Constipation - FunctionalNCT04997187
Effect of Bacillus Coagulans in Adults With With Functional Constipation
A study testing Bacillus coagulans group in people with Constipation - Functional, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Bacillus coagulans group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2021to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- function constipation by Romes criteria IV
Who cannot join
- Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
- Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
- Uncontrolled hypertension (>160/100 mmHg)
- Uncontrolled thyroid diseases.
- History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
- History of structural abnormalities of colon within 4 year
Show all 13Show fewer
- History of medication for probiotics and psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
- Alcohol abuser
- Allergic reaction to this test food
- Those who participated in other drug clinical trials within 1 month from the screening date.
- Severe gastrointestinal symptoms such as heartburn and indigestion
- Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
- Those who are judged to be unsuitable by the PI for other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
Official title: Effect of Bacillus Coagulans on Various Symptoms and Fecal Microbial Diversity in Adults With With Functional Constipation: a Randomized, Double-blinded, Placebo-controlled Trial
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks.
Read the detailed description
A previous study has indicated that Bacillus coagulans provided control of abdominal pain, less discomfort during defecation, and a more normalized defecation style, especially in adults with with functional constipation. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans various symptoms and fecal microbial diversity in adults with with functional constipation for 8 weeks; the safety of the compound are also evaluated. The Investigators examine constipation visual analogue scale, Bristol Stool Form Scale type 3 \& 4 ratio, visual analogue scale for irritable bowel syndrome (VAS-IBS) questionnaire score, IBS-symptom severity scale, IBS quality-of-life questionnaire score, fecal microbial diversity at baseline, as well as after 8 weeks of intervention. Eighty adults were administered either 400 mg of Bacillus coagulans or a placebo each day for 8 weeks.
- Conditions
- Constipation - Functional
- Being tested
- Bacillus coagulans group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus coagulans groupDietary supplement
Bacillus coagulans 400 mg/day for 12 weeks
Control groupDietary supplement
Placebo 400 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bacillus coagulans group | Experimental | This group takes Bacillus coagulans for 12 weeks. Receives: Dietary Supplement: Bacillus coagulans group |
| Control group | Placebo comparator | This group takes placebo for 12 weeks. Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
constipation visual analogue scale
using visual analogue scale (100 mm). The minimum value was 0 mm and the maximum value was 100 mm, and higher scores mean a worse outcome.
Measured: 8 weeks
Secondary outcomes (5)
Bristol Stool Form Scale (BSFS) type 1 & 2 ratio (%)
using Bristol Stool Form Scale. The minimum value was 0% and the maximum value was 100%, and higher scores mean a better outcome.
Measured: 8 weeks
visual analogue scale for irritable bowel syndrome
using visual analogue scale (100 mm). The minimum value was 0 mm and the maximum value was 100 mm, and higher scores mean a better outcome.
Measured: 8 weeks
irritable bowel syndrome-symptom severity scale
using IBS-Symptom Severity Scale questionnaire. The minimum value was 0 score and the maximum value was 500 score and higher scores mean a worse outcome.
Measured: 8 weeks
irritable bowel syndrome-quality-of-life
using IBS-QOL questionnaire. The minimum value was 0 score and the maximum value was 5 score and higher scores mean a better outcome.
Measured: 8 weeks
fecal microbial diversity
using gut microbiome analysis
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start20 Jul 2021
- Primary completion27 Feb 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997187
- Sponsor's protocol ID
- 02-2021-008
- Status last verified
- Apr 2023
- First submitted
- 30 Jul 2021
- Last updated
- 6 Jan 2026
- Results posted
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bacillus Coagulans on Various Symptoms and Fecal Microbial Diversity in Adults With With Functional Constipation: a Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04997187
- Acronym / sponsor ID
- 02-2021-008
- Conditions
- Constipation - Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 9 Aug 2021 (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 investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks.
Detailed description
A previous study has indicated that Bacillus coagulans provided control of abdominal pain, less discomfort during defecation, and a more normalized defecation style, especially in adults with with functional constipation. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans various symptoms and fecal microbial diversity in adults with with functional constipation for 8 weeks; the safety of the compound are also evaluated. The Investigators examine constipation visual analogue scale, Bristol Stool Form Scale type 3 \& 4 ratio, visual analogue scale for irritable bowel syndrome (VAS-IBS) questionnaire score, IBS-symptom severity scale, IBS quality-of-life questionnaire score, fecal microbial diversity at baseline, as well as after 8 weeks of intervention. Eighty adults were administered either 400 mg of Bacillus coagulans or a placebo each day for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacillus coagulans group | Experimental | Dietary Supplement: Bacillus coagulans groupThis group takes Bacillus coagulans for 12 weeks. |
| Control group | Placebo comparator | Dietary Supplement: Control groupThis group takes placebo for 12 weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- function constipation by Romes criteria IV
Key exclusion criteria (13 listed)
- Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
- Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
- Uncontrolled hypertension (>160/100 mmHg)
- Uncontrolled thyroid diseases.
- History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
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 |
|---|---|---|
| Bacillus coagulans groupBacillus coagulans 400 mg/day for 12 weeks | Dietary supplement | Bacillus coagulans group |
| Control groupPlacebo 400 mg/day for 12 weeks | Dietary supplement | Control group |
Primary outcome
constipation visual analogue scale
Time frame: 8 weeks
using visual analogue scale (100 mm). The minimum value was 0 mm and the maximum value was 100 mm, and higher scores mean a worse outcome.
5 secondary outcomes
Bristol Stool Form Scale (BSFS) type 1 & 2 ratio (%)
Time frame: 8 weeks
visual analogue scale for irritable bowel syndrome
Time frame: 8 weeks
irritable bowel syndrome-symptom severity scale
Time frame: 8 weeks
irritable bowel syndrome-quality-of-life
Time frame: 8 weeks
fecal microbial diversity
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- 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.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus coagulans group in people with Constipation - Functional, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 1 inclusion and 13 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: finished, as of the sponsor's last update on 6 Jan 2026. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
constipation visual analogue scale (time frame: 8 weeks). 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 6 Jan 2026.