Bifidobacterial Supplement for Constipation

Overseen By Kevin O'Regan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Morinaga Milk Industry Co., LTD

Must not be taking: Laxatives, Antibiotics, Probiotics, others

Disqualifiers: Pregnancy, Alcohol abuse, Chronic disease, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement containing the B. longum strain (a type of probiotic) can relieve constipation in adults. The study will assess whether this supplement increases the number of spontaneous bowel movements, improves stool consistency, and enhances quality of life. Participants will take either the supplement or a placebo daily for eight weeks and will track their progress with an e-diary. This trial suits adults who have had fewer than three bowel movements per week over the past three months and who regularly experience hard stools. As an unphased trial, it offers participants the chance to contribute to understanding how probiotics might improve digestive health.

Will I have to stop taking my current medications?

The trial requires that participants do not take medications or supplements that affect bowel movements, such as regular laxatives, fiber, iron, and magnesium. If you are on long-term medication for a chronic disease, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that B. longum is likely safe for humans. Studies have found that people can safely take it by mouth for up to one year, either alone or with other probiotics. Most people do not experience serious side effects, though some might have mild digestive issues.

B. longum has been used to help with constipation, particularly in individuals with irritable bowel syndrome, a condition affecting the large intestine. It appears to aid by improving intestinal movement, making regular bowel movements easier.

Overall, B. longum is generally well-tolerated, with few reports of negative effects. Prospective trial participants should consult a healthcare professional about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for constipation rely on laxatives or fiber supplements to stimulate bowel movements. But B. longum, a probiotic supplement, works differently by introducing beneficial bacteria to your gut. This unique mechanism can help improve gut health and promote regularity by balancing the microbiome, a promising and natural approach. Researchers are excited about B. longum because it offers a potentially gentler and more holistic alternative to traditional treatments, aiming to address the root cause of constipation rather than just the symptoms.

What evidence suggests that this treatment might be an effective treatment for constipation?

Research has shown that Bifidobacterium longum (B. longum) can help with constipation. Studies have found that certain strains, such as B. longum W11, increase bowel movements and soften stools. People on a low-calorie diet experienced relief from constipation when taking B. longum. Another study found that B. longum BB536 improved chronic constipation in older adults. In this trial, participants will receive either B. longum or a placebo to evaluate its effectiveness. Overall, B. longum appears promising for easing constipation and improving gut health. ^{1 2 4 6 7}

Who Is on the Research Team?

Stacey Boetto

Principal Investigator

STTI

Are You a Good Fit for This Trial?

This trial is for healthy adults who are experiencing constipation. Participants will take a daily supplement containing the B. longum strain or a placebo for 8 weeks and keep an e-diary of their bowel movements. They must visit the clinic at the start and end of the study to submit stool samples.

Inclusion Criteria

Be able to give written informed consent

≥25% of bowel movements with stool firmness, less than Type-3 based on Bristol Stool Scale (BSS), within the past three months

Is willing to maintain the current diet and level of physical activity throughout the study period

Exclusion Criteria

Participants who are pregnant or wish to become pregnant during the study, or who are currently breastfeeding

I can have children but am not using any form of birth control.

I have not taken any probiotic or prebiotic supplements in the last 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants take a supplement containing the B. longum strain or a placebo every day

8 weeks

2 visits (in-person) for baseline and end of intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• B. longum

Trial Overview The trial is testing if taking a supplement with B. longum can increase spontaneous bowel movements, improve stool consistency, and enhance quality of life compared to a placebo in adults with constipation over an 8-week period.

How Is the Trial Designed?

Group I: B. longum Experimental Treatment 1 Intervention

Participants will be instructed to consume the capsule containing the live B. longum strain.

Group II: Placebo Placebo Group 1 Intervention

Participants will be instructed to consume the placebo capsule without any live bacteria.

B. longum is already approved in Japan, China for the following indications:

Approved in Japan as Bifidobacterium longum for:

• Chronic constipation

Approved in China as Bifidobacterium longum for:

• Functional constipation

Who Is Running the Clinical Trial?

Morinaga Milk Industry Co., LTD

Lead Sponsor

Trials

6

Recruited

970+

Published Research Related to This Trial

In a study involving 13 female patients with chronic constipation, daily consumption of the probiotic Bifidobacterium infantis strain 35624 for eight weeks did not significantly alter the overall composition of their fecal microbiota, indicating stability in gut bacteria despite probiotic intake.

The study found that while the diversity of gut bacteria remained unchanged, the presence of the butyrate-producing bacteria Oscillospira was notably correlated with the probiotic's effects, suggesting a potential mechanism for how probiotics may influence gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal bacterial microbiota in constipated patients before and after eight weeks of daily Bifidobacterium infantis 35624 administration. Amieva-Balmori, M., García-Mazcorro, JF., Martínez-Conejo, A., et al.[2022]

Three strains of Bifidobacterium longum were tested in colon-released capsules, showing that they effectively improved fecal water content and intestinal motility in constipated rats by regulating gastrointestinal peptides and intestinal flora.

The optimal doses for relieving constipation were found to be 104 CFU/day for strain FGSZY6M4, 106 CFU/day for strain FJSWXJ10M2, and 108 CFU/day for strain FSDJN6M3, indicating that colon-released capsules can enhance the efficacy of probiotics while reducing the required dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Dose-Effect Relationship of Bifidobacterium longum in Relieving Loperamide Hydrochloride-Induced Constipation in Rats through Colon-Released Capsules. Zhou, X., Mao, B., Tang, X., et al.[2023]

In a study involving 79 elderly participants with chronic constipation, the probiotic Bifidobacterium longum BB536 showed significant improvements in bowel movements compared to a placebo, particularly in stool frequency and evacuation failure.

While the primary endpoint of overall constipation severity did not reach statistical significance, the probiotic was deemed safe with few adverse events, indicating it may be a beneficial option for managing chronic constipation in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of Bifidobacterium longum BB536 in Elderly Individuals With Chronic Constipation: A Randomized Controlled Trial. Takeda, T., Asaoka, D., Nojiri, S., et al.[2023]

In a study involving 636 patients with constipation-variant IBS, a symbiotic treatment combining the probiotic Bifidobacterium longum W11 and the prebiotic Fos Actilight significantly increased stool frequency from an average of 2.9 to 4.1 times per week.

The treatment also led to a notable reduction in abdominal pain and bloating, with severe symptoms decreasing from 62.9% to 9.6% for bloating and from 38.8% to 4.1% for abdominal pain, indicating both efficacy and safety in managing IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a symbiotic preparation on the clinical manifestations of irritable bowel syndrome, constipation-variant. Results of an open, uncontrolled multicenter study. Colecchia, A., Vestito, A., La Rocca, A., et al.[2015]

In a study of 100 cancer patients with functional constipation during chemotherapy, those taking Bifidobacterium tetragenous tablets showed a 96% response rate in controlling constipation, compared to only 32% in the control group receiving chemotherapy alone.

The treatment was found to be safe, with only 2% of patients reporting diarrhea, indicating that Bifidobacterium tetragenous is an effective and well-tolerated option for managing constipation in cancer patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Bifidobacterium tetragenous viable bacteria tablets for cancer patients with functional constipation. Liu, J., Huang, XE.[2019]

In a randomized, double-blind study involving 120 healthy individuals, taking 25 billion colony-forming units of heat-killed Bifidobacterium longum CLA8013 for 2 weeks significantly increased defecation frequency compared to a placebo.

The treatment also improved stool volume, consistency, and reduced straining and pain during defecation, with no reported adverse events, indicating both efficacy and safety for constipation relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bifidobacterium longum CLA8013 on bowel movement improvement: a placebo-controlled, randomized, double-blind study. Okada, K., Takami, D., Makizaki, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11356487/

The Anti-Constipation Effect of Bifidobacterium Longum ... B. longum W11, previously reported to be clinically effective against constipation [10,11,12,13] possesses the abfA and abfB genes and increases ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405457721000528

Bifidobacterium longum W11: Uniqueness and individual ... In particular, its role in alleviating constipation was also confirmed in subjects for whom a low-calorie weight-loss diet led to the slowing down of gut ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9973440/

Usefulness of Bifidobacterium longum BB536 in Elderly ... These results suggest that B. longum BB536 supplementation is safe and partially effective for improving chronic constipation in elderly individuals.

4. frontiersin.org frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2021.770248/full

Recent Development of Probiotic Bifidobacteria for ... B. longum W11 was also found to relieve the constipation symptoms of patients with irritable bowel syndrome, synergize with rifaximin as an adjuvant antibiotic ...

5. researchgate.net researchgate.net/publication/382974267_The_Anti-Constipation_Effect_of_Bifidobacterium_Longum_W11_Is_Likely_Due_to_a_Key_Genetic_Factor_Governing_Arabinan_Utilization

The Anti-Constipation Effect of Bifidobacterium Longum ... Probiotics, such as Bifidobacteria, can improve this bowel disorder; however, efficacy is strain-dependent. We determine that a genetic factor, ...

6. webmd.com webmd.com/vitamins-supplements/ingredientmono-1667-BIFIDOBACTERIUM+LONGUM.aspx?activeIngredientId=1667&activeIngredientName=BIFIDOBACTERIUM+LONGUM

Bifidobacterium Longum - Uses, Side Effects, and More When taken by mouth: B. longum is likely safe. It's been used safely alone and together with other probiotics for up to one year. Some people might experience ...

7. mdpi.com mdpi.com/2076-2607/12/8/1626/review_report

The Anti-Constipation Effect of Bifidobacterium Longum ... The Anti-Constipation Effect of Bifidobacterium Longum W11 Is Likely Due to a Key Genetic Factor Governing Arabinan Utilization. Microorganisms 2024, 12(8), ...