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NCT Number: NCT06969872

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, South, 402, Taiwan

Location status: Recruiting

Location contact

Chin-Lin Hsu, Professor

CONTACT

[email protected]

04-24730022 ext. 12222

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary 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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chin-Lin Hsu, Professor

CONTACT

[email protected]

04-24730022 ext. 12222

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Collaborators

  • SYNBIO TECH INC. Kaohsiung Taiwan

Registry information

Official study title

The Effects of ABKefir on Functional Constipation in Subjects: a Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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