Infrequent Bowel MovementsNCT06686420
Investigation of the Effects of a Bifidobacterial Strain on Bowel Movement in Healthy Adults
A study testing B. longum in people with Infrequent Bowel Movements, run by Morinaga Milk Industry Co., LTD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infrequent Bowel Movements
- What is being tested?
- B. longum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study, to Assess the Effect of Bifidobacterial Supplementation on Bowel Movements.
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.
Read the detailed description
Constipation significantly impacts the quality of life, and one of the main causes is the disruption of the gut microbiota. Probiotics have been reported to have a beneficial effect on the intestines, and Bifidobacteria, in particular, have shown functionality in relieving constipation.This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterial supplementation intervention on bowel movement in healthy adults.
- Conditions
- Infrequent Bowel Movements
- Being tested
- B. longum, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. longumDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| B. longum | Experimental | Participants will be instructed to consume the capsule containing the live B. longum strain. Receives: Dietary Supplement: B. longum |
| Placebo | Placebo comparator | Participants will be instructed to consume the placebo capsule without any live bacteria. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Week 8
Secondary outcomes (4)
Change in SBM frequency
Change in mean weekly frequency of SBM, as measured by the daily bowel diary from baseline to Week 6. Frequency will be defined as the mean weekly number of SBM from baseline to Week 1-2, baseline to Week 3-4, baseline to Week 5-6.
Measured: From baseline to Week 2, Week 4 and Week 6
Change in stool consistency
Change in mean daily stool consistency as measured from the Bristol Stool Scale (BSS) in the daily bowel dairy from baseline to the end of intervention. Stool Consistency will be defined as the mean daily stool consistency during the 2-week run-in period prior to Visit 2, for baseline, and during the final 2-week period of the intervention, for end of intervention.
Measured: From baseline to Week 8
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
Change in self-reported constipation related symptoms as assessed by the Total Score of the Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire.
Measured: From baseline to Week 4 and Week 8
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
Change in self-reported impact of constipation on Quality of Life as assessed by the Total Score of the Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire.
Measured: From baseline to Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 May 2024
- Primary completion31 Aug 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infrequent Bowel MovementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morinaga Milk Industry Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stacey Boetto, Principal investigator, STTI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686420
- Sponsor's protocol ID
- AFCRO-171
- Status last verified
- Aug 2025
- First submitted
- 28 Oct 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Study, to Assess the Effect of Bifidobacterial Supplementation on Bowel Movements.
- ClinicalTrials.gov ID
- NCT06686420
- Acronym / sponsor ID
- AFCRO-171
- Conditions
- Infrequent Bowel Movements
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Morinaga Milk Industry Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Constipation significantly impacts the quality of life, and one of the main causes is the disruption of the gut microbiota. Probiotics have been reported to have a beneficial effect on the intestines, and Bifidobacteria, in particular, have shown functionality in relieving constipation.This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterial supplementation intervention on bowel movement in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B. longum | Experimental | Dietary Supplement: B. longumParticipants will be instructed to consume the capsule containing the live B. longum strain. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will be instructed to consume the placebo capsule without any live bacteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (24 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B. longumOn 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. | Dietary supplement | B. longum |
| PlaceboOn 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. | Dietary supplement | Placebo |
Primary outcome
Change in SBM frequency
Time frame: From baseline to Week 8
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.
4 secondary outcomes
Change in SBM frequency
Time frame: From baseline to Week 2, Week 4 and Week 6
Change in stool consistency
Time frame: From baseline to Week 8
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
Time frame: From baseline to Week 4 and Week 8
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
Time frame: From baseline to Week 4 and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Boetto principal investigator
STTI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. longum in people with Infrequent Bowel Movements, run by Morinaga Milk Industry Co., LTD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SBM frequency (time frame: From baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.