Effects of Probiotics on Symptoms of Constipation in Adults With Functional Constipation

NCT ID: NCT06969872

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-27

Study Completion Date

2026-09-30

Brief Summary

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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

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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

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Functional Constipation (FC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

The composition of placebo capsules is same as the experimental capsules, except that they don't contain probiotics.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Take a capsule of placebo within 30 minutes after breakfast, and once a day.

Low dose of ABKefir

Low dose of probiotics, 5×10\^9 CFU/capsule

Group Type EXPERIMENTAL

Probiotics (ABKefir)

Intervention Type DIETARY_SUPPLEMENT

Take a capsule of ABKefir within 30 minutes after breakfast, and once a day.

High dose of ABKefir

High dose of probiotics, 1×10\^10 CFU/capsule

Group Type EXPERIMENTAL

Probiotics (ABKefir)

Intervention Type DIETARY_SUPPLEMENT

Take a capsule of ABKefir within 30 minutes after breakfast, and once a day.

Interventions

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Placebo

Take a capsule of placebo within 30 minutes after breakfast, and once a day.

Intervention Type DIETARY_SUPPLEMENT

Probiotics (ABKefir)

Take a capsule of ABKefir within 30 minutes after breakfast, and once a day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SYNBIO TECH INC. Kaohsiung Taiwan

UNKNOWN

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsin-Chi Pan, MS student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, South, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin-Lin Hsu, Professor

Role: CONTACT

04-24730022 ext. 12222

Facility Contacts

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Chin-Lin Hsu, Professor

Role: primary

04-24730022 ext. 12222

Other Identifiers

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CS2-24134

Identifier Type: -

Identifier Source: org_study_id

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