Bristol Stool Scale. Quality of life was assessed by administration of an IBS-specific questionnaire developed and validated by Drossman et al. Blood samples for blood count, serum chemistry, and quantitative immunoglobulin levels were obtained at initial evaluation and at the end of the study and analyzed using standard laboratory methods. Peripheral blood samples from patients with IBS was obtained both before and after treatment for cytokine levels and compared with that obtained from a group of age- and sex-matched healthy volunteers (n = 20) Stool samples for fecal flora analysis were obtained at randomization and at the end of the treatment phase.	Interactive voice recording system (phone call monitoring system which recorded the following symptoms: abdominal pain/discomfort, bloating/distention, sense of incomplete evacuation, straining, urgency of bowel movements, passage of gas and mucus, and bowel habit satisfaction.) Each symptom was recorded on a 6-point 0-5 scale Stool frequency and consistency was recorded using the Bristol Stool Form scale Subjective Global Assessment (SGA) recorded at the end of each week IBS quality of life questionnaire (IBS-QOL) Hospital Anxiety and Depression Scale (HADS)	Quantitative PCR analysis of 10 taxa Symptoms were graded on a six-point scale, where 0 = none, 1 = very mild, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. The following symptoms were assessed daily: abdominal pain/discomfort; bloating/distension; urgency; straining; incomplete bowel evacuation; flatulence; and an overall rating of symptom severity. Subjects recorded the number of bowel movements per day and stool consistency (Bristol Stool Form Scale) and rated their level of satisfaction with bowel habits (where 0 = very satisfied, 1 = satisfied, 2 = somewhat satisfied, 3 = somewhat dissatisfied, 4 = dissatisfied and 5 = very dissatisfied). A composite score of IBS symptoms was derived from the sum of scores for abdominal pain/discomfort, bloating/distension and bowel habit satisfaction during baseline, week 4 and week 8 of dosing.
Responder Definition	None	None	None
Intent to Treat or Per Protocol Statistical Analysis?	Seemingly a modified ITT analysis (evaluated 75/80 subjects with a PP population of 67)	Intent to treat analysis	Per protocol
Subtype Specific Analysis?	No	Yes	No
Study Funding and Conflicts of interest	Supported in part by Science Foundation Ireland in the form of a centre grant (Alimentary Pharmabiotic Centre), the Health Research Board of Ireland, the Higher Education Authority of Ireland, and the European Union (PROGID QLK-2000-00563). The authors are affiliated with a multidepartmental university campus company (Alimentary Health Ltd) that investigates host-flora interactions and the therapeutic manipulation of these interactions in various human and animal disorders. The content of this report was neither influenced nor constrained by this fact.	Financial support: The authors are supported, in part, by grants from the Higher Education Authority, Science Foundation Ireland, the Health Research Board, the European Union and Procter and Gamble. Potential conflicts: Peter J. Whorwell Linda Altringer, Jorge Morel, Yvonne Bond, and Duane Charbonnean are employees of Procter and Gamble. Liam O’Mahony is an employee of Alimentary Health and the Alimentary Pharmabiotic Centre. Barry Kiely is an employee of Alimentary Health. Fergus Shanahan and Eamonn M.M. Quigley are affiliated with a multidepartmental university campus company (Alimentary Health), which investigates host-flora interactions and the therapeutic manipulation of these interactions in various human and animal disorders. The content of this article was neither influenced nor constrained by this fact.	The study was funded by The Procter and Gamble Company, which sells B. infantis 35624 under the trade name, Align®. D.C., PhD and R.D.G., PhD are employees of The Procter and Gamble Company. E.M.M.Q., MD has served as a speaker, a consultant and an advisory board member to Procter and Gamble and has received funding from The Procter and Gamble Company. Writing support provided by Deborah Hutchins, PhD ELS was funded by The Procter and Gamble Company.

Study 1

Results

B. infantis 35624 normalized IL-10/IL-12 cytokine ratios, which, prior to treatment, were described as abnormal and indicative of a more inflammatory ratio

Stool samples confirmed that probiotics ingested by participants survived GI transit
B. infantis 35624 improved composite IBS symptom scores calculated from the sum of scores for abdominal pain/discomfort, bloating/distention, and bowel movement difficulty.
For individual symptoms compared to placebo, B. infantis 35624:
- Significantly reduced abdominal pain/discomfort scores during most weeks of the treatment phase
- Significantly reduced bloating and distention at weeks 2,5, and 6
- Significantly reduced bowel movement difficulty score at weeks 2,3 and 5-7
- Stool frequency and consistency was reportedly not improved in the B. infantis 35624 group
For quality of life, there were no stark improvements from B. infantis 35624. The only quality of life parameter that showed a statistically significant improvement in the B. infantis 35624 group was for health worry.

Evidence quality critique (weaknesses)

No reporting on number of participants in each probiotic arm of the study and in the placebo group
No subtype specific analysis
Abdominal pain and “discomfort” were analyzed together. (Measuring “discomfort” is an area of contention for patient reported outcome measures in IBS given that broad and varying interpretation of this term has previously been noted.)
Authors did not define responder thresholds, making the clinical significance of improvements difficult to interpret
It was challenging to discern percent change in symptom scores from baseline given how data was presented (box and whiskers charts were plotted on line graphs; numerical values for mean symptom scores and standard deviations were graphically represented, but otherwise not provided)
Four adverse events were reported in the study, but the study authors did not mention the arm(s) of the study in which these events occurred.
There was an uneven distribution of patients between arms based on symptom severity but also lifestyle. While symptom severity was adjusted for statistically, habitual smoking was more prevalent amongst the L. salivarius UCC4331 and placebo group compared to the B. longum 35624 group.
There was insufficient data available for certain individual symptom parameters such as stool frequency and consistency

AGA evidence certainty rating

*AGA = American Gastroenterological Association

Study 2

Results

Significant improvements (detailed below) were only observed in the moderate 100 million CFU/mL dose.
Given that a prior study found benefits at the higher 10 billion CFU/mL dose when given in a milk beverage rather than a capsule, it was believed that an encapsulation issue may have played a role in the lack of efficacy for the higher dose.
Upon further investigation, it was found that the higher dose capsule took significantly longer to break apart than the lower dose capsule when exposed to moisture. The higher dose also appeared to coagulate, suggesting that the encapsulation method of this dose proved to be an inadequate delivery mechanism, likely resulting in null treatment effects.

Symptom Parameter	Results for 100 million CFU/mL dose
Abdominal Pain/discomfort	38.4% improvement from baseline (statistically significant compared to placebo p<0.03)
Bloating/distention	29.5% improvement from baseline (statistically significant compared to placebo p<0.05
Urgency	26.7% improvement from baseline (statistically significant compared to placebo p<0.09)
Incomplete Evacuation	27.4% improvement from baseline (statistically significant compared to placebo p<0.04)
Straining	22.4% improvement from baseline (statistically significant compared to placebo p<0.02)
Passage of gas	23% improvement from baseline (statistically significant compared to placebo p<0.04)
Bowel habit satisfaction	22.3% improvement from baseline (statistically significant compared to placebo p<0.02)
Overall assessment of IBS symptoms	30.2% improvement from baseline (statistically significant compared to placebo p<0.01)
Composite score	29.5% improvement from baseline (statistically significant compared to placebo p<0.02 compared to placebo
Global assessment of pain relief	statistically significant compared to placebo p<0.36
Global assessment of IBS relief	33% greater than placebo (statistically significant compared to placebo p<0.02)
Stool frequency	While there were no statistical differences in the change in BM frequency from baseline between placebo and Bifidobacterium at the midpoint of the distribution frequency, significant differences (p<0.05) were noted at both ends (i.e., below the 15th percentile and above the 81st percentile) of the frequency distribution, with the Bifidobacterium-treated group experiencing a normalization of bowel habit in each instance For the 1x 108 dose (Post hoc analysis) Increased stool frequency for people with low percentile stool frequency (10th and 15th percentiles) (0.71-0.80 stools/day average at baseline increased to 1.28-.31 BMs/day at week 4) Decreased frequency in 81st-90th percentile (people with 2.57-3.14 BMs/day at baseline) decreased BM frequency to 1.78-.93 BMs/day) All stool frequency results P <0.05 – significant compared to placebo
IBS-D	Improved bowel habit satisfaction (p 0.014 compared to placebo); Improved overall assessment of IBS symptoms (p=0.028) improved composite score (p=0.027); mysteriously improved incomplete evacuation (p 0.008) and improved straining (p0.007) For the 1x 108 dose (Post hoc analysis) Increased stool frequency for people with low percentile stool frequency (10th and 15th percentiles) (0.71-0.80 stools/day average at baseline increased to 1.28-.31 BMs/day at week 4) Decreased frequency in 81st-90th percentile (people with 2.57-3.14 BMs/day at baseline) decreased BM frequency to 1.78-.93 BMs/day) All stool frequency results P <0.05 – significant compared to placebo
IBS-C	Improved abdominal pain/discomfort (p=0.036) improved bowel habit satisfaction (p=0.047) For the 1x 108 dose (Post hoc analysis) Increased stool frequency for people with low percentile stool frequency (10th and 15th percentiles) (0.71-0.80 stools/day average at baseline increased to 1.28-.31 BMs/day at week 4) Decreased frequency in 81st-90th percentile (people with 2.57-3.14 BMs/day at baseline) decreased BM frequency to 1.78-.93 BMs/day) All stool frequency results P <0.05 – significant compared to placebo
IBS-A	No significant improvements noted for this subtype
HADS score	No improvement
QOL	No improvement

Evidence quality critique (weaknesses)

Abdominal pain and “discomfort” were analyzed together.
Authors did not define responder thresholds, making the clinical significance of improvements challenging to determine
Short intervention duration of 4 weeks

AGA evidence certainty rating

*AGA = American Gastroenterological Association

Study 3

Results

Daily administration of the encapsulated probiotic supplement (1 billion CFU per capsule) for eight weeks in subjects with IBS resulted in a significant increase (approximately 1.5 log ng DNA/g stool) relative to placebo in the levels of fecal excretion of this microbe as measured by quantitative PCR (p < 0.0001); similar changes vs. baseline were observed for healthy subjects.

Due to a decline in concentration of this microbe in fecal samples during the follow-up period, the authors concluded that consistent administration of this probiotic is necessary to maintain steady-state levels of transit through the GI-tract.
There was no significant difference between groups of IBS subjects in abdominal pain, bloating, urgency, incomplete evacuation, straining, gas, or for overall symptom severity after 4 and 8 weeks of treatment.

Evidence quality critique (weaknesses)

No responder threshold established for secondary clinical outcomes
Limited microbiota analysis only examined changes in 10 taxa
Per protocol analysis
No subtype specific analysis

AGA evidence certainty rating

*AGA = American Gastroenterological Association

Other Supporting Evidence

2017 meta-analysis

A 2017 meta-analysis which reviewed the 3 RCTs described above, as well as two other studies which administered B. infantis 35624 in combination with other strains concluded the following:

“In this study, our meta-analysis data has shown that treatment with composite probiotics consisting of B. infantis on IBS patients could significantly alleviate the symptoms of IBS without significant adverse effects, but not for single probiotic B. infantis. Because of the limitations of this meta-analysis, more large-sized randomized clinical trials are still needed to prove the efficacy of B. infantis on IBS. Future studies are also expected to examine the long-term therapeutic effect of B. infantis and other probiotics on IBS patients, and further explore the mechanism underlying the beneficial effect of them.” 7

2022 open-label trial

An open-label trial in 2022 conducted in 233 IBS patients of varying subtypes concluded the following:

“This study conducted in IBS patients diagnosed according to the Rome IV criteria and who had different transit pattern subtypes and different levels of symptom severity showed that 30 d of treatment with B. longum 35624, whose superiority to placebo has already been established, reduced IBS disease severity and improved patient quality of life in all subgroups of patients, and notably in those with the most severe form of IBS.” 8

Key Takeaways

B. longum 35624 (formerly B. infantis 35624) delivered in doses ranging from 100 million to 10 billion CFU/day, with administration lasting from 4 to 8 weeks, has shown benefits for global IBS symptom reduction compared to placebo in 2 out of 3 randomized, placebo-controlled trials.
When statistically significant benefits were observed compared to placebo, they were for the following symptom parameters:

Abdominal pain/discomfort
Bloating/distention
Incomplete evacuation
Incomplete evacuation
Straining
Passage of gas
Bowel habit satisfaction
Overall assessment of
IBS symptoms
Composite IBS symptom scores
Global assessment of pain relief
Global assessment of IBS relief

All randomized, placebo-controlled trials for this strain lacked responder thresholds, making the clinical significance of symptom changes compared to placebo challenging to interpret
In one trial, B. longum 35624 was found to improve markers of inflammation in IBS subjects (IL-10/IL-12 ratio)
All randomized placebo-controlled trials to date for this strain have been in predominantly female IBS populations, leaving us with less information about this strain in male IBS populations.
A 2017 meta-analysis evaluating these 3 trials and other strain blends containing B. longum 35624 concluded that this probiotic in its single-strain form did not significantly alleviate symptoms of IBS, though strain combinations containing B. longum 35624 did.
A relatively large 2022 open-label trial which lacked a placebo group found favorable effects for B. longum 35624 in reducing global IBS symptoms at a dose of 1 billion CFU/day for 30 days, particularly in those with the most severe forms of IBS.

The Bottom Line

Some evidence suggests that B. longum 35624 may improve global IBS symptoms across subtypes when administered at doses ranging from 100 million to 10 billion CFU/day over a duration of 4 to 8 weeks.
Given conflicting and limited evidence, more randomized, placebo-controlled trials with established responder thresholds are needed to discern the usefulness of B. longum 35624 for the management of IBS symptoms.
If a trial of B. longum 35624 is desired for the management of IBS symptoms, we suggest a limited therapeutic trial in the dose range specified above for a minimum of 4 weeks, taken consistently on a daily basis.

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About the Authors

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Bailey Hanna MS, RDN

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Bifidobacterium Longum 35624 Probiotic For IBS – Here’s What We Found

Which Foods Really Trigger Your IBS?

Table of Contents

Probiotic Description B. Longum 35624

3 IBS Studies Compared

Study details

Populations studied

Study duration and stages

Dosing information

Study methods

Study 1

Results

Evidence quality critique (weaknesses)

AGA evidence certainty rating

Study 2

Results

Evidence quality critique (weaknesses)

AGA evidence certainty rating

Study 3

Results

Evidence quality critique (weaknesses)

AGA evidence certainty rating

Other Supporting Evidence

2017 meta-analysis

2022 open-label trial

Key Takeaways

The Bottom Line

Which Foods Really Trigger Your IBS?

About the Authors

Table of Contents

About the Author

Biography

List of Written Research Articles

About the Author

Biography

List of Written Research Articles

About the Author

Biography

List of Written Research Articles

Evidence Based

Research Methodology

Strength of Evidence

Transparency

Avoidance of Bias

Research

About

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