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Could a common probiotic soothe IBS diarrhea?

NCT ID NCT07520422

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed trial tested whether a probiotic called Bacillus coagulans can help adults with mild to moderate IBS-D (diarrhea-predominant irritable bowel syndrome). Fifty participants took either the probiotic or a placebo capsule twice daily for 8 weeks. Researchers tracked changes in abdominal pain, stool consistency, and overall symptom severity using standard scales.

What this could mean

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

Active substance
Bacillus coagulans probiotic
What this could lead to
If it works, this could point toward a natural supplement to ease IBS-D symptoms like belly pain and diarrhea.
What could go wrong
This is a small, early-stage trial with only 50 people, so results may not apply to everyone. Probiotics can sometimes cause mild bloating or gas.

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

50 people

The number who actually took part.

Started

Feb 2023

Finished

May 2023

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Male or female ≧ 18 - ≦ 65 years old. Signed informed consent. IBS-Diarrhea patient satisfying Rome III criteria. Male and female subjects in age range of 18 - 65 years and satisfying the Rome III Criteria for mild to moderate IBS-Diarrhea (IBS-D): Recurrent abdominal pain or discomfort, 3 days per month in the last 3 months (12 weeks), associated withmore than 2 of the criteria below. The criteria are fulfilled with symptoms onset 6 months prior to diagnosis Improvement with defecation. Onset associated with a change in stool frequency. Onset associated with a change in stool form (appearance). At least two of the following, at least a quarter of occasions or days (25%): Altered stool frequency (\> 3 bowel movements/day). Altered stool form (loose/watery stools). Altered stool passage (urgency or feeling of incomplete evacuation). Passage of mucus. Bloating or feeling of abdominal distention. Exclusion Criteria The patient will be excluded from the study if assessment by the treating investigator showed evidence for cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose and throat, dermatologic/psychiatric, allergy, major surgery or other diseases as revealed by history, physical examination and existing laboratory assessments which may interfere with the administration. Pregnant or lactating women. Females at child bearing age will be excluded unless they are using acceptable birth control measures (i.e. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence or a vasectomized partner) Patients requiring treatments with non-permitted medication (i.e. 5-HT3 antagonist, spasmolytics, anticholinergics, cholestyramine, anti latulence agents, metoclopramide, gastric-anti secretory agents (proton pump inhibitors; for indications other than Gastroesophageal Reflux Disease (GERD)), narcotics, anti-diarrheal drugs, and systemic steroids) Patients requiring the use of antibiotics either in medicine form of natural (e.g. grapefruit seed extract, olive leaf extract, oil of oregano, colloidal silver and highly concentrated garlic preparations) Exercise and the use of complementary and alternative medicine for IBS symptoms (i.e. peppermint oil, cognitive behavior therapy) during the study should be maintained at the same level prior to the study. Patients exceeding the treatment limits of permitted medication \[(more than 2 days/week during the study period): alginate, antacids and analgesics (limited to acetaminophen ≤ 1000 mg/day, acetylsalicylic acid or NSAIDS no more than 2 tablets/day), (stable dose throughout the study period, anti-depressants (must be on a stable dose \> 3 months), fiber supplements, psyllium hydrophilic mucilloid, gastric anti secretory agents (only for GERD patients who are on a stable dose \> 3 months; patients should be able to differentiate between IBS and GERD symptoms), acetylsalicylic acid ≤ 325 mg/day, sedatives. Deliverance medications: Mild laxatives only if necessary.\]. Any other medications can be used without limits based on the clinical judgment of the treating investigator. Being in another clinical trial 4 weeks before entering the study. Constipated IBS patients. IBS-Diarrhea patients with un-treated lactose intolerance. Regular use of probiotics or using other probiotics during the course of the study. Patients allergic to milk or soy products. Patients using catheters. Patients presented with rectal bleeding, weight loss, iron deficiency anemia, nocturnal symptoms and a family history of colorectal cancer, inflammatory bowel disease and celiac spruce. Patients over 50 diagnosed with Irritable Bowel Syndrome who have not had a colonoscopy in the last 5 years. Patients who have allergies for the active ingredients or any of the excipients Patients presented with any immune-compromised condition (such as AIDS, lymphoma, long term corticosteroid treatment) Patients presented with nausea, vomiting and fever.

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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

  • Medstar Speciality Hospital

    Bangalore, Karnataka, 560092, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.