Bifidobacterial Supplement for Constipation

Recruiting in Palo Alto (17 mi)

Overseen by Stacey Boetto

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Atlantia Clinical Trials Chicago, IL

Who Is Running the Clinical Trial?

Morinaga Milk Industry Co., LTD Lead Sponsor

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] In recent years, probiotics have been used in functional gastrointestinal disorders, including chronic constipation (CC). The effect of Bifidobacterium infantis strain 35624 on the gut microbiota of CC patients has not been previously studied. Our aim was to analyze the fecal microbiota of constipated patients, before and after consuming a single-strain probiotic (B. infantis strain 35624).

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

Efficacy of Bifidobacterium tetragenous viable bacteria tablets for cancer patients with functional constipation. [2019] To investigate the efficacy and side effects of Bifidobacterium tetragenous viable bacteria tablets in treating cancer patients with functional constipation during chemotherapy.

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] Constipation is a common disease affecting humans. Bifidobacterium longum is reportedly effective in relieving constipation. Current studies generally focus on the dose-response relationship of oral doses; however, the dose-effect relationship of B. longum in the colon, which is the primary site where B. longum exerts constipation-relieving effects, to treat constipation has not been studied. Herein, three strains of B. longum (FGSZY6M4, FJSWXJ10M2, and FSDJN6M3) were packaged in colon-released capsules to explore the dose-effect relationship in the colon. For each strain, three groups of capsules (104, 106, and 108 CFU/capsule, respectively) and one group of free probiotics (108 CFU/mL) were used to explore the colonic dose effect of B. longum. The results showed that the three strains of B. longum improved fecal water content and promoted intestinal motility by regulating gastrointestinal peptide (MTL, GAS, and VIP), aquaporin-3, and 5-hydroxytryptamine levels while promoting gastrointestinal motility and relieving constipation by regulating the intestinal flora composition of constipated rats and changing their metabolite content (short-chain fatty acids). Among the three free bacterial solution groups (108 CFU/mL), FGSZY6M4 was the most effective in relieving constipation caused by loperamide hydrochloride in rats. The optimal effective dose of each strain was 6M4 (104 CFU/day), 10M2 (106 CFU/day), and S3 (108 CFU/day) of the colon-released capsules. Therefore, for some effective strains, the dose of oral probiotics can be reduced by colon-released capsules, and constipation can be relieved without administering a great number of bacterial solutions. Therefore, investigating the most effective dose of B. longum at the colon site can help to improve the efficiency of relieving constipation.

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

Effects of Bifidobacterium longum CLA8013 on bowel movement improvement: a placebo-controlled, randomized, double-blind study. [2023] A placebo-controlled, randomized, double-blind study was conducted to evaluate the effect of taking 25 billion colony-forming units of heat-killed Bifidobacterium longum CLA8013 over 2 weeks on bowel movements in constipation-prone healthy individuals. The primary endpoint was the change in defecation frequency between the baseline and 2 weeks after the intake of B. longum CLA8013. The secondary endpoints were the number of days of defecation, stool volume, stool consistency, straining during defecation, pain during defecation, feeling of incomplete evacuation after defecation, abdominal bloating, fecal water content, and the Japanese version of the Patient Assessment of Constipation Quality of Life. A total of 120 individuals were assigned to two groups, 104 (control group, n=51; treatment group, n=53) of whom were included in the analysis. After 2 weeks of consuming the heat-killed B. longum CLA8013, defecation frequency increased significantly in the treatment group compared with that in the control group. Furthermore, compared with the control group, the treatment group showed a significant increase in stool volume and significant improvement in stool consistency, straining during defecation, and pain during defecation. No adverse events attributable to the heat-killed B. longum CLA8013 were observed during the study period. This study revealed that heat-killed B. longum CLA8013 improved the bowel movements of constipation-prone healthy individuals and confirmed that there were no relevant safety issues.

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

Usefulness of Bifidobacterium longum BB536 in Elderly Individuals With Chronic Constipation: A Randomized Controlled Trial. [2023] Few reports exist regarding the therapeutic effects of probiotics on chronic constipation in elderly individuals. This study evaluated the effects of Bifidobacterium longum BB536 in elderly individuals with chronic constipation.

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] Irritable bowel syndrome (IBS) is frequently associated with an imbalance in intestinal bacteria. To date, few studies have evaluated the efficacy and safety of probiotic administration in patients with constipation-variant IBS. A new agent recently available in clinical practice is a symbiotic consisting of a probiotic, Bifidobacterium longum W11, and the short chain oligosaccharide prebiotic Fos Actilight. The aim of this study was to evaluate the efficacy and safety of this symbiotic in patients with constipation-variant IBS.