Probiotics Alleviate Functional Constipation in Adults

NCT06879587 | Completed

• 1 other identifier: WK2024019
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in colonic transit time (CTT) from baseline to 8 weeks

  Colonic transit time (hours) was measured by radiolabmarking, and the reduction from baseline was an indicator of effectiveness.

  Week 0 and Week 8

• Change in Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to 8 weeks.

  The PAC-SYM questionnaire was used to assess the severity of constipation symptoms (12 items, 0-4 Likert score), with a total score ranging from 0-48 (the lower the score, the milder the symptoms). The magnitude of the decline from the baseline score is an indicator of effectiveness.

  Week 0 and Week 8

Study Arms (2)

Probiotic Group

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic 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.

Probiotic Group

Placebo 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Straining during more than 25% of defecations
• Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations
• Sensation of incomplete evacuation more than 25% of defecations
• Sensation of anorectal obstruction/blockage more than 25% of defecations
• Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
• Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.
• Able to complete the study according to the requirements of the trial protocol;
• Patients who have signed the informed consent form;
• 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. -

You may not qualify if:

• The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.
• Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
• Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
• 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.
• Medical history of cardiovascular, liver, or renal diseases; alcoholics.
• Hypersensitivity to probiotics or the ingredients used in this study.
• Pregnancy or breastfeeding.
• Participation in another clinical trial in the 3 months before enrollment. All participants provided written informed consent. -

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Henan University of Technology

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Constipation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 17, 2025
• Study Start: September 8, 2024
• Primary Completion: October 7, 2024
• Study Completion: December 17, 2024
• Last Updated: March 17, 2025

Record last verified: 2024-09

Locations

CN (1)