Probiotics Alleviate Functional Constipation in Adults

NCT ID: NCT06879587

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-08
• Study Completion Date: 2024-12-17

Brief Summary

To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic Group

Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

During the intervention, participants could take BC99 daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.

Placebo Group

Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

During the intervention, participants could take maltodextrin daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.

Interventions

Probiotic

During the intervention, participants could take BC99 daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

During the intervention, participants could take maltodextrin daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Chinese adults aged 18-70 who meet the following Rome-IV diagnostic criteria for Functional constipation:

i. If the following symptoms started at least 6 months ago and have been present for the past 3 months with two or more of the following:

1. Straining during more than 25% of defecations

2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations

3. Sensation of incomplete evacuation more than 25% of defecations

4. Sensation of anorectal obstruction/blockage more than 25% of defecations

5. Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)

6. Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.

2. Able to complete the study according to the requirements of the trial protocol;

3. Patients who have signed the informed consent form;

4. Research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures.

Only those who meet all the above conditions can be selected for the study. -

Exclusion Criteria

1. The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.

2. Regular use of a high-fiber diet, as measured by the recommended food score (RFS);

3. Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.

4. Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon.

5. Medical history of cardiovascular, liver, or renal diseases; alcoholics.

6. Hypersensitivity to probiotics or the ingredients used in this study.

7. Pregnancy or breastfeeding.

8. Participation in another clinical trial in the 3 months before enrollment. All participants provided written informed consent. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan University of Technology

Zhengzhou, Henan, China

Countries

China

Other Identifiers

WK2024019

Identifier Type: -

Identifier Source: org_study_id