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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to investigate whether a supplement containing the B. longum strain works to alleviate constipation in adults. The main questions it aims to answer are: Does a supplement containing the B. longum strain increase the number of spontaneous bowel movements per week, improve stool consistency, and enhance the quality of life? Participants will: Take a supplement containing the B. longum strain or a placebo every day for 8 weeks. Maintain an e-diary as per the instructions. Visit the clinic for screening assessments, baseline, and end of the intervention for stool sample submission.

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.

What data supports the effectiveness of the treatment Bifidobacterium longum for constipation?

Research shows that Bifidobacterium longum can help improve bowel movements in people with constipation. In one study, taking B. longum increased how often people went to the bathroom and improved stool consistency, making it easier to pass. Another study found that B. longum helped relieve constipation in rats by improving gut health. ^{1 2 3 4 5}

Is Bifidobacterium longum safe for human use?

Studies on Bifidobacterium longum, including strains like CLA8013 and BB536, have shown no relevant safety issues in humans, even when used for conditions like constipation and irritable bowel syndrome. ^{1 3 4 5 6}

How does the treatment B. longum differ from other treatments for constipation?

B. longum is unique because it is a probiotic (beneficial bacteria) that can help improve bowel movements by balancing gut bacteria, which is different from traditional laxatives that simply stimulate bowel movements. It has been shown to increase defecation frequency and improve stool consistency without causing adverse effects, making it a gentle option for managing constipation. ^{1 2 4 5 6}

Research Team

Stacey Boetto

Principal Investigator

STTI

Eligibility Criteria

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

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

Be able to give written informed consent

I am between 18 and 65 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. Mexico pubmed.ncbi.nlm.nih.gov

Fecal bacterial microbiota in constipated patients before and after eight weeks of daily Bifidobacterium infantis 35624 administration. [2022]

2. Thailand pubmed.ncbi.nlm.nih.gov

Efficacy of Bifidobacterium tetragenous viable bacteria tablets for cancer patients with functional constipation. [2019]

3. Switzerland 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. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

Effects of Bifidobacterium longum CLA8013 on bowel movement improvement: a placebo-controlled, randomized, double-blind study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Usefulness of Bifidobacterium longum BB536 in Elderly Individuals With Chronic Constipation: A Randomized Controlled Trial. [2023]

6. Italy 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. [2015]