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

ConditionFunctional Constipation (FC)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorChung Shan Medical University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

165 Participants

are divided into 3 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: Low dose of ABKefirExperimental treatment 1 intervention

Group C: High dose of ABKefirExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change from baseline symptoms of constipation at week 4 and 8

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

Time frame

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.

Time frame

Week 0, 4 and 8

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chung Shan Medical University

Lead sponsor

SYNBIO TECH INC. Kaohsiung Taiwan

Collaborator

Source ClinicalTrials.gov

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