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

Chung Shan Medical University

Status: Enrolling

Conditions: Functional Constipation (FC)

Treatments: Dietary Supplement: Probiotics (ABKefir); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06969872

CS2-24134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Low dose of ABKefir

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotics (ABKefir)

High dose of ABKefir

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotics (ABKefir)