Can a probiotic get things moving? new trial tests b. longum for constipation

NCT ID NCT06686420

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether a daily supplement containing the B. longum probiotic can help adults who have infrequent bowel movements (less than 3 per week). Over 8 weeks, 80 participants will take either the probiotic or a placebo and track their bowel habits. The goal is to see if the supplement increases bowel movement frequency and improves stool consistency.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
B. longum probiotic supplement
What this could lead to
If it works, this could offer a natural, over-the-counter option to help relieve constipation without medication.
What could go wrong
This is a small, early-stage trial with only 80 participants. The supplement may not work better than a placebo, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Atlantia Clinical Trials

    Chicago, Illinois, 60611, United States