Functional Constipation (FC)NCT06969872
Effects of Probiotics on Symptoms of Constipation in Adults With Functional Constipation
A study testing Probiotics (ABKefir) in people with Functional Constipation (FC), run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The purpose of this study was to evaluate the efficacy of 1 capsules of ABKefir per day on symptoms of constipation in subjects with functional constipation by clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- Probiotics (ABKefir)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Dec 2024to 30 Sep 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female
- aged 18-75 years old
- fulfill Rome IV criteria for functional constipation
- have not participated in similar research in the past three months
Who cannot join
- Personal or family history of colon cancer, celiac disease, and inflammatory bowel disease
- Irritable bowel syndrome diagnosed during colonoscopy
- Those who are pregnant recently (including men and women), or are pregnant or breastfeeding women.
- Taking antidepressants, anti-anxiety drugs and other psychotropic drugs.
- Long-term medication is required to improve constipation
- Those diagnosed with myocardial infarction, cerebral infarction, malignant tumor and/or other serious diseases are not suitable for participating in the study.
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- Allergic symptoms to probiotics or any ingredients
- Having a history of serious mental illness
- Drug-related crimes or alcohol problems
- Have recently traveled to areas where parasitic diseases are prevalent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University
Taichung, South, 402
Chin-Lin Hsu, Professor, 04-24730022 ext. 12222, clhsu@csmu.edu.tw
About this study
Official title: The Effects of ABKefir on Functional Constipation in Subjects: a Randomized, Double-blind, Placebo-controlled Trial
The purpose of this study was to evaluate the efficacy of 1 capsules of ABKefir per day on symptoms of constipation in subjects with functional constipation by clinical trial.
Read the detailed description
This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with one hundred and sixty-five adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 55; (2) low dose of ABKefir , n = 55; (3) high dose of ABKefir, n = 55. During the first 4 weeks of supplement, the subjects should take one capsule of placebo or ABKefir daily. Apart from containing no probiotics, the content of placebo is same as ABKefir. After that, the next 4 weeks is to have a follow-up of subjects. During this phase, subjects don't need to supplement. Subjects should complete the assessment of anthropometric measurement, defecation questionnaire , food record, feces and blood collection at week 0, 4 and week 8.
- Conditions
- Functional Constipation (FC)
- Being tested
- Placebo, Probiotics (ABKefir)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Take a capsule of placebo within 30 minutes after breakfast, and once a day.
Probiotics (ABKefir)Dietary supplement
Take a capsule of ABKefir within 30 minutes after breakfast, and once a day.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The composition of placebo capsules is same as the experimental capsules, except that they don't contain probiotics. Receives: Dietary Supplement: Placebo |
| Low dose of ABKefir | Experimental | Low dose of probiotics, 5×10^9 CFU/capsule Receives: Dietary Supplement: Probiotics (ABKefir) |
| High dose of ABKefir | Experimental | High dose of probiotics, 1×10^10 CFU/capsule Receives: Dietary Supplement: Probiotics (ABKefir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline symptoms of constipation at week 4 and 8
Compared the difference of bowel movements between the week 0, 4 and 8.
Measured: Week 0, 4 and 8
Change from baseline symptoms of constipation at week 4 and 8
Compared the difference of stool consistency between the week 0, 4 and 8.
Measured: Week 0, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start27 Dec 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- SYNBIO TECH INC. Kaohsiung Taiwan
- Responsible party
- Sponsor
- Investigators
- Hsin-Chi Pan, MS student, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969872
- Sponsor's protocol ID
- CS2-24134
- Status last verified
- Dec 2025
- First submitted
- 29 Apr 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of ABKefir on Functional Constipation in Subjects: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06969872
- Acronym / sponsor ID
- CS2-24134
- Conditions
- Functional Constipation (FC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- SYNBIO TECH INC. Kaohsiung Taiwan
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 14 May 2025 (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 purpose of this study was to evaluate the efficacy of 1 capsules of ABKefir per day on symptoms of constipation in subjects with functional constipation by clinical trial.
Detailed description
This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with one hundred and sixty-five adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 55; (2) low dose of ABKefir , n = 55; (3) high dose of ABKefir, n = 55. During the first 4 weeks of supplement, the subjects should take one capsule of placebo or ABKefir daily. Apart from containing no probiotics, the content of placebo is same as ABKefir. After that, the next 4 weeks is to have a follow-up of subjects. During this phase, subjects don't need to supplement. Subjects should complete the assessment of anthropometric measurement, defecation questionnaire , food record, feces and blood collection at week 0, 4 and week 8.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe composition of placebo capsules is same as the experimental capsules, except that they don't contain probiotics. |
| Low dose of ABKefir | Experimental | Dietary Supplement: Probiotics (ABKefir)Low dose of probiotics, 5×10^9 CFU/capsule |
| High dose of ABKefir | Experimental | Dietary Supplement: Probiotics (ABKefir)High dose of probiotics, 1×10^10 CFU/capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female
- aged 18-75 years old
- fulfill Rome IV criteria for functional constipation
- have not participated in similar research in the past three months
Key exclusion criteria (10 listed)
- Personal or family history of colon cancer, celiac disease, and inflammatory bowel disease
- Irritable bowel syndrome diagnosed during colonoscopy
- Those who are pregnant recently (including men and women), or are pregnant or breastfeeding women.
- Taking antidepressants, anti-anxiety drugs and other psychotropic drugs.
- Long-term medication is required to improve constipation
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 |
|---|---|---|
| PlaceboTake a capsule of placebo within 30 minutes after breakfast, and once a day. | Dietary supplement | Placebo |
| Probiotics (ABKefir)Take a capsule of ABKefir within 30 minutes after breakfast, and once a day. | Dietary supplement | High dose of ABKefir, Low dose of ABKefir |
Primary outcome
Change from baseline symptoms of constipation at week 4 and 8
Time frame: Week 0, 4 and 8
Compared the difference of bowel movements between the week 0, 4 and 8.
Change from baseline symptoms of constipation at week 4 and 8
Time frame: Week 0, 4 and 8
Compared the difference of stool consistency between the week 0, 4 and 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 2 Jan 2026.
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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.
Hsin-Chi Pan, MS student principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics (ABKefir) in people with Functional Constipation (FC), run by Chung Shan Medical University at 1 site in Taiwan.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 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 Taiwan. 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?
Contact Chin-Lin Hsu, Professor (04-24730022 ext. 12222, clhsu@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline symptoms of constipation at week 4 and 8 (time frame: Week 0, 4 and 8). The study lists 2 primary outcomes in all. 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 2 Jan 2026.