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

NCT06969872 | Recruiting

• 1 other identifier: CS2-24134
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Constipation (FC)

Outcome Measures

Primary Outcomes (2)

• Change from baseline symptoms of constipation at week 4 and 8

  Compared the difference of bowel movements between the week 0, 4 and 8.

  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.

  Week 0, 4 and 8

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Low dose of ABKefir

EXPERIMENTAL

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

Dietary Supplement: Probiotics (ABKefir)

High dose of ABKefir

EXPERIMENTAL

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

Dietary Supplement: Probiotics (ABKefir)

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo

Probiotics (ABKefir) DIETARY_SUPPLEMENT

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

High dose of ABKefir; Low dose of ABKefir

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SYNBIO TECH INC. Kaohsiung Taiwan: collaborator
• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, South, 402, Taiwan

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hsin-Chi Pan, MS student

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Lin Hsu, Professor

CONTACT

04-24730022; clhsu@csmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 14, 2025
• Study Start: December 27, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

TW (1)