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
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