Investigation of the Effects of a Bifidobacterial Strain on Bowel Movement in Healthy Adults

NCT06686420 | Active Not Recruiting

• 1 other identifier: AFCRO-171
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infrequent Bowel Movements

Outcome Measures

Primary Outcomes (1)

• Change in SBM frequency

  Change in mean weekly frequency of SBM, as measured by the daily bowel diary from baseline to the end of intervention. Frequency will be defined as the mean weekly number of SBM during the 2-week run-in period prior to Visit 2, for baseline, and during the final 2-week period of the intervention prior to Visit 3, for end of intervention.

  From baseline to Week 8

Secondary Outcomes (4)

• Change in SBM frequency

  From baseline to Week 2, Week 4 and Week 6

• Change in stool consistency

  From baseline to Week 8

• Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire

  From baseline to Week 4 and Week 8

• Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire

  From baseline to Week 4 and Week 8

Study Arms (2)

B. longum

EXPERIMENTAL

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

Dietary Supplement: B. longum

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

B. longum DIETARY_SUPPLEMENT

On the first day of the intervention period, participants will be instructed to consume two capsules of the live B. longum strain daily with a glass of water before breakfast for the next eight weeks.

B. longum

Placebo DIETARY_SUPPLEMENT

On the first day of the intervention period, participants will be instructed to consume two capsules, which are without any live bacteria, daily. They should take these before breakfast with a glass of water, for the following eight weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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).
• Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.
• Sexual partner(s) is/are exclusively female.
• 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.
• 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.

Sponsors & Collaborators

• Morinaga Milk Industry Co., LTD: lead

Study Sites (1)

Atlantia Clinical Trials

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

galacto-N-biose-lacto-N-biose I phosphorylase, Bifidobacterium longum

Study Officials

• Stacey Boetto

  STTI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 13, 2024
• Study Start: May 1, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)