Probiotics Alleviate Functional Constipation in Adults

March 10, 2025 updated by: Wecare Probiotics Co., Ltd.

Assessing the Safety and Effectiveness of Bacillus Coagulans BC99 in Relieving Functional Constipation in Adults Based on Randomized, Double-Blind, Placebo-Controlled Trials

To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Henan University of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Chinese adults aged 18-70 who meet the following Rome-IV diagnostic criteria for Functional constipation:

    i. If the following symptoms started at least 6 months ago and have been present for the past 3 months with two or more of the following:

    1. Straining during more than 25% of defecations
    2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations
    3. Sensation of incomplete evacuation more than 25% of defecations
    4. Sensation of anorectal obstruction/blockage more than 25% of defecations
    5. Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
    6. Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.
  2. Able to complete the study according to the requirements of the trial protocol;
  3. Patients who have signed the informed consent form;
  4. Research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures.

Only those who meet all the above conditions can be selected for the study. -

Exclusion Criteria:

  1. The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.
  2. Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
  3. Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
  4. Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon.
  5. Medical history of cardiovascular, liver, or renal diseases; alcoholics.
  6. Hypersensitivity to probiotics or the ingredients used in this study.
  7. Pregnancy or breastfeeding.
  8. Participation in another clinical trial in the 3 months before enrollment. All participants provided written informed consent. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic Group
Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).
Dietary supplement: Probiotic
During the intervention, participants could take BC99 daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.
Placebo Comparator: Placebo Group
Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).
Dietary supplement: Placebo
During the intervention, participants could take maltodextrin daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in colonic transit time (CTT) from baseline to 8 weeks
Time Frame: Week 0 and Week 8
Colonic transit time (hours) was measured by radiolabmarking, and the reduction from baseline was an indicator of effectiveness.
Week 0 and Week 8
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to 8 weeks.
Time Frame: Week 0 and Week 8
The PAC-SYM questionnaire was used to assess the severity of constipation symptoms (12 items, 0-4 Likert score), with a total score ranging from 0-48 (the lower the score, the milder the symptoms). The magnitude of the decline from the baseline score is an indicator of effectiveness.
Week 0 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WK2024019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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