Effects of a Bifidobacterial Strain on Bowel Movements in Healthy Adults

A Randomized, Double-blind, Placebo-controlled, Parallel Study, to Assess the Effect of Bifidobacterial Supplementation on Bowel Movements.

This study is testing if a daily supplement with a specific type of bacteria can help healthy adults have more regular bowel movements and feel better overall.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Morinaga Milk Industry Co., LTD (Industry-sponsored)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06686420 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of a supplement containing the B. longum strain on alleviating constipation in healthy adults. Participants will take either the B. longum supplement or a placebo daily for 8 weeks while maintaining an e-diary to track their bowel movements. The study aims to determine if the supplement increases the frequency of spontaneous bowel movements, improves stool consistency, and enhances overall quality of life. Participants will undergo screening assessments and submit stool samples at the beginning and end of the intervention.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 who experience less than 3 bowel movements per week.

Not a fit: Patients who are pregnant, breastfeeding, or not using effective contraception will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new probiotic treatment option for individuals suffering from infrequent bowel movements.

How similar studies have performed: Previous studies have shown that probiotics, including Bifidobacteria, can have beneficial effects on bowel health, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Is willing to participate in the study and comply with its procedures.
* Be able to give written informed consent.
* Adults aged ≥18 years and ≤65 years.
* Experience less than 3 bowel movements per week within the past three months.
* ≥25% of bowel movements with stool firmness, less than Type-3 based on Bristol Stool Scale (BSS), within the past three months.
* Record less than 6 bowel movements in eDiary App during the two-week run-in period.
* 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.
* Participants currently of biological childbearing potential, but not using continuous effective method of contraception, as outlined below:

  1. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final Visit).
  2. Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
  3. Sexual partner(s) is/are exclusively female.
  4. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
  5. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first Screening Visit, throughout the study, and two weeks following the end of the study.
* Participants reporting current, or historical alcohol or drug abuse in the past year.
* Participants who have quit smoking in the 6-months prior to screening.
* Participants with a known allergy to the Study Product's active or inactive ingredients.
* Participants with chronic disease who require long-term medication throughout the whole study period.
* Participants with a significant acute, chronic or un-controlled coexisting illness or is taking medication/supplements that would put the Participant at risk or confound the interpretation of the study results, as judged by the investigator.
* Participants who regularly take medications, that are thought to affect defecation, including regular laxative use. (Occasional laxative use (PRN) \< 3 times per month is acceptable).
* Participants who regularly consume supplements that are thought to affect defecation, including but not limited to fiber, iron, and magnesium.
* Participants who are consuming oral antibiotics at screening, during run-in and for the duration of the study.
* Participants who have consumed probiotic supplements and prebiotic supplements 8 weeks prior to Visit 2.
* Participants who have consumed fermented foods, that aid in bowel movement improvement such as yogurt, kefir, sauerkraut, kimchi, soy-based fermented food, miso, natto and fermented cheese, etc. within the 4 weeks prior to Visit 2.
* Participants who are diagnosed with or undergoing treatment for any gastrointestinal conditions such as coeliac disease, diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, gastroesophageal reflux disease (GERD) or have undergone significant gastrointestinal surgery (appendectomy allowed).
* Participants diagnosed with clinical depression, Parkinson's disease, anxiety, or an anxiety related disorder, who are undergoing treatment with medication.
* Participants with clinically significant abnormal laboratory results at screening.
* Individuals who are cognitively impaired and/or who are unable to give informed consent.
* Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
* Any Participant who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
* Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.

Where this trial is running

Chicago, Illinois

• Atlantia Clinical Trials — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Stacey Boetto — Stti
• Study coordinator: Barry Skillington, PhD

Conditions Infrequent Bowel Movements