Probiotics for Alleviating Functional Constipation in Adults

NCT06637397 | Completed

• 1 other identifier: WK2024007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 (1)

• Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.

  Constipation symptoms are measured using Bristol Stool Form Scale (BSFS).

  8 weeks

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 can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

Probiotic Group

Placebo DIETARY_SUPPLEMENT

During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

Placebo Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese adults who met the Rome III diagnostic criteria and were aged ≥20 years;
• patients with chronic constipation (duration of more than 6 months, with less than 3 bowel movements per week and/or Bristol Scale Type 1 and 2);
• patients in whom loose stools were rare without the use of laxatives;
• The criteria for irritable bowel syndrome were insufficient;
• patients that could complete the study according to the requirements of the trial protocol;
• patients that had signed the informed consent form;
• the study participants (including male subjects) had no fertility plans within 14 days before screening, and would voluntarily take effective contraceptive measures within 6 months after the end of the trial.
• Only those who met all of the above conditions could be selected.

You may not qualify if:

• (1) Those who took items with similar functions to the test subjects in the short term, which may have affected their judgment of the results; (2) those who regularly used drugs that affect bowel habits; (3) patients who changed their diet during the study (such as regularly using a high-fiber diet, according to the recommended food score (RFS)); (4) those who were allergic to probiotics or the ingredients used in this study, those with severe immunodeficiency, or those with serious psychological or psychiatric diseases; (5) women who were pregnant, breastfeeding, or planning to become pregnant; (6) those who suffered from diseases that may cause secondary constipation, such as diabetes, thyroid disease, Alzheimer's disease, severe metabolic diseases, malignant tumors, and severe lesions of important organs (cardiovascular, lung, liver, kidney, etc.); (7) those who had used antibiotics in the two weeks prior; (8) those who did not consume the test samples as required, or were not followed up on time, resulting in uncertainty of efficacy; (9) those who had participated in another clinical trial within one month before enrollment; (10) subjects who were judged by other researchers to be unsuitable for participation. Those who met any of the above conditions were not selected.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (2)

Henan University of Science and Technology

Luoyang, Henan, 471000, China

Location

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, 471000, China

Location

Related Publications (1)

• Wu Y, Zhou Y, Fan Q, Gao Y, Fang S, Sun Y, Gu S. Weizmannia coagulans BC99 improved intestinal motility and chronic constipation through regulating gut microbiota: a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2026 Mar 26;65(3):106. doi: 10.1007/s00394-026-03953-5.

  PMID: 41886091 DERIVED

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: May 27, 2024
• First Posted: October 15, 2024
• Study Start: July 4, 2024
• Primary Completion: October 2, 2024
• Study Completion: October 20, 2024
• Last Updated: July 29, 2026

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)